Conditions: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
Keywords: Breast Cancer premenopausal Bone Mineral density Cancer therapy induced bone loss zoledronic acid
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover.

This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.

This study is not recruiting patients in the United States.

Detailed description:

Arms:
arm 1: Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months. arm 2: Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials. intervention 2: Matching Placebo

Protocol document: