An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)

October 29, 2016 updated by: Hoffmann-La Roche

A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT

This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

442

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

  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1441
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9023
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Nyíregyháza, Hungary, 4400
      • Pecs, Hungary, 7623
      • Szeged, Hungary, 6725
      • Szeged, Hungary, 6720
      • Szekesfehervar, Hungary, 8000
      • Szekszard, Hungary, 7100
      • Szolnok, Hungary, 5004
      • Szombathely, Hungary, 9700
      • Tatabánya, Hungary, 2800
      • Veszprem, Hungary, 8200
      • Zalaegerszeg-Pozva, Hungary, 8900

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with breast cancer and bone metastases who have been prescribed ibandronate (Bondronat) will be evaluated in the routine oncological setting for 12 months.

Description

Inclusion Criteria:

  • All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
  • Adult patients greater than (>) 18 years of age
  • Histologically confirmed breast cancer
  • Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
  • Life expectancy >6 months
  • No previous bisphosphonate therapy
  • Patients signed written informed consent form before study start

Exclusion Criteria:

  • All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
  • Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
  • Hypersensitivity to bisphosphonates

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
Ibandronate
Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beta C-terminal telopeptide (B-CTx) level
Time Frame: 12 months
12 months
Treatment response rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 12 months
12 months
Number of patients who died due to progression of breast cancer
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, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20416

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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