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)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Postmenopausal
Intervention: MK0217, alendronate sodium / Duration of Treatment : 2 Years (Drug); Comparator : calcium carbonate /Duration of Treatment : 2 Years (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: BMD of the lumbar spine determined by a DEXA scan at 2 years
Secondary outcome: BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: Bonnick S, Broy S, Kaiser F, Teutsch C, Rosenberg E, DeLucca P, Melton M. Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density. Curr Med Res Opin. 2007 Jun;23(6):1341-9.
Starting date: April 1995
Last updated: May 28, 2013
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