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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.


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


Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.


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

Page last updated: August 20, 2015

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