Phase 3
Completed N=214
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
Source: ClinicalTrials.gov NCT00729183 ↗Enrolled (actual)
214
Serious AEs
13.6%
Results posted
May 2017
Primary outcomePrimary: Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD) — 3.63; 0.14 percent change — p=<0.001
◆ Published Evidence
Highly cited
122citations · ~9 / year
Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial.
Summary
This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.
Linked Publications (2)
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Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial.
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Odanacatib treatment affects trabecular and cortical bone in the femur of postmenopausal women: results of a two-year placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD) |
3.63; 0.14 | <0.001 sig |
| PRIMARY Percentage of Participants That Experienced an Adverse Event (AE) |
82.6; 84.8 | — |
| PRIMARY Percentage of Participants That Discontinued Study Treatment Due to an AE |
10.1; 5.7 | — |
| SECONDARY Percent Change From Baseline to Month 24 in Lumbar Spine aBMD |
5.02; -0.38 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Hip aBMD |
1.41; -0.16; 2.43; -0.89 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Femoral Neck aBMD |
1.03; -0.45; 2.47; -1.33 | 0.001 sig |
| SECONDARY Percent Change From Baseline in Hip Trochanter aBMD |
2.37; 0.18; 4.75; -0.73 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Radius aBMD |
0.01; -0.70; -0.19; -1.89 | 0.030 sig |
| SECONDARY Percent Change From Baseline in Ultradistal Radius aBMD |
0.98; -0.73; 1.25; -1.45 | 0.001 sig |
| SECONDARY Percent Change From Baseline in Distal Radius aBMD |
-0.21; -0.37; -0.57; -1.79 | 0.697 |
| SECONDARY Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1) |
6.58; -1.43; 6.44; -5.02 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2) |
5.67; -0.00; 5.97; -3.41 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level |
-53.33; 0.70; -42.56; 3.03 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level |
-28.32; -2.97; -11.06; -1.99 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant has been postmenopausal for 3 years
- Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but > -3.5
- Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures
- Participant is ambulatory
Exclusion Criteria
- Participant has had a previous hip fracture
- Participant has had >1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy
- Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone
- Participant has had metabolic bone disorder other than osteoporosis
- Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease.
Data sourced from ClinicalTrials.gov (NCT00729183) 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.