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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT00567606
Eligibility Criteria:
Inclusion Criteria:
* read, speak and understand English;
* be female;
* be between the ages of 35 and 75;
* have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study;
* be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH \>40 IU/ml);
* have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and
* have agreement of their primary care provider for participation in the study.
Exclusion Criteria:
* have a recurrence of their breast cancer;
* currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.;
* currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly;
* have a body mass index (BMI) equal to or greater than 35;
* have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits;
* have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers;
* have Paget=s disease;
* have renal disease (renal stones or serum creatinine levels greater than the upper normal limits);
* have a recent history of a spinal fracture (within the past 6 months);
* have features of an acute fracture on baseline spinal x-rays;
* have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00567606
Study Brief:
Protocol Section:
NCT00567606