Back to resultsA Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
Primary Purpose
Paget's Disease of Bone
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Paget's Disease of Bone focused on measuring Paget's bone disease
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary Outcome Measures
MK0217 will be safely tolerated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00480662
Brief Title
A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget's Disease of Bone
Keywords
Paget's bone disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alendronate
Other Intervention Name(s)
MK0217
Intervention Description
Duration of Treatment : 6 Months
Primary Outcome Measure Information:
Title
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary Outcome Measure Information:
Title
MK0217 will be safely tolerated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18536953
Citation
Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
We'll reach out to this number within 24 hrs