Study in women with postmenopausal osteoporosis.
Conditions
Interventions
Product Name: Bonviva 150 mg Film-coated tablet
Product Code: Ro 200-5450/V37
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ibandronic acid
Current Sponsor code: Ro 200-5450
Other descr
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women, at least five years after menopause - Age 55 to 84 years - -5.0 SD =Mean lumbar spine BMD (L2-L4) T-score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of lumbar spine and total hip BMD changes using once-monthly oral ibandronate 150 mg, versus once-weekly oral alendronate 70 mg and also to assess the tolerability and safety of ibandronate versus alendronate.;Secondary Objective: ;Primary end point(s): Relative change (%) from baseline in mean lumbar spine (L2-L4) BMD at 12 months. Relative change (%) from baseline in total hip BMD at 12 months. | — |
Countries
Czech Republic, Germany, Hungary, Spain, United Kingdom
Outcome results
None listed