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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545051
• Other study ID #: ML20088
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: March 1, 2016
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health/ETENE
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Placebo
po monthly for 12 months
• ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in mean lumbar spine (L1-L4) BMD		12 months	No
Secondary	Change in mean lumbar spine BMD		6 months	No
Secondary	Change in total hip BMD		6 and 12 months	No
Secondary	Change in bone turnover markers		1, 6 and 12 months	No
Secondary	Withdrawal rates due to worsening BMD		6 months	No
Secondary	AEs, clinical fractures, laboratory parameters		Throughout study	No