prevention of tumortherapy-induced bone loss MedDRA version: 8.0 Level: LLT Classification code 10049470
Conditions
Interventions
Trade Name: Zometa
Product Name: Zometa
Product Code: CGP42446
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Conce
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the study a patient must fulfill all of the following criteria: · Signed informed consent · Age > 18 years · Performance status 0-2 (ECOG) · Compliant postmenopausal women. Postmenopausal is defined as one of the following: · Age >55 years with cessation of menses. · Age 40 IU/L) or postmenopausal estradiol levels ( 3.0 x 10e9/L, platelets > 100.0 x 10e9/L, and hemoglobin > 10 g/dL) · Adequate hepatic function (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for the study a patient must not fulfill any of the following criteria: · ER and PgR negative or unknown · End of adjuvant Tamoxifen therapy more that 6 months before study beginning · Chemotherapy within the last 12 months before randomization · Inflammatory breast cancer · Abnormal renal function as evidenced by a calculated creatinine clearance 3 months during the past 2 years. · Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization. · Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease-free for five years. · Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded. · Severe physical or psychological concomitant diseases that might impair
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It is the aim of this study to show superiority of Zoledronic acid in prevention of bone loss, administered in combination with Letrozole as extended adjuvant therapy of postmenopausal women with primary hormone receptor positive breast cancer compared to Letrozole alone. Primary efficacy variable: Treatment difference in change in BMD measured by DXA in lumbar spine (L1-L4) at 36 months as compared to baseline.;Secondary Objective: To compare the combined treatment of Letrozole and Zoledronic acid with Letrozole monotherapy with respect to · BMD (measured by DXA at lumbar spine, L1-L4), at 12 months · Fracture rate · Disease free survival (DFS) · Safety and tolerability;Primary end point(s): Treatment difference in change in BMD measured by DXA in lumbar spine (L1-L4) at 36 months as compared to baseline. | — |
Countries
Germany
Outcome results
None listed