A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis - Full Text View

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 III

MedlinePlus related topics:

Dietary Supplements Osteoporosis

ChemIDplus related topics:

Alendronate Alendronate sodium Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Estimated Enrollment:	720
Study Start Date:	September 2003

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

Locations


United States, Pennsylvania
	Call for Information
	Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

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.

Study ID Numbers:	2004_021
First Received:	September 21, 2004
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00092079
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vitamin D Deficiency

Cholecalciferol

Avitaminosis

Ergocalciferols

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Malnutrition

Vitamin D

Musculoskeletal Diseases

Alendronate

Nutrition Disorders

Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances

Vitamins

Physiological Effects of Drugs

Bone Density Conservation Agents

Micronutrients

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 09, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092079