A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00480662
• Collaborator: (none)
• Enrollment: 60
• Duration (Months): 12

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paget's Disease of Bone	Drug: alendronate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2001
• Actual Primary Completion Date: Oct 1, 2002
• Actual Study Completion Date: Oct 1, 2002

Outcome Measures

Primary Outcome Measures

1. Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months []

Secondary Outcome Measures

1. MK0217 will be safely tolerated []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00480662
• Other Study ID Numbers: 0217-206; MK0217-206; 2007_555
• First Posted: May 31, 2007
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Paget's bone disease
• Additional relevant MeSH terms: Bone Diseases; Osteitis Deformans; Alendronate

Study Results

No Results Posted as of Feb 3, 2022