A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)

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. Identifier: NCT00398606
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : May 29, 2013
Information provided by:
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Drug: MK0217, alendronate sodium / Duration of Treatment : 2 Years Drug: Comparator : calcium carbonate /Duration of Treatment : 2 Years Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis in Postmenopausal Women
Study Start Date : April 1995
Actual Primary Completion Date : February 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Osteoporosis

Primary Outcome Measures :
  1. BMD of the lumbar spine determined by a DEXA scan at 2 years

Secondary Outcome Measures :
  1. BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria :

  • Patient is postmenopausal (or surgically menopausal) for at least 5 years.
  • 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

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 identifier (NCT number): NCT00398606

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

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. Identifier: NCT00398606     History of Changes
Other Study ID Numbers: 2006_546
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents