A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128257
• Other study ID #: ML22927
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: November 1, 2016
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6054
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 55 years of age

• Postmenopausal osteoporosis

• Patients who are in the opinion of the physician eligible to participate in this study

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• alendronate
As prescribed by physician
• ibandronate [Bonviva/Boniva]
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment		12 months	No
Secondary	Pain intensity and reduction in use of analgesics		12 months	No
Secondary	Quality of life and patients satisfaction		12 months	No
Secondary	Degree of patient's mobility		12 months	No
Secondary	Incidence of new osteoporotic fractures		12 months	No
Secondary	Controllability and management of therapy by the physician		12 months	No
Secondary	Patient baseline characteristics		12 months	No
Secondary	User friendliness		12 months	No
Secondary	Safety: AEs and SAEs		12 months	No