A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease - Full Text View

Sponsor:	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

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:

MedlinePlus related topics: Bone Diseases Paget's Disease of Bone

Drug Information available for: Alendronate Alendronate sodium Fosamax

U.S. FDA Resources

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:

Enrollment:	60
Study Start Date:	October 2001
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment : 6 Months

Other Name: MK0217

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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:

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

Keywords provided by Merck:

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 February 12, 2012