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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: Placebo (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage change from baseline in mean lumbar spine (L1-L4) BMD

Secondary outcome:

Change in mean lumbar spine BMD

Change 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

Helsinki 00100, Finland

Helsinki 00290, Finland

Helsinki 00350, Finland

Hyvinkää 05800, Finland

Hämeenlinna 13530, Finland

Jyvaeskylae 10100, Finland

Jyväskylä 40100, Finland

Kuopio 70211, Finland

Lahti 15110, Finland

Oulu 90029, Finland

Oulu 90100, Finland

Tampere 33100, Finland

Tampere 33101, Finland

Turku 20100, Finland

Vantaa 01300, Finland

Additional Information

Starting date: May 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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