Risedronate in Improving Bone Mineral Density and Bone Health in Postmenopausal Women With Ductal Carcinoma In Situ Enrolled in Clinical Trial CRUK-IBIS-II-DCIS

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying risedronate to see how well it works compared to a placebo in improving bone mineral density and bone health in postmenopausal women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK: Cancer Research UK) (DCIS: Ductal carcinoma in situ).

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

Details

• Lead Sponsor: International Breast Cancer Study Group
• Treatments: Risedronate Sodium; Risedronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of ductal carcinoma in situ within the past 6 months

• Locally excised with tumor-free margins at least 1 mm

• Currently enrolled in protocol CRUK-IBIS-II-DCIS AND randomized to receive either anastrozole or placebo

• No T-score < -4.0 and/or > 2 low trauma vertebral fractures by dual-energy x-ray absorptiometry (DXA)

• Hormone receptor status: Estrogen or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

• Female patient

• Postmenopausal

• No prior bilateral hip fracture or bilateral hip prostheses

• No concurrent metabolic bone disease, including any of the following:

• Paget's disease

• Osteogenesis imperfecta

• Disorders of calcium or mineral metabolism

• Renal calculus

• Malabsorption

• Hypercalcemia or hypocalcemia

• Hyperparathyroidism or hypoparathyroidism

• Hyperthyroidism or hypothyroidism

• Patients on stable replacement therapy are allowed provided they are euthyroid

PRIOR CONCURRENT THERAPY:

• More than 12 months since prior medication affecting bone metabolism, including any of the following:

• Estrogen

• Any bisphosphonate

• Parathyroid hormone

• Calcitonin

• Oral or systemic glucocorticoids