Trial information
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
Status: No longer recruiting
Protocol number: ML20430
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 'An open-label study of patient preference with monthly Bonviva therapy in women with post-menopausal osteoporosis switched from daily or weekly alendronate or risendronate.'
Brief summary: This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 650.
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. Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate Time frame: 6 months
Key secondary outcomes: 1. Improved satisfaction scores with Bonviva Time frame: 6 months
2. >=80% compliance with Bonviva Time frame: 6 months
3. Choice of monthly reminders to take Bonviva Time frame: 6 months
4. Improvement in GI symptoms Time frame: 6 months
Inclusion criteria:
- post-menopausal women;
- >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
Exclusion criteria:
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone metabolism;
- abnormalities of the oesophagus, which delay oesophageal emptying.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2006
Trial registration date: 10/17/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Albania
Bosnia and Herzegovina
- Banja Luka
- Sarajevo
- Tuzla
Croatia
- Rijeka
- Slavonski Brod
- Split
- Zagreb
Macedonia, The Former Yugoslav Republic of
Turkey
- Adana
- Ankara
- Antalya
- Aydin
- Bursa
- Denizli
- Erzurum
- Gaziantep
- Istanbul
- Izmir
- Kayseri
- Konya
- Manisa
- Samsun
- Trabzon
