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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.

PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

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