Trial information
BEATRIS study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women with Post-Menopausal Osteoporosis
Status: Completed
Protocol number: ML19913
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomised, open label study to investigate the impact of Bone Marker Feedback at 2 months on adherence to monthly oral Bonviva (ibandronate) in women with post-menopausal osteoporosis.
Brief summary: This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is
600.
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. Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group Time frame: 6 months
Key secondary outcomes: 1. Patient satisfaction by OPSAT-Q and OPPS. Time frame: 6 months
2. Tolerability; SAEs. Time frame: Throughout study
Inclusion criteria:
- ambulatory post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
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;
- administration of any drug, or presence of active disease, known to influence bone metabolism;
- uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
- history of major upper gastrointestinal disease.
Gender: Females
Age limits: Min: 55 Years Max: 85 Years
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Austria
- Bregenz
- Graz
- Innsbruck
- Linz
- Salzburg
- Vöcklabruck
- Wien
Belgium
- Aalst
- Antwerpen
- Braine L'Alleud
- Brugge
- Bruxelles
- Charleroi
- Dinant
- Ekeren
- Genk
- Gent
- Godinne
- Hasselt
- Kortrijk
- Liege
- Merksem
- Mons
- Oostende
- Roeselare
- Sijsele
- Tournai
- Waremme
- Wilrijk
Greece
- Athens
- Kifissia
- Larissa
- Thessaloniki
Ireland
