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临床试验/NCT01769469
NCT01769469已完成不适用

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

University of North Carolina, Chapel Hill12 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2012年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
12
主要终点
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 22 Years（Child, Adult）
性别
Male
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Subjects Enrolled in ATN 110 or ATN 113

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.

干预措施: FTC/TDF (Truvada®) (Drug)

结局指标

主要结局

Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48

时间窗: 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).

次要结局

  • 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)
  • 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)
  • 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)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Magnitude of Most Extreme Fold Change: UCa/UCr Ratio(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change(Baseline and wk 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)(Baseline and wk 48)
  • Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)(Baseline and wk 48)
  • 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)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change(Baseline and wk 48)
  • 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)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change From Baseline to Week 48 in Serum Calcium (SCa)(Baseline and wk 48)
  • Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • 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)
  • Time to Most Extreme Fold Change: Serum Calcium (SCa)(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • 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)
  • Time to Most Extreme Fold Change: UCa/UCr Ratio(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)(Baseline and wk 48)
  • Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)(Baseline and wk 48)
  • 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)
  • 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)
  • Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)(Baseline and wk 48)
  • Magnitude of Most Extreme Fold Change: SPO4(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change From Baseline to Week 48 in Serum Phosphate (SPO4)(Baseline and wk 48)
  • 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)
  • Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)(Baseline and wk 48)
  • Time to Most Extreme Fold Change: SPO4(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)(Baseline and wk 48)
  • 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)
  • Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)(Baseline and wk 48)
  • Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • 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)
  • Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • 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)
  • Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr(Baseline, 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 Scr(Baseline, 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 UB2MG(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)(Baseline and wk 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)(Baseline and wk 48)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change(Baseline, Weeks 4, 8, 12, 24, 36, and 48)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)(Baseline, Weeks 4, 8, 12, 24, 36 and 48)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline(Baseline and wk 72)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Magnitude of Change in Lumbar Spine BMD at Week 48(Baseline and wk 48)
  • 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)
  • Magnitude of Change in Femoral Neck BMD at Week 48(Baseline and wk 48)
  • Magnitude of Change in Total Body BMC at Week 48(Baseline and wk 48)
  • Magnitude of Change in Lumbar Spine BMD Z-score at Week 48(Baseline and wk 48)
  • Magnitude of Change in Femoral Neck BMD Z-score at Week 48(Baseline and wk 48)
  • 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)
  • 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)
  • Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline(Baseline and wk 72)
  • Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline(Baseline and wk 96)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline(Baseline and wk 72)
  • Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline(Baseline and wk 96)
  • Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline(Baseline and wk 96)
  • Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline(Baseline and wk 72)
  • Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline(Baseline and wk 72)
  • 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)
  • Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline(Baseline, Week 96)
  • 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)
  • Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline(Baseline and wk 96)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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