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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
Matching Placebo
Novartis Investigative Site
Marburg, Germany
Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.
Time frame: 24 months
Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months
Time frame: 2 years
Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)
Time frame: 2 years
Pathologic Fractures During 24 Month
Time frame: 2 years
Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months
Time frame: 2 years
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