Trial information
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Status: No longer recruiting
Protocol number: ML20882
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the effect on bone mineral density, and the safety, of quarterly intravenous Bonviva in patients with post-menopausal osteoporosis.
Brief summary: This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals. Target sample size is 100.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 1. Mean change (%) in spinal BMD Time frame: 12 months
Key secondary outcomes: 1. Mean change in hip BMD Time frame: 12 months
2. Mean change in Serum CTX Time frame: 6 and 12 months
3. Mean change in hip and spinal BMD Time frame: 6 months
4. AEs and clinical fractures Time frame: Throughout study
5. Percentage change from baseline in OPSAT-Q Time frame: 12 months
Inclusion criteria:
- post-menopausal women with osteoporosis;
- <=80 years of age;
- naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.
Exclusion criteria:
- metabolic bone disease other than post-menopausal osteoporosis;
- treatment with other drugs affecting bone metabolism within last 6 months;
- previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
Gender: Females
Age limits: Min: N/A (No limit) Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 06/27/2007
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Taiwan
- Chai Yi
- Changhua
- Kaohsiung
- Taichung
- Tainan
- Taipei
- Taoyuan
