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

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: ibandronate; Drug: Placebo

• Registration Number: NCT00148915
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibandronate	ibandronate	Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
Placebo	Placebo	Participants will receive ibandronate matched placebo tablet orally once monthly for one year.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Duncansville, Pennsylvania, United States