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A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 18, 2006
Last updated: January 27, 2017
Last verified: January 2017
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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: April 2001
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00389740

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00389740     History of Changes
Other Study ID Numbers: 0217-189
Study First Received: October 18, 2006
Last Updated: January 27, 2017

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Raloxifene Hydrochloride
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators processed this record on April 26, 2017