A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis

This study has been completed.

First Received: October 18, 2006 Last Updated: September 30, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00389740

Purpose

The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: MK0217, /Duration of Treatment : 12 Months Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Alendronate Raloxifene hydrochloride Raloxifene Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Bone Mineral Density (BMD) in PA lumbar spine at 12 months

Secondary Outcome Measures:

Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months

Enrollment:	400
Study Start Date:	February 2001
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is postmenopausal (or surgically menopausal) for at least 6 months
Patient must be diagnosed with osteoporosis
Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria:

Patient is receiving or has received treatment prior to randomization which might influence bone turnover
Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389740

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_537
Study First Received:	October 18, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00389740 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators

Bone Diseases
Hormones
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators

Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on July 02, 2009