Trial information
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Status: No longer recruiting
Protocol number: ML20088
Sponsor: Hoffmann-La Roche; Glaxo Smithkline
Company division: Pharmaceutical
Official Scientific 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
Brief 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. Target sample size is
150.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 1. Percentage change from baseline in mean lumbar spine (L1-L4) BMD Time frame: 12 months
Key secondary outcomes: 1. Change in mean lumbar spine BMD Time frame: 6 months
2. Change in total hip BMD Time frame: 6 and 12 months
3. Change in bone turnover markers Time frame: 1, 6 and 12 months
4. Withdrawal rates due to worsening BMD Time frame: 6 months
5. AEs, clinical fractures, laboratory parameters Time frame: Throughout study
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.
Gender: Females
Age limits: Min: 50 Years Max: 85 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 07/19/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Finland
- Haemeenlinna
- Helsinki
- Hyvinkaeae
- Jyvaeskylae
- Kuopio
- Lahti
- Oulu
- Tampere
- Turku
- Vantaa
