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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00480662

First received: May 30, 2007

Last updated: September 30, 2008

Last verified: September 2008

History of Changes

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:

Genetics Home Reference related topics: inclusion body myopathy with early-onset Paget disease and frontotemporal dementia juvenile Paget disease Paget disease of bone

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

Drug Information available for: Alendronate sodium

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:

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:

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

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:	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 May 23, 2013

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