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

Hoffmann-La Roche98 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoporosis

Interventions

ibandronateDRUG

PlaceboDRUG

matching placebo

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (14)

GSK Investigational Site

Upland, California, United States

GSK Investigational Site

Boulder, Colorado, United States

GSK Investigational Site

Lakewood, Colorado, United States

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

Time frame: Year 1

Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans

Time frame: Year 1

Hip geometry assessed by cross-sectional dimensions of hip using vQCT

Time frame: Year 1

Finite element composition of hip and spine to estimate hip and spine strength

Time frame: Year 1

Hip geometry assessed by cross-sectional dimensions of hip using DXA

Time frame: Year 1

Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality

Time frame: Year 1

Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)

Time frame: Months 3, 6, 9, and 12

Change from baseline for bone-specific alkaline phosphatase (Bone ALP)

Time frame: Months 3, 6, 9, and 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.