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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT03623633
Eligibility Criteria:
Inclusion Criteria:
* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines
Exclusion Criteria:
* no significant previous use of bone health modifying treatments
* hip fracture within one year of enrollment
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
* known contraindications to denosumab, alendronate, or raloxifene
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT03623633
Study Brief:
Protocol Section:
NCT03623633