Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2011
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00885170
Start Date
April 13 2009
End Date
September 15 2011
Last Update
August 28 2018
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