A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Placebo; Drug: Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium

• Registration Number: NCT00885170
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-13
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2011-09-15
• Study Completion: 2011-09-15
• Results First Submitted: 2017-01-03
• Results First Submitted QC: 2017-03-06
• Results First Posted: 2017-04-18
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

• Has been postmenopausal for at least 5 years
• Has taken or is taking alendronate
• Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria

• Has a history or evidence of hip fracture
• Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
• Has active parathyroid disease
• Has a history of thyroid disease not adequately controlled by medication
• Is taking anti-seizure medication and has abnormal calcium metabolism
• Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Placebo	Calcium	Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Odanacatib 50 mg	Calcium	Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Odanacatib 50 mg	Vitamin D3	Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Placebo	Vitamin D3	Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Odanacatib 50 mg	Odanacatib	Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24	Baseline and Month 24	BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Percentage of Participants Discontinuing Study Drug Due to an AE	Up to 24 months	An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Percentage of Participants Experiencing One or More Adverse Events (AEs)	Up to 25 months	An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine BMD at Month 24	Baseline and 24 Months	BMD at the lumbar spine was assessed by DXA at baseline and Month 24.
Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24	Baseline and Month 24	s-CTx is a biochemical marker of bone resorption.
Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24	Baseline and Month 24	The 25-hydroxy vitamin D \[25(OH)D\] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Baseline and 12 Months	BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12	Baseline and 12 Months	BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.
Percent Change From Baseline in Log-Transformed s-CTx at Month 12	Baseline and Month 12	s-CTx is a biochemical marker of bone resorption.
Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24	Baseline and Month 24	N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.
Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12	Baseline and Month 12	s-P1NP is a biochemical marker of bone formation.
Percent Change From Baseline in Femoral Neck BMD at Month 12	Baseline and 12 Months	BMD at the femoral neck was assessed by DXA at baseline and Month 12.
Percent Change From Baseline in Total Hip BMD at Month 24	Baseline and 24 Months	BMD at the total hip was assessed by DXA at baseline and Month 24.
Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24	Baseline and Month 24	Serum phosphate is an index of mineral homeostasis.
Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24	Baseline and Month 24	Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.
Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24	Baseline and Month 24	1,25 dihydroxyvitamin D \[1,25(OH)2 D\] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.
Percent Change From Baseline in Trochanter BMD at Month 24	Baseline and 24 Months	BMD at the trochanter was assessed by DXA at baseline and Month 24.
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24	Baseline and 24 Months	BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.
Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24	Baseline and Month 24	Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.
Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24	Baseline and Month 24	Serum calcium is an index of calcium homeostasis.
Percent Change From Baseline in Trochanter BMD at Month 12	Baseline and 12 Months	BMD at the trochanter was assessed by DXA at baseline and Month 12.
Percent Change From Baseline in Total Hip BMD at Month 12	Baseline and 12 Months	BMD at the total hip was assessed by DXA at baseline and Month 12.
Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12	Baseline and Month 12	u-NTx/Cr is a biochemical marker of bone resorption.
Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24	Baseline and Month 24	Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.
Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12	Baseline and Month 12	BSAP is a biochemical marker of bone formation.