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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389740
First Posted: October 19, 2006
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date: April 2, 2001
Study Completion Date: January 16, 2003
Primary Completion Date: January 16, 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389740


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00389740     History of Changes
Other Study ID Numbers: 0217-189
2006_537
First Submitted: October 18, 2006
First Posted: October 19, 2006
Last Update Posted: June 8, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
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