A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Condition: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
MeSH terms: Breast Neoplasms
Intervention: Zoledronic Acid; Placebo
Intervention description: 4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.; Matching Placebo
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; premenopausal; Bone Mineral density; Cancer therapy induced bone loss; zoledronic acid

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with histologically confirmed incident invasive breast cancer (T1-4)
             with no evidence of regional lymph node metastasis (N0) or distant metastasis (M0) and
             after complete primary tumor resection and axillary lymph node dissection less than 90
             days before start of study drug treatment.

          -  Hormone receptor status is negative

          -  Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol
             levels (>10ng/dL)

          -  Patient receives adjuvant standard chemotherapy with approved cytotoxic
             chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed)

          -  Bone density at study entry > -2.5 T-Score

        Exclusion Criteria:

          -  Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in
             addition to calcium and vitamin D

          -  Severe physical or psychological concomitant diseases and other known concurrent,
             severe medical disorder jeopardizing the life of the patient in the immediate future
             (e.g., myocardial infarction in previous six months, angina pectoris despite
             treatment, uncontrolled severe arterial hypertension, progressive cardiac or
             respiratory failure)

          -  Known hypersensitivity to bisphosphonates

          -  Abnormal renal function

          -  Current active dental problems including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a current or prior diagnosis of
             osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
             dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g.
             extraction, implants)