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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6054

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female post-menopausal patients over the age of 55 years

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Drug: ibandronate [Bonviva/Boniva]
As prescribed by physician
2
Drug: alendronate
As prescribed by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity and reduction in use of analgesics
Time Frame: 12 months
12 months
Quality of life and patients satisfaction
Time Frame: 12 months
12 months
Degree of patient's mobility
Time Frame: 12 months
12 months
Incidence of new osteoporotic fractures
Time Frame: 12 months
12 months
Controllability and management of therapy by the physician
Time Frame: 12 months
12 months
Patient baseline characteristics
Time Frame: 12 months
12 months
User friendliness
Time Frame: 12 months
12 months
Safety: AEs and SAEs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22927

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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