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)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00398606

Collaborator

(none)

650

Enrollment

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 1995

Actual Primary Completion Date :

Feb 1, 1998

Outcome Measures

Primary Outcome Measures

BMD of the lumbar spine determined by a DEXA scan at 2 years []

Secondary Outcome Measures

BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years []

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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