Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

Completed

• Conditions: HIV Infection
• Interventions: Drug: FTC/TDF (Truvada®)

• Registration Number: NCT01769469
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.

Detailed Description

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-11-21
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-19
• Results First Posted: 2019-03-11
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

Inclusion Criteria

• Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and
• Willing and able to provide written informed consent

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Exclusion Criteria

-Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects Enrolled in ATN 110 or ATN 113	FTC/TDF (Truvada®)	A subset of 100 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.

Primary Outcome Measures

Name	Time	Method
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48	Baseline and Week (wk) 48	The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).

Secondary Outcome Measures

Name	Time	Method
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change	Baseline and wk 48	The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change	Baseline and wk 48	The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Magnitude of Most Extreme Fold Change: UCa/UCr Ratio	Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change	Baseline and wk 48	The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)	Baseline and wk 48	UB2MG Week 48 difference from baseline
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)	Baseline and wk 48	The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)	Baseline and wk 48	The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change	Baseline and wk 48	The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change From Baseline to Week 48 in Serum Calcium (SCa)	Baseline and wk 48	Serum calcium Week 48 difference from baseline
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time to Most Extreme Fold Change: Serum Calcium (SCa)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Time to Most Extreme Fold Change: UCa/UCr Ratio	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)	Baseline and wk 48	UGluc Week 48 difference from baseline
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)	Baseline and wk 48	SCr Week 48 difference from baseline
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)	Baseline and wk 48	Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline
Magnitude of Most Extreme Fold Change: SPO4	Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change From Baseline to Week 48 in Serum Phosphate (SPO4)	Baseline and wk 48	Serum Phosphate (SPO4) Week 48 difference from baseline
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)	Baseline and wk 48	URBP/UCr Week 48 difference from baseline
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)	Baseline and wk 48	UProt/ UCr Week 48 difference from baseline
Time to Most Extreme Fold Change: SPO4	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)	Baseline and wk 48	The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)	Baseline and wk 48	The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)	Baseline and wk 48	The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)	Baseline and wk 48	OC Week 48 difference from baseline
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)	Baseline and wk 48	CTX Week 48 difference from baseline
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX	Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)	Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC	Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = \[(Most extreme fold change) \* (baseline value) - (baseline value)\] / \[(Time to most extreme fold change) - (time of the baseline value)\]
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline	Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure	Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, and 24.
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Magnitude of Change in Lumbar Spine BMD at Week 48	Baseline and wk 48	The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure	Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.; The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.
Magnitude of Change in Femoral Neck BMD at Week 48	Baseline and wk 48	The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Magnitude of Change in Total Body BMC at Week 48	Baseline and wk 48	The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Magnitude of Change in Lumbar Spine BMD Z-score at Week 48	Baseline and wk 48	The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Magnitude of Change in Femoral Neck BMD Z-score at Week 48	Baseline and wk 48	The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)	W 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline	Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline	Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)	Week 48 (or last available measurement on study), Week 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline	Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline	Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline	Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline	Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline	Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline	Baseline, Week 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2); The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).; The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline	Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)	Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).; This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)

Trial Locations

Locations (12)

Children's Hopsital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Hospital of Denver; 🇺🇸 Aurora, Colorado, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Stroger Hospital and the CORE Center; 🇺🇸 Chicago, Illinois, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Children's Hopsital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Fenway Institute; 🇺🇸 Boston, Massachusetts, United States

St. Jude Childrens Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States