NCT00148915
Completed
Phase 4
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis
ConditionsOsteoporosis
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
Overview
Brief Summary
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo Comparator
Participants will receive ibandronate matched placebo tablet orally once monthly for one year.
Intervention: Placebo (Drug)
Ibandronate
Experimental
Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
Intervention: ibandronate (Drug)
Outcomes
Primary Outcomes
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
Time Frame: Year 1
Secondary Outcomes
- Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year(Year 1)
- Hip geometry assessed by cross-sectional dimensions of hip using DXA(Year 1)
- Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans(Year 1)
- Hip geometry assessed by cross-sectional dimensions of hip using vQCT(Year 1)
- Finite element composition of hip and spine to estimate hip and spine strength(Year 1)
- Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality(Year 1)
- Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)(Months 3, 6, 9, and 12)
- Change from baseline for bone-specific alkaline phosphatase (Bone ALP)(Months 3, 6, 9, and 12)
Investigators
Study Sites (1)
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