A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: ibandronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with osteoporosis BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites Exclusion criteria: Have been treated with other bisphosphonates or using chronic steroids within the past 6 months Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction Have a spine fracture (identified on X-ray)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate<br>Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year. | Drug: ibandronate<br> <br> * Other names: Boniva;|
| Placebo Comparator: Placebo<br>Participants will receive ibandronate matched placebo tablet orally once monthly for one year. | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year |  | 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 | 
| Hip geometry assessed by cross-sectional dimensions of hip using DXA |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, bisphosphonates, bone