Breast Cancer Clinical Trial
Official title:
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Bone Biomarkers of Anastrozole When Used to Prevent Breast Cancer in Postmenopausal Women
Verified date | November 2012 |
Source | International Breast Cancer Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital Bern | Bern | |
Switzerland | Oncocare Sonnenhof-Klinik Engeriedspital | Bern |
Lead Sponsor | Collaborator |
---|---|
International Breast Cancer Study Group |
Switzerland,
Singh S, Cuzick J, Edwards R, et al.: Effect of anastrozole on bone mineral density after one year of treatment: results from bone sub-study of the International Breast Cancer Intervention Study (IBIS-II). [Abstract] Breast Cancer Res Treat 106 (1): A-28,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spine and femur bone change comparison | |||
Primary | Effects of bisphosphonate on bone mineral density and bone metabolism in patients who were osteoporotic or moderately severe osteopenic at baseline | |||
Secondary | Correlation of changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density as measured by dual-energy x-ray absorptiometry (DXA) |
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