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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT01144468
Eligibility Criteria:
Inclusion Criteria:
Women participating in the MAP.3 clinical trial at centres with access to HR-pQCT
Exclusion Criteria:
1. Women with osteoporosis;
2. Women with T-score of -2.0 or below at the lumbar spine (L1-L4), total hip or femoral neck;
3. Women with a fragility fracture after age 40;
4. Women who have been on any bone drug, such as hormone replacement therapy, selective estrogen receptor modulators, bisphosphonates, teriparatide, parathyroid hormone, sodium fluoride, strontium, calcitonin and high dose vitamin D (more than 2000iu of vitamin D3 daily),in the past 3 months;
5. Women who have ever been on a bisphosphonate for more than 6 months;
6. Women who have ever been on strontium for more than 1 month;
7. Women who are on chronic oral steroids (the equivalent of 5mg of prednisone a day or higher for more than 2 weeks within the past 6 months and will likely require ongoing therapy);
8. Women with Paget's disease, Cushing's disease, hyperparathyroidism, uncontrolled hyperthyroidism or other metabolic bone diseases;
9. Women with decompensated diseases of the liver, bowel, kidney, pancreas, lung, or heart.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01144468
Study Brief:
Protocol Section:
NCT01144468