Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.
Inclusion Criteria:
- 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
- With written informed consent signed
- With social security
Exclusion Criteria:
- 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