Prevention of cancer treatment-related bone loss in postmenopausal women with ER+ and/or PgR+ breast cancer receiving Letrozole as adjuvant therapy
Conditions
Interventions
Trade Name: Femara 2,5 mg
Product Name: Letrozol
Product Code: FEM345
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Letrozol
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Postmenopausal status Hormone receptor positive ER and/or PgR Patiens with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD Patients with invasive breast cancer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with invasive bilateral breast cancer Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months. Patients with abnormal renal funtion History of diseases with influence on bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the percent in the lumbar spine (L2 to L4) BMD, as measured by dual energy X-ray absorptiometry(DXA), at 12 months in recently postmenopausal and postmenopausal women with hormone receptor positive breast cancer.;Secondary Objective: To describe the percent change in lumbar spine (L2 to L4) BMD at 2 years, 3 years, 4 years and 5 years in the two treatment arms.;Primary end point(s): The primary enpoint is the percent change in the lumbar spine (L2 to L4) regards baseline evaluation | — |
Countries
Spain
Outcome results
None listed