Long term study in women with postmenopausal osteoporosis.
Conditions
Interventions
Product Name: Bonviva 150 mg
Product Code: Ro 200-5450/V37
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ibandronic acid
Current Sponsor code: Ro 200-5450
Other descriptive name: Iband
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • patients having completed study BM16549 and who had complied with the monthly regimen for 75% or more • patients must be ambulatory at the beginning of the trial. It must not be anticipated that the patient becomes hospitalized, immobilized or bedridden during the course of the trial • patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration • patients who have provided written informed consent to participate in the study 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
Exclusion criteria
Exclusion criteria: • severe renal failure (calculated GFR < 30 ml/min) • malignant disease diagnosed within the previous 12 years (except successfully resected basal cell cancer), breast cancer diagnosed within the previous 22 years • disease/disorder known to influence bone metabolism • administration of any investigational drug other than ibandornate within 30 days preceding the first dose of the study drug • treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 month, of for more than 2 years (total duration) • treatment with PTH or similar agent for osteoporosis within the last 2 years • treatment with any bisphosphonate other than oral ibandronate since inclusion in BM16549 • treatment with other drugs affecting bone metabolism within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of long-term treatment with monthly oral ibandronate 100 mg and 150 mg, given as a single tablet, on lumbar spine and hip BMD and bone turnover and to assess the overall long-term tolerability and safety of the treatment regimens. ;Secondary Objective: ;Primary end point(s): Lumbar spine (L2-L4) BMD | — |
Countries
Hungary
Outcome results
None listed