A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Detailed Description
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The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Official Title
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A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Odanacatib
* Drug: Placebo for Odanacatib
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Calcium carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a male between 40 and 95 years of age Has osteoporosis Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip Is ambulatory Exclusion Criteria: Is currently on oral bisphosphonates or other treatment for osteoporosis Had previous hip fragility fracture and is a candidate for standard of care therapy Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months Has had more then one previous vertebral fracture Has been diagnosed with metabolic bone disorder other than osteoporosis Is Vitamin D deficient Has a history of renal stones Has active parathyroid disease Has history of thyroid disease not well controlled by medication Is diagnosed with secondary osteoporosis Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg Has a history of malignancy ≤5 years prior to signing informed consent Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Odanacatib 50 mg once weekly<br>Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. | Drug: Odanacatib<br>* One 50 mg tablet once weekly<br>* Other names: MK-0822;Dietary Supplement: Vitamin D3<br>* 5600 IU of open-label Vitamin D3 once weekly<br>Dietary Supplement: Calcium carbonate<br>* Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg<br>|
| Placebo Comparator: Placebo once weekly<br>Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. | Drug: Placebo for Odanacatib<br>* One 50 mg tablet once weekly<br>Dietary Supplement: Vitamin D3<br>* 5600 IU of open-label Vitamin D3 once weekly<br>Dietary Supplement: Calcium carbonate<br>* Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 | Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24. | Baseline and Month 24 | 
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 24 months (plus 14 days) after first dose of study drug | 
| Number of Participants Who Discontinued Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 24 months after first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Total Hip BMD at Month 24 | Total hip BMD was assessed by DXA at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Femoral Neck BMD at Month 24 | Femoral Neck BMD was assessed by DXA at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Trochanter BMD at Month 24 | Trochanter BMD was assessed by DXA at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 | Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24. | Baseline and Month 24 | 
| Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24. | Baseline and Month 24 |