Trial information
BonAdAsia study--A Study of Once Monthly Bonviva (Ibandronate)in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: ML19930
Sponsor: Roche Pharmaceuticals
Company division: Pharmaceutical
Official Scientific Title: A randomized open-label study to investigate the impact of Bone Marker Feedback on adherence to monthly oral Bonviva in women with post-menopausal osteoporosis.
Brief summary: This study will assess the impact of Bone Marker Feedback (BMF) using serum CTX on adherence to monthly Bonviva in women with post-menopausal osteoporosis, and to compare the effect of BMF and no-BMF on efficacy and patient-satisfaction. 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; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. >=83%adherence to treatment
Key secondary outcomes: 1. Efficacy:% change in serum CTX between baseline and 6 months; patient and physician satisfaction (by questionnaire). Safety:SAEs, AEs, fractures
Inclusion criteria:
- women <=85 years of age;
- post-menopausal osteoporosis;
- ambulatory.
Exclusion criteria:
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- history of current or previous cancer;
- administration of any drug which may affect bone mineral density or bone metabolism.
Gender: Females
Age limits: Min: N/A (No limit) Max: 85 Years
Accepts healthy volunteers: No
Trial registration date: 03/16/2006
Date last updated: 8/29/2008
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
