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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148915
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: ibandronate Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year [ Time Frame: Year 1 ]
  2. Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans [ Time Frame: Year 1 ]
  3. Hip geometry assessed by cross-sectional dimensions of hip using vQCT [ Time Frame: Year 1 ]
  4. Finite element composition of hip and spine to estimate hip and spine strength [ Time Frame: Year 1 ]
  5. Hip geometry assessed by cross-sectional dimensions of hip using DXA [ Time Frame: Year 1 ]
  6. Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality [ Time Frame: Year 1 ]
  7. Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX) [ Time Frame: Months 3, 6, 9, and 12 ]
  8. Change from baseline for bone-specific alkaline phosphatase (Bone ALP) [ Time Frame: Months 3, 6, 9, and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148915

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, 33143
GSK Investigational Site
Miami, Florida, United States, 33156
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
Hoffmann-La Roche
Study Director: HoffmannLaRoche Clinical Trials, MD Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00148915     History of Changes
Other Study ID Numbers: BON103593
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Hoffmann-La Roche:

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