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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00545779 |
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.
Condition | Intervention | Phase |
---|---|---|
Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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.' |
Estimated Enrollment: | 650 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months
|
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Albania | |
TIRANA, Albania | |
Bosnia and Herzegovina | |
SARAJEVO, Bosnia and Herzegovina, 71000 | |
TUZLA, Bosnia and Herzegovina, 75000 | |
BANJA LUKA, Bosnia and Herzegovina, 78000 | |
SARAJEVO, Bosnia and Herzegovina, 71 000 | |
Croatia | |
ZAGREB, Croatia, 10000 | |
RIJEKA, Croatia, 51000 | |
SPLIT, Croatia, 21000 | |
SLAVONSKI BROD, Croatia, 35000 | |
Macedonia, The Former Yugoslav Republic of | |
SKOPJE, Macedonia, The Former Yugoslav Republic of, 1000 | |
Serbia | |
NOVI SAD, Serbia, 21000 | |
NISKA BANJA, Serbia, 18250 | |
BELGRADE, Serbia, 11000 | |
Turkey | |
BURSA, Turkey, 16059 | |
ISTANBUL, Turkey, 34300 | |
ISTANBUL, Turkey, 34303 | |
KAYSERI, Turkey, 38039 | |
IZMIR, Turkey, 35100 | |
ISTANBUL, Turkey, 35340 | |
ANTALYA, Turkey, 07070 | |
ADANA, Turkey, 01330 | |
KONYA, Turkey, 42080 | |
AYDIN, Turkey, 09100 | |
TRABZON, Turkey, 61080 | |
DENIZLI, Turkey, 20020 | |
ERZURUM, Turkey, 25240 | |
ANKARA, Turkey, 06550 | |
GAZIANTEP, Turkey, 27310 | |
ANKARA, Turkey, 06100 | |
SAMSUN, Turkey, 55139 | |
MANISA, Turkey, 45200 | |
ISTANBUL, Turkey, 81190 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20430 |
Study First Received: | October 16, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00545779 |
Health Authority: | Turkey: Ministry of Health |
Diphosphonates Ibandronic acid Musculoskeletal Diseases Alendronate Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Menopause |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |