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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00354302
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27
* Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27
* Hormone receptor status:
* Estrogen receptor- and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* No malabsorption syndrome
* No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease
* No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease
* No other bone disease (including osteomalacia or osteogenesis imperfecta)
PRIOR CONCURRENT THERAPY:
* More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)
* More than 12 months since prior and no concurrent anticonvulsants
* More than 6 months since prior and no concurrent corticosteroids at doses \> 5 mg/day of prednisone (or equivalent) for \> 2 weeks
* More than 12 months since prior and no concurrent anabolic steroids
* No prior bisphosphonates (stratum II)
* No concurrent sodium fluoride at daily doses ≥ 5 mg/day
* No long-term (i.e., \> 6 months) use of coumarins
* No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis \[stratum I\])
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
120 Years
Study:
NCT00354302
Study Brief:
Protocol Section:
NCT00354302