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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00148915
First received: September 6, 2005
Last updated: July 20, 2015
Last verified: July 2015

September 6, 2005
July 20, 2015
August 2005
August 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00148915 on ClinicalTrials.gov Archive Site
  • Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Hip geometry assessed by cross-sectional dimensions of hip using vQCT [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Finite element composition of hip and spine to estimate hip and spine strength [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Hip geometry assessed by cross-sectional dimensions of hip using DXA [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX) [ Time Frame: Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Change from baseline for bone-specific alkaline phosphatase (Bone ALP) [ Time Frame: Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
Relationship between biomarkers and changes in bone quality.
Not Provided
Not Provided
 
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
Drug: ibandronate
Other Name: Boniva
  • Experimental: Ibandronate
    Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
    Intervention: Drug: ibandronate
  • Placebo Comparator: Placebo
    Participants will receive ibandronate matched placebo tablet orally once monthly for one year.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
August 2007
August 2007   (final data collection date for primary outcome measure)

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)
Female
55 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148915
BON103593
Yes
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: HoffmannLaRoche Clinical Trials, MD Hoffmann-La Roche
Hoffmann-La Roche
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP