Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT00859703
Eligibility Criteria:
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\<T score\<-1) without osteoporotic fracture
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00859703
Study Brief:
Protocol Section:
NCT00859703