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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01935804
Eligibility Criteria:
Inclusion Criteria:
* BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;
* No prior antidiabetic therapy;
* Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);
* Body-mass index of 40 Kg/m2 and less;
* Stable body weight for at least 4 months.
Exclusion Criteria:
* Type 1 diabetes mellitus (presence of GAD auto antibodies);
* History of diabetes or uncontrolled hypertension;
* Treatment with antidiabetic agents including TZDs;
* Chronic diseases known to affect bone;
* Previous treatment with estrogens and other medications known to affect bone ;
* Creatinine clearance less than 60 ml/min
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT01935804
Study Brief:
Protocol Section:
NCT01935804