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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02553850

Enrollment

442

Registered

2015-09-18

Start date

2007-04-30

Completion date

2010-01-31

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of patients who died due to progression of breast cancer	12 months
Safety: Incidence of adverse events	12 months

Countries

Hungary

Outcome results