Back to resultsA Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Primary Purpose
Post-Menopausal Osteopenia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ibandronate [Bonviva/Boniva]
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-Menopausal Osteopenia
Eligibility Criteria
Inclusion Criteria:
- post-menopausal women, aged 55-75 years;
- diagnosed osteopenia.
Exclusion Criteria:
- history of osteoporotic vertebral fracture;
- contraindication to ibandronate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Trabecular BV/TV at distal radius of non-dominant arm
Secondary Outcome Measures
Trabecular BV/TV at distal radius of non-dominant arm
Bone density, trabecular BV/TV at distal tibia
Serum CTX
Lumbar hip and wrist BMD
AEs and laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00545207
Brief Title
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Official Title
A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Menopausal Osteopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
150mg po monthly for 2 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po monthly for 2 years
Primary Outcome Measure Information:
Title
Trabecular BV/TV at distal radius of non-dominant arm
Time Frame
12 arms
Secondary Outcome Measure Information:
Title
Trabecular BV/TV at distal radius of non-dominant arm
Time Frame
6 months and 2 years
Title
Bone density, trabecular BV/TV at distal tibia
Time Frame
6 months, 1 and 2 years
Title
Serum CTX
Time Frame
Intervals throughout study
Title
Lumbar hip and wrist BMD
Time Frame
1 and 2 years
Title
AEs and laboratory parameters
Time Frame
Throughout study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post-menopausal women, aged 55-75 years;
diagnosed osteopenia.
Exclusion Criteria:
history of osteoporotic vertebral fracture;
contraindication to ibandronate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Saint-priest En Jarez
ZIP/Postal Code
42277
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
We'll reach out to this number within 24 hrs