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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT03812367
Eligibility Criteria:
Inclusion Criteria:
1. Women at least 50 years of age who are postmenopausal. Postmenopausal is defined as being amenorrheic for at a period of at least 12 months.
2. Diagnosis of osteoporosis by T score of \< -2.5 at either lumbar spine or the hip/femoral neck, or osteopenia that qualifies for treatment by FRAX calculation (10-year risk of hip fracture \> 3% and/or major osteoporotic fracture of \> 20%).
3a. Subjects who have had chronic treatment of denosumab (as defined as \> 1 year \[at least 3 6-monthly injections\]) or zoledronic acid (defined as ≥ 2 years \[at least 2 annual injections\]) . Note: At the time of treatment initiation, subjects must have met criteria for on-label use (e.g. criterion 2 above).
OR 3b. Subjects who are naïve to treatment with denosumab and/or zoledronic acid.
Exclusion Criteria:
1. Renal insufficiency, with glomerular filtration rate (GFR) \< 35 ml/min.
2. Hypocalcemia within 6 months of study initiation.
3. Known hypersensitivity to denosumab or zoledronic acid.
4. Medications that could alter bone turnover including prednisone, anti-rheumatic medications, anti-metabolites (Cytoxan). Subjects who have been on stable doses of thyroid replacement or diabetes medications for more than 3 months are eligible.
5. Evidence of untreated oral cavities or oral infections. Preventative dental exams should be performed before starting denosumab or zoledronic acid. Subjects must avoid invasive dental procedures during treatment with denosumab or zoledronic acid.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT03812367
Study Brief:
Protocol Section:
NCT03812367