Metastatic bone disease due to breast cancer
Conditions
Interventions
Trade Name: Bondronat 50 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ibandronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Univ. Prof. Dr. Christoph Zielinski
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed informed consent -Female patients >18 years of age with histologically confirmed breast cancer with at least one osteolytic or mixed bone lesion confirmed by X-ray, CT scan or MRI (confirmation within 6 months before screening) -WHO performance status 0, 1 or 2 at screening -Life expectancy > 6 months -Patients must had at least 2 cycles of Zoledronic acid therapy before sreeening -the last dose of Zoledronic acid has to be given >3 weeks prior to start of Ibandronate therapy -Adequate hematology, hepatic and renal function ( =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of brain metastases - Bone surgery within 5 weeks of sreening - High dose chemotherapy (>3x normal intensity) within 6 months - Uncontrolled calcemia (albumin corrected > 2.7mmol/L and < 2.0mmol/L) - Paget’s disease, untreated esophagitis or gastric ulcers - Known hypersensitivity to Ibandronate - Women lactating, pregnant, of childbearing potential or less than one year after menopause (unless surgically sterile) not using a reliable contraceptive method: intrauterine device, mechanical contraception (condom, diaphragm), oral, injectable or implanted contraceptives or total abstinence. Women of childbearing potential must have a negative pregnancy test at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is evidence to suggest that suppression in markers of bone resorption may correlate with a reduction in skeletal related events and metastatic bone pain. Bone markers therefore act as useful determinants for assessing clinical responses to bisphosphonate therapy, which reduces bone resorption. The primary objective is to evaluate the serum levels of biochemical markers of bone turnover in patients with breast cancer and malignant bone disease switched from i.v. Zoledronic acid to oral Ibandronate. ;Secondary Objective: Safety parameters:Serum creatinine, calculated creatinine clerarance;Primary end point(s): The primary objective is to evaluate the serum levels of biochemical markers of bone turnover in patients with breast cancer and malignant bone disease switched from i.v. Zoledronic acid to oral Ibandronate. The change in bone resorption through Ibandronate will be described based on the monitoring of clinical laboratory results of the biochemical markers of bone turnover. The main efficacy endpoint is the stabilization of serum levels of the bone resorption marker s-CTX (cross linked C terminal telopeptide of type I collagen) 3 months after switching to the oral Ibandronate treatment regimen (50mg Ibandronate / day) | — |
Countries
Austria
Outcome results
None listed