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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00480662
First received: May 30, 2007
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 60
Study Start Date: October 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alendronate
    Duration of Treatment : 6 Months
    Other Name: MK0217
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480662

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00480662     History of Changes
Other Study ID Numbers: 0217-206, MK0217-206, 2007_555
Study First Received: May 30, 2007
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Paget's bone disease

Additional relevant MeSH terms:
Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014