A Phase IIa Randomized, Double-Blind, Placebo Controlled Studyto Evaluate the Effects of Odanacatib (MK-0822) on Bone MineralDensity (BMD) and Overall Safety in the Treatment of Osteoporosisin Postmenopausal Women Previously Treated withAlendronate
Phase 2
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fractureHealth Condition 2: null- Osteoporosis
- Registration Number
- CTRI/2009/091/000218
- Lead Sponsor
- Merck Co Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 247
Inclusion Criteria
Inclusion Criteria:
1. Patient has been postmenopausal for at least 5 years
2. Patient has taken or is taking alendronate
3. Patient agrees not to use medications for osteoporosis other than what is provided by the study
Exclusion Criteria
Exclusion Criteria:
Patient has a history or evidence of hip fracture
Patient has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
Patient has active parathyroid disease
Patient has a history of thyroid disease not adequately controlled by medication
Patient is taking anti-seizure medication and has abnormal calcium metabolism
Patient has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in BMD from baseline at the femoral neck site assessed by DXATimepoint: 24 Months
- Secondary Outcome Measures
Name Time Method Evaluate the effect of treatment on biochemical markers of bone turnover and indices of calcium and mineral homeostasisTimepoint: 24 Months;Percent change in BMD from baseline at the trochanter, total hip, lumbar spine, total body and forearm sites assessed by DXATimepoint: 24 Months