At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal for 5 or more years (no menses for ≥5 years or ≥5 years post-bilateral oophorectomy)
- ✓Bone mineral density T-score at hip or spine of -2.0 or less
- ✓Suitable lumbar spine anatomy for DXA with no vertebral fractures in at least 3 vertebrae in L1-L4 region
- ✓At least one hip evaluable by DXA with no hardware from orthopedic procedures
- ✕History of prior osteoporotic fracture (unless declined treatment or ineligible for osteoporosis therapy)
- ✕Past treatment with osteoporosis medications, steroids, hormone replacement, or other bone-active drugs (specific washout periods vary by drug class)
- ✕Any prior use of intravenous bisphosphonates is not permitted
- ✕Significant clinical or laboratory abnormalities at screening or non-ambulatory status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin K Inhibitor) in the Treatment of Postmenopausal Women With Osteoporosis
In Brief
A Phase 2 clinical trial evaluating Odanacatib, Vitamin D3, and 2 other interventions for Osteoporosis. Completed, enrolled 399 participants.
Detailed Summary
This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib \[MK-0822\]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).
Study Details
Timeline
Interventions
Odanacatib 3 mg, once weekly for 24 months
Odanacatib 10 mg, once weekly for 24 months
Odanacatib 25 mg, once weekly for 24 months
Odanacatib 50 mg, once weekly for 24 months
Vitamin D3, two 2800 IU weekly throughout the study
Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months