Back to resultsA 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)
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217, alendronate sodium / Duration of Treatment : 2 Years
Comparator : calcium carbonate /Duration of Treatment : 2 Years
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00398606
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
February 1998 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
650 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0217, alendronate sodium / Duration of Treatment : 2 Years
Intervention Type
Drug
Intervention Name(s)
Comparator : calcium carbonate /Duration of Treatment : 2 Years
Primary Outcome Measure Information:
Title
BMD of the lumbar spine determined by a DEXA scan at 2 years
Secondary Outcome Measure Information:
Title
BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17594775
Citation
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.
Results Reference
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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)
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