Trial information
ATOM study:A Study of Adherence to Bonviva (Ibandronate)Once Monthly in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: ML19324
Sponsor: Roche Norge AS; Glaxo Smithkline
Company division: Pharmaceutical
Official Scientific Title: A randomized open-label study to investigate factors affecting adherence to monthly oral Bonviva in women with post-menopausal osteoporosis
Brief summary: This study will validate different methods of supporting patients to take their monthly dose of Bonviva (150mg po). Patients will be randomized into one of 4 groups providing a) a calendar sticker b)letter from doctor in addition to sticker c) telephone message in addition to sticker d) electronic supporting device in addition to sticker, and compliance to medication will be measured. The anticipated time on treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 180.
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. Mean difference from target dosing day for each treatment
Key secondary outcomes: 1. Compliance: No. of non-compliant patients in each group; patient satisfaction with supporting methods; preference of monthly or daily dosing. Safety: AEs.
Inclusion criteria:
- ambulatory, post-menopausal(>5 years)women with osteoporosis;
- >55 years of age;
- suitable for treatment with bisphosphonates.
Exclusion criteria:
- inability to stand or sit upright for 60 minutes;
- hypersensitivity to bisphosphonates;
- history of major upper gastrointestinal disease.
Gender: Females
Age limits: Min: 55 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Norway
- Bøverbru
- Elverum
- Fevik
- Gjovik
- Kongsberg
- Kristiansand
- Lena
- Oslo
- Svelvik
- Ulset
