A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00092079

First received: September 21, 2004

Last updated: May 28, 2013

Last verified: May 2013

History of Changes

Purpose

The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.

Condition	Intervention	Phase
Osteoporosis Vitamin D Deficiency	Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Alendronate sodium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria

Estimated Enrollment:	720
Study Start Date:	September 2003
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or postmenopausal women who are osteoporotic

Exclusion Criteria:

Vitamin D deficiency
Other disease of bone or mineral metabolism
Digestive disease causing malabsorption
Other medical conditions that are not adequately treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092079

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitior

Merck

More Information

Publications:

Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55.

Binkley N, Ringe JD, Reed JI, Ljunggren O, Holick MF, Minne HW, Liu M, Lamotta A, West JA, Santora AC. Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. Bone. 2009 Apr;44(4):639-47. Epub 2008 May 15.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092079 History of Changes
Other Study ID Numbers:	2004_021, MK0217A-227
Study First Received:	September 21, 2004
Last Updated:	May 28, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

Cholecalciferol
Alendronate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 13, 2013

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