Phase 3
Completed N=294
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
Source: ClinicalTrials.gov NCT01120600 ↗Enrolled (actual)
294
Serious AEs
16.4%
Results posted
Dec 2017
Primary outcomePrimary: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 — 6.86; 1.27 Percentage change — p=< 0.001
◆ Published Evidence
Established
21citations · ~4 / year
Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis.
Summary
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.
Linked Publications
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Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 |
6.86; 1.27 | < 0.001 sig |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
113; 114 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an AE |
5; 6 | — |
| SECONDARY Percentage Change From Baseline in Total Hip BMD at Month 24 |
1.91; -0.11 | < 0.001 sig |
| SECONDARY Percentage Change From Baseline in Femoral Neck BMD at Month 24 |
1.69; 0 | = 0.008 sig |
| SECONDARY Percentage Change From Baseline in Trochanter BMD at Month 24 |
2.77; 0.66 | < 0.001 sig |
| SECONDARY Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 |
-20.07; 56.51 | < 0.001 sig |
| SECONDARY Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 |
-61.43; 6.65 | < 0.001 sig |
| SECONDARY Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 |
-5.28; 2.66 | = 0.019 sig |
| SECONDARY Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 |
-10.94; 5.06 | = 0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01120600) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.