A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in
the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will
be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and
calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target
sample size is 100-500 individuals.
Clinical Details
Official title: A Randomized, Double-Blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-Induced Osteoporosis in Post-Menopausal Women
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage change from baseline in mean lumbar spine (L1-L4) BMD
Secondary outcome: Change in mean lumbar spine BMDChange in total hip BMD Change in bone turnover markers Withdrawal rates due to worsening BMD AEs, clinical fractures, laboratory parameters
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- post-menopausal women, 50-85 years of age;
- any inflammatory rheumatoid disease including polymyalgia rheumatica;
- receiving treatment with 5-15 mg/day of prednisolone.
Exclusion Criteria:
- previous treatment with an iv bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
treatment within last year, or >3 months of treatment within last 2 years;
- treatment with parathyroid hormone in last 2 years;
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- history of major gastrointestinal disease.
Locations and Contacts
LAHTI 15110, Finland
HELSINKI 00290, Finland
HELSINKI 00100, Finland
TAMPERE 33100, Finland
TURKU 20100, Finland
OULU 90029, Finland
HYVINKAEAE 05800, Finland
VANTAA 01300, Finland
HAEMEENLINNA 13530, Finland
KUOPIO 70211, Finland
TAMPERE 33101, Finland
JYVAESKYLAE 10100, Finland
JYVAESKYLAE 40100, Finland
OULU 90100, Finland
Additional Information
Starting date: May 2006
Ending date: February 2009
Last updated: June 17, 2008
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