BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
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.'
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate
Secondary outcome: Improved satisfaction scores with Bonviva>=80% compliance with Bonviva Choice of monthly reminders to take Bonviva Improvement in GI symptoms
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
TIRANA, Albania
SARAJEVO 71000, Bosnia and Herzegovina
TUZLA 75000, Bosnia and Herzegovina
BANJA LUKA 78000, Bosnia and Herzegovina
SARAJEVO 71 000, Bosnia and Herzegovina
ZAGREB 10000, Croatia
RIJEKA 51000, Croatia
SPLIT 21000, Croatia
SLAVONSKI BROD 35000, Croatia
SKOPJE 1000, Macedonia, The Former Yugoslav Republic of
BELGRADE 11000, Serbia
NISKA BANJA 18250, Serbia
NOVI SAD 21000, Serbia
BURSA 16059, Turkey
ISTANBUL 34300, Turkey
ISTANBUL 34303, Turkey
ISTANBUL 81190, Turkey
IZMIR 35100, Turkey
ISTANBUL 35340, Turkey
ANTALYA 07070, Turkey
ADANA 01330, Turkey
KONYA 42080, Turkey
AYDIN 09100, Turkey
TRABZON 61080, Turkey
DENIZLI 20020, Turkey
ERZURUM 25240, Turkey
ANKARA 06550, Turkey
GAZIANTEP 27310, Turkey
ANKARA 06100, Turkey
SAMSUN 55139, Turkey
MANISA 45200, Turkey
KAYSERI 38039, Turkey
Additional Information
Starting date: December 2006
Ending date: July 2008
Last updated: June 17, 2008
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