Status:
WITHDRAWN
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
Lead Sponsor:
ETOP IBCSG Partners Foundation
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
40-70 years
Phase:
PHASE3
Brief 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 m...
Detailed Description
OBJECTIVES: Primary * Compare the changes in bone of the spine and femur in postmenopausal women with ductal carcinoma in situ treated with anastrozole vs placebo on protocol CRUK-IBIS-II-DCIS. * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00324714
Start Date
February 1 2003
Last Update
November 29 2012
Active Locations (2)
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1
Inselspital Bern
Bern, Switzerland, CH-3010
2
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, Switzerland, CH-3012