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

Post-Menopausal Osteoporosis Clinical Trial

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.'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545779
• Other study ID #: ML20430
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: January 20, 2014
• Start date: December 2006
• Est. completion date: July 2010

Study information

• Verified date: January 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-Menopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Albania,  Bosnia and Herzegovina,  Croatia,  Serbia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate		6 months	No
Secondary	Improved satisfaction scores with Bonviva		6 months	No
Secondary	>=80% compliance with Bonviva		6 months	No
Secondary	Choice of monthly reminders to take Bonviva		6 months	No
Secondary	Improvement in GI symptoms		6 months	No