A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00148915
First received: September 6, 2005
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.


Condition Intervention Phase
Osteoporosis
Drug: ibandronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A One Year, Parallel, Placebo-Controlled, Double-Blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year. [ Time Frame: 1 Year ]

Secondary Outcome Measures:
  • Relationship between biomarkers and changes in bone quality for one year. [ Time Frame: 1 Year ]

Enrollment: 100
Study Start Date: August 2005
Intervention Details:
    Drug: ibandronate
    Other Name: ibandronate
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
  • Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole.

Exclusion criteria:

  • Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
  • Have a history of major upper GI diseases or have severe kidney dysfunction.
  • Have a spine fracture (identified on x-ray).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148915

Locations
United States, California
GSK Investigational Site
Upland, California, United States, 91786
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Lakewood, Colorado, United States, 80227
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maine
GSK Investigational Site
Bangor, Maine, United States, 04401
United States, Maryland
GSK Investigational Site
Bathesda, Maryland, United States, 20817
United States, Michigan
GSK Investigational Site
Flint, Michigan, United States, 48532
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
GSK Investigational Site
West Haverstraw, New York, United States, 10993
United States, Pennsylvania
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00148915     History of Changes
Other Study ID Numbers: BON103593
Study First Received: September 6, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Osteoporosis
bisphosphonates
bone

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014