Trial information
A Study of Adherence to Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP).
Status: No longer recruiting
Protocol number: ML19982
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized open-label study to investigate the impact of Bone Marker Feedback at 3 months on adherence to monthly oral Bonviva in women with post-menopausal osteoporosis supported by a patient relationship program
Brief summary: This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using serum CTX and communication of results at 3 months, on adherence to once monthly Bonviva (150mg po) in women with post-menopausal osteoporosis supported by PRP. Patients will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. 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. 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. Serum CTX levels Time frame: 3 months
3. AEs and laboratory parameters 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 upright for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- treatment with drugs, or presence of active disease, known to influence bone metabolism;
- history of upper gastrointestinal disease.
Gender: Females
Age limits: Min: 55 Years Max: 85 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Hungary
- Békéscsaba
- Budapest
- Debrecen
- Miskolc
- Pecs
- Szeged
- Szekesfehervar
- Szombathely
Latvia
Poland
- Gliwice
- Krakow
- Lodz
- Poznan
- Warszawa
- Wroclaw
Romania
- Bucharest
- Cluj-Napoca
- Constanta
- Craiova
- Timisoara
Russian Federation
- Ekaterinburg
- Irkutsk
- Moscow
- St Petersburg
- Voronezh
- Yaroslavl
Slovakia
- Banska Bystrica
- Bratislava
- Lubochna
- Piestany
- Presov
Slovenia
