Status:
COMPLETED
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Breast Cancer
Menopause
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures. Thi...
Eligibility Criteria
Inclusion
- Postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
- Operated for an invasive breast cancer (histologically proven)
- Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
- Treated with aromatase inhibitor
- Osteopenic (-2.5\<T score\<-1) without osteoporotic fracture
- With written informed consent signed
- With social security
Exclusion
- Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at least one measure site
- Women presenting clinical signs of metastases
- Having received other hormonal treatment in the last 3 months
- Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
- Presenting a known and untreated hyperthyroid
- Presenting a known hyperadrenocorticism
- Patients treated and followed for Paget's disease of bone
- Presenting a untreated primary hyperparathyroid
- Presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
- Patients presenting malabsorption syndrome for glucose/galactose
- Person participating in another clinical trial concerning a medicine susceptible to influence bone mass
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00859703
Start Date
November 1 2009
End Date
October 1 2013
Last Update
October 31 2013
Active Locations (1)
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1
Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
Lyon, France, 69437