Randomized, double-blind, double-dummy, parallel group, multicenter study to compare the efficacy and safety of once-monthly oral administration of 150 mg ibandronate with once-weekly oral administration of 70 mg alendronate in postmenopausal osteoporosis - Non-inferiority trial
- Conditions
- Study in women with postmenopausal osteoporosis.
- Registration Number
- EUCTR2004-002255-14-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1786
- Women, at least five years after menopause
- Age 55 to 84 years
- -5.0 SD =Mean lumbar spine BMD (L2-L4) T-score < -2.5 SD
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Inability to stand or sit upright for 60 mn
- Hypersensitivity to bisphosphonates and to any of their components
- Contra-indications for calcium or vitamin D therapy
- Vitamin D deficiency (serum 25-hydroxy vitamin D < 16ng/ml, equivalent to 40 nmol/l)
- Renal impairment (creatinine clearance< 35 mL/min, using Cockroft and gault equation)
- History of major upper GI disease
- Malignant disease diagnosed within the previous 10 years(except successfully resected basal cell cancer), breast cancer diagnosed within the previous 20 years
- Active disease/disorder known to influence bone metabolism
- Previous treatment with other drugs affecting bone metabolism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method