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A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00480662
  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 III

MedlinePlus related topics: Bone Diseases Paget's Disease of Bone
Drug Information available for: Alendronate Alendronate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Merck:

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
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alendronate
    Duration of Treatment : 6 Months
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480662

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:
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. 2008 Jun 7; [Epub ahead of print]
McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_555, MK0217-206
Study First Received: May 30, 2007
Last Updated: September 30, 2008
ClinicalTrials.gov Identifier: NCT00480662  
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Paget's bone disease

Study placed in the following topic categories:
Musculoskeletal Diseases
Alendronate
Osteitis Deformans
 Osteitis
Bone Diseases
Pagets disease

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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