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)
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
2 other identifiers
interventional
650
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 10, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedFebruary 3, 2022
February 1, 2022
2.8 years
November 10, 2006
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
BMD of the lumbar spine determined by a DEXA scan at 2 years
Secondary Outcomes (1)
BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
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. doi: 10.1185/030079907X188035.
PMID: 17594775BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2006
First Posted
November 14, 2006
Study Start
April 1, 1995
Primary Completion
February 1, 1998
Last Updated
February 3, 2022
Record last verified: 2022-02