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BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Banja Luka 78000, Bosnia and Herzegovina

Sarajevo 71 000, Bosnia and Herzegovina

Sarajevo 71000, Bosnia and Herzegovina

Tuzla 75000, Bosnia and Herzegovina

Rijeka 51000, Croatia

Slavonski Brod 35000, Croatia

Split 21000, Croatia

Zagreb 10000, Croatia

Belgrade 11000, Serbia

Niska Banja 18250, Serbia

Novi Sad 21000, Serbia

Adana 01330, Turkey

Ankara 06100, Turkey

Ankara 06550, Turkey

Antalya 07070, Turkey

Aydin 09100, Turkey

Bursa 16059, Turkey

Denizli 20020, Turkey

Erzurum 25240, Turkey

Gaziantep 27310, Turkey

Istanbul 81190, Turkey

Istanbul 34300, Turkey

Istanbul 34303, Turkey

Istanbul 35340, Turkey

Izmir 35100, Turkey

Kayseri 38039, Turkey

Konya 42080, Turkey

Manisa 45200, Turkey

Samsun 55139, Turkey

Trabzon 61080, Turkey

Additional Information

Starting date: December 2006
Last updated: January 20, 2014

Page last updated: August 23, 2015

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