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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

September 6, 2005
October 15, 2008
August 2005
Not Provided
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 ]
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
Relationship between biomarkers and changes in bone quality for one year. [ Time Frame: 1 Year ]
Relationship between biomarkers and changes in bone quality.
Not Provided
Not Provided
 
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoporosis
Drug: ibandronate
Other Name: ibandronate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
Not Provided

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).
Female
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148915
BON103593
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

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