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Trial record 6 of 15 for:    "Paget disease of bone"

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

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ClinicalTrials.gov Identifier: NCT00480662
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 Type : Interventional  (Clinical Trial)
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 : October 2001
Primary Completion Date : October 2002
Study Completion Date : October 2002

Intervention Details:
    Drug: alendronate
    Duration of Treatment : 6 Months
    Other Name: MK0217

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480662

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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00480662     History of Changes
Other Study ID Numbers: 0217-206
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

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

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