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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: ibandronate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
HoffmannLaRoche Clinical Trials, MD, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year

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

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

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

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

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

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

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

Eligibility

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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 and Contacts

GSK Investigational Site, Upland, California 91786, United States

GSK Investigational Site, Boulder, Colorado 80304, United States

GSK Investigational Site, Lakewood, Colorado 80227, United States

GSK Investigational Site, Miami, Florida 33143, United States

GSK Investigational Site, Miami, Florida 33156, United States

GSK Investigational Site, Atlanta, Georgia 30308, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Indianapolis, Indiana 46202, United States

GSK Investigational Site, Bangor, Maine 04401, United States

GSK Investigational Site, Bathesda, Maryland 20817, United States

GSK Investigational Site, Flint, Michigan 48532, United States

GSK Investigational Site, Albuquerque, New Mexico 87106, United States

GSK Investigational Site, West Haverstraw, New York 10993, United States

GSK Investigational Site, Duncansville, Pennsylvania 16635, United States

Additional Information

Starting date: August 2005
Last updated: July 20, 2015

Page last updated: August 23, 2015

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