Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2011
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00729183
Start Date
October 2 2008
End Date
March 21 2011
Last Update
August 27 2018
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