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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT00577395
Eligibility Criteria:
Inclusion Criteria:
* Female: 40 and 57 years of age inclusive
* cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
* have osteopenia defines as having the following: have osteopenia defined as having the following:
* Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
* Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
* have a body mass index (BMI) between 18 and 30 kg/m2.
Exclusion Criteria:
* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
57 Years
Study:
NCT00577395
Study Brief:
Protocol Section:
NCT00577395