NCT00480662CompletedPhase 3
A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 60
- Primary Endpoint
- Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Study Overview
Brief Summary
To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease
Exclusion Criteria
- •Patient cannot stand or sit upright for at least 30 minutes
- •Patient has difficulty swallowing or problems with digestive system
Outcomes
Primary Outcomes
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary Outcomes
- MK0217 will be safely tolerated
Investigators
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