Status:
COMPLETED
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Osteoporosis
Eligibility:
FEMALE
55-80 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00148915
Start Date
August 1 2005
End Date
August 1 2007
Last Update
November 8 2016
Active Locations (14)
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1
GSK Investigational Site
Upland, California, United States, 91786
2
GSK Investigational Site
Boulder, Colorado, United States, 80304
3
GSK Investigational Site
Lakewood, Colorado, United States, 80227
4
GSK Investigational Site
Miami, Florida, United States, 33143