Phase 2
Completed N=246
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
Source: ClinicalTrials.gov NCT00885170 ↗Enrolled (actual)
246
Serious AEs
16.5%
Results posted
Apr 2017
Primary outcomePrimary: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 — 1.73; -0.94 Percent Change — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 |
1.73; -0.94 | <0.001 sig |
| PRIMARY Percentage of Participants Experiencing One or More Adverse Events (AEs) |
68.0; 73.6 | — |
| PRIMARY Percentage of Participants Discontinuing Study Drug Due to an AE |
9.0; 3.3 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD at Month 12 |
0.60; -0.28 | 0.166 |
| SECONDARY Percent Change From Baseline in Trochanter BMD at Month 24 |
1.83; -1.35 | 0.002 sig |
| SECONDARY Percent Change From Baseline in Trochanter BMD at Month 12 |
0.86; -0.14 | 0.142 |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 24 |
0.83; -1.87 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 12 |
0.26; -0.80 | 0.023 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 24 |
2.28; -0.30 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 12 |
0.69; -0.12 | 0.103 |
| SECONDARY Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24 |
-0.92; -1.14 | 0.763 |
| SECONDARY Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12 |
-0.11; -0.49 | 0.578 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24 |
93.86; 83.70 | 0.500 |
| SECONDARY Percent Change From Baseline in Log-Transformed s-CTx at Month 12 |
62.27; 68.09 | 0.709 |
| SECONDARY Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24 |
-15.55; 31.48 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12 |
-17.23; 29.06 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24 |
51.62; 40.65 | 0.186 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12 |
30.91; 18.10 | 0.015 sig |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24 |
90.70; 59.53 | 0.011 sig |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12 |
80.37; 56.37 | 0.059 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24 |
-2.40; -2.51 | 0.846 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24 |
2.37; 0.99 | 0.413 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24 |
4.38; 10.28 | 0.326 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24 |
-5.23; -6.71 | 0.835 |
| SECONDARY Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24 |
-2.57; 0.57 | 0.376 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00885170). 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.