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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT00577850
Eligibility Criteria:
Inclusion Criteria:
* have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol \< 20 pg/mL and follicle stimulating hormone (FSH) \> 40 IU/mL;
* have osteopenia or osteoporosis (\< 1.002 g/cm2 Lunar or \< 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately \< -1.5.
Exclusion Criteria:
* any clinically significant out-of-range laboratory values and vital signs,
* a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator
* a known hypersensitivity to bisphosphonates
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00577850
Study Brief:
Protocol Section:
NCT00577850