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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2002

Interventions

  • Drug: alendronate
    • Duration of Treatment : 6 Months

Clinical Trial Outcome Measures

Primary Measures

  • Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

Secondary Measures

  • MK0217 will be safely tolerated

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

Citations Reporting on Results

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.

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