Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer

1. Required Characteristics

   1. Premenopausal women

      * ≤ 6 months since last menstrual period
      * no prior bilateral oophorectomy
      * not on estrogen replacement therapy
      * if TAH is performed, with at least one intact ovary, or if \> 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry
   2. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)
   3. ≥ 18 years of age
   4. ECOG performance status (PS) 0 or 1
2. Contraindications

   1. Hypercalcemia (calcium level \> 1mg/dL above UNL ≤ 6 months
   2. Hypocalcemia (calcium level \> 0.5 mg/dL below UNL ≤ 6 months
   3. Inability to stand or sit upright for at least 30 minutes
   4. Known swallowing disorder
   5. Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine

      * a patient with a T score of - 2.1 is ineligible
      * a patient with a T score of - 1.9 is eligible
   6. History of vertebral compression fracture

      * Exception: traumatic fracture of the coccyx would not exclude a patient from participation
   7. Corticosteroids at doses \> 5 mg daily of prednison or equivalent for \> 2 weeks in the past 6 months
   8. Previous treatment with bisphosphonates
   9. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
   10. History of severe renal impairment or creatinine \> 2.0 mg/dL
   11. Malabsorption syndrome
   12. Estrogen replacement therapy
   13. Oral contraceptive use
   14. Prior bilateral oophorectomy
   15. Pregnant women

       * Nursing women
       * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.)
       * This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
   16. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment