Double-blind, partially randomized, parallel group, multicenter study to assess the efficacy and safety of 100 mg and 150 mg monthly oral ibandronate in women with postmenopausal osteoporosis having completed the phase III oral ibandronate trial BM16549
- Conditions
- ong term study in women with postmenopausal osteoporosis.
- Registration Number
- EUCTR2004-001548-60-HU
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 650
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method