Trial information
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Status: Completed
Protocol number: ML19937
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, clinical observation extension study to assess continuing safety and adherence in patients with postmenopausal osteoporosis receiving monthly oral Bonviva
Brief summary: This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is
626.
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. SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms Time frame: Throughout study
Key secondary outcomes: 1. N/A Time frame: N/A
Inclusion criteria:
- patients responding to oral monthly Bonviva during the BonAdAsia study;
- willing to continue Bonviva treatment for a further 6 months.
Exclusion criteria:
Gender: Females
Age limits: Min: N/A (No limit) Max: 85 Years
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
China
Indonesia
- Jakarta
- Makassar
- Surabaya
Philippines
Taiwan
- Changhua
- Taichung
- Tainan
- Taipei
- Taoyuan
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
