A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis

This study has been completed.

First Received on September 21, 2004. Last Updated on January 21, 2010 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092066

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 the treatment of osteoporosis in men and postmenopausal women.

Condition	Intervention	Phase
Osteoporosis Vitamin D Deficiency	Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks	Phase III

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:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Dietary Supplements Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Alendronate Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.

Secondary Outcome Measures:

Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.

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 significant medical conditions that are not adequately treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092066

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

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:	NCT00092066 History of Changes
Other Study ID Numbers:	2004_020, MK0217A-227
Study First Received:	September 21, 2004
Last Updated:	January 21, 2010
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 February 09, 2012