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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148915
• Other study ID #: BON103593
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: November 4, 2016
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• ibandronate

• Placebo
matching placebo

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Bathesda	Maryland
United States	GSK Investigational Site	Boulder	Colorado
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Upland	California
United States	GSK Investigational Site	West Haverstraw	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year		Year 1	No
Secondary	Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans		Year 1	No
Secondary	Hip geometry assessed by cross-sectional dimensions of hip using vQCT		Year 1	No
Secondary	Finite element composition of hip and spine to estimate hip and spine strength		Year 1	No
Secondary	Hip geometry assessed by cross-sectional dimensions of hip using DXA		Year 1	No
Secondary	Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality		Year 1	No
Secondary	Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)		Months 3, 6, 9, and 12	No
Secondary	Change from baseline for bone-specific alkaline phosphatase (Bone ALP)		Months 3, 6, 9, and 12	No