Back to resultsA Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217, alendronate sodium/Duration of Treatment: 6 months
Comparator: placebo / Duration of Treatment: 6 months
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria: Women with postmenopausal osteoporosis Exclusion Criteria: High risk for fractures Esophageal abnormalities Upper gastrointestinal symptoms that are not relieved with medication Metabolic bone disease (example - vitamin D deficiency) Medications that would affect the breakdown or build-up of bone
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
Secondary Outcome Measures
To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092027
Brief Title
A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
Official Title
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for 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
March 19, 2003 (Actual)
Primary Completion Date
March 15, 2004 (Actual)
Study Completion Date
March 15, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
454 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0217, alendronate sodium/Duration of Treatment: 6 months
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo / Duration of Treatment: 6 months
Primary Outcome Measure Information:
Title
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
Secondary Outcome Measure Information:
Title
To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
Title
To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with postmenopausal osteoporosis
Exclusion Criteria:
High risk for fractures
Esophageal abnormalities
Upper gastrointestinal symptoms that are not relieved with medication
Metabolic bone disease (example - vitamin D deficiency)
Medications that would affect the breakdown or build-up of bone
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
16257815
Citation
Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
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