Phase 2
N=287
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Osteoporosis Postmenopausal
Bottom Line
View on ClinicalTrials.gov: NCT00620113 ↗Enrolled (actual)
287
Serious AEs
6.6%
Results posted
Mar 2017
Primary outcome: Primary: Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4) — 0.55; 4.09; 5.67; 5.94 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Odanacatib (Drug); Vitamin D3 (Dietary_supplement); Calcium carbonate (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4) |
0.55; 4.09; 5.67; 5.94 | <0.001 sig |
| PRIMARY Number of Participants That Experienced an Adverse Event (AE) |
57; 63; 62; 58 | — |
| PRIMARY Number of Participants That Discontinued Study Drug Due to an AE |
3; 2; 1; 1 | — |
| SECONDARY Percent Change From Baseline to Week 52 in Total Hip BMD |
-0.35; 1.31; 1.85; 2.70 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Femoral Neck BMD |
-0.72; 1.51; 1.14; 2.35 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Trochanter BMD |
-0.28; 2.16; 3.56; 4.38 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio |
-7.84; -43.59; -52.16; -58.48 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level |
-10.95; -49.68; -71.64; -71.36 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre) |
16.45; -10.32; -21.00; -26.46 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level |
-9.91; -7.44; -22.47; -25.43 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level |
-20.14; -25.75; -48.99; -47.00 | <0.001 sig |
Summary
The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.
The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
- Participant who has low bone mineral density
- Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
- Participant is ambulatory (can walk)
Exclusion Criteria
- Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
- Participant has received osteoporosis medications or other medications that affect bone
- Participant is already participating in another drug study
Data sourced from ClinicalTrials.gov (NCT00620113). 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.