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

November 4, 2016 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Upland, California, United States, 91786
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
      • Lakewood, Colorado, United States, 80227
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • GSK Investigational Site
    • Maryland
      • Bathesda, Maryland, United States, 20817
        • GSK Investigational Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • GSK Investigational Site
    • New York
      • West Haverstraw, New York, United States, 10993
        • GSK Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate
Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
Drug: ibandronate
Other Names:
  • Boniva
Placebo Comparator: Placebo
Participants will receive ibandronate matched placebo tablet orally once monthly for one year.
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Year 1
Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
Time Frame: Year 1
Year 1
Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
Time Frame: Year 1
Year 1
Hip geometry assessed by cross-sectional dimensions of hip using vQCT
Time Frame: Year 1
Year 1
Finite element composition of hip and spine to estimate hip and spine strength
Time Frame: Year 1
Year 1
Hip geometry assessed by cross-sectional dimensions of hip using DXA
Time Frame: Year 1
Year 1
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
Time Frame: Year 1
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
Months 3, 6, 9, and 12
Change from baseline for bone-specific alkaline phosphatase (Bone ALP)
Time Frame: Months 3, 6, 9, and 12
Months 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: HoffmannLaRoche Clinical Trials, MD, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BON103593

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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