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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00535860
Eligibility Criteria:
Main Inclusive Criteria:
* Post-menopausal women aged between 55 to 85 years (inclusive)
* Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
* Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.
Main Exclusive Criteria:
* Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
* Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
* Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
* Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT00535860
Study Brief:
Protocol Section:
NCT00535860