Status: No longer recruiting
Official 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.
Study Phase: 4
Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition:
Post-Menopausal Osteoporosis
Intervention Type: Drug
Intervention Name: ibandronate [Bonviva/Boniva]
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.
This trial will be conducted at the following locations:
Albania
Serbia
- BELGRADE 11000
- BELGRADE
- NISKA BANJA
- NOVI SAD
Turkey
- BURSA 16059
- ISTANBUL
- ISTANBUL
- ISTANBUL
- IZMIR
- ISTANBUL
- ANTALYA
- ADANA
- KONYA
- AYDIN
- TRABZON
- DENIZLI
- ERZURUM
- ANKARA
- GAZIANTEP
- ANKARA
- SAMSUN
- MANISA
- KAYSERI
- ANKARA
Bosnia and Herzegovina
- SARAJEVO 71000
- TUZLA
- BANJA LUKA
- SARAJEVO
Croatia
- ZAGREB 10000
- ZAGREB
- ZAGREB
- ZAGREB
- RIJEKA
- SPLIT
- SLAVONSKI BROD
Macedonia
- SKOPJE 1000
- SKOPJE
- SKOPJE