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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00369850
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Resected disease
* Enrolled on protocol IBCSG-1-98
* Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
* Letrozole
* Tamoxifen
* Letrozole after 2 years of tamoxifen
* Tamoxifen after 2 years of letrozole
* Not yet completed 5 years of treatment
* No breast cancer recurrence or second primary cancer
* No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
* No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
* Hormone receptor status:
* Estrogen receptor-positive and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
* No malabsorption syndrome or clinically relevant vitamin D deficiency
* No patients for whom the bone density determination is impossible
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 1 year since prior and no concurrent anticonvulsants
* More than 6 weeks since prior and no concurrent corticosteroids (at doses \> the equivalent of 5 mg/day prednisone) for \> 2 weeks total
* No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for \> 1 month
* More than 12 months since prior and no concurrent anabolic steroids
* More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\])
* No concurrent raloxifene
* Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
* Concurrent warfarin allowed provided it is given for ≤ 4 weeks
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT00369850
Study Brief:
Protocol Section:
NCT00369850