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 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT01575834
Eligibility Criteria:
Inclusion Criteria:
\- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)
Exclusion Criteria:
* BMD T-score of ≤ -3.50 at the total hip or femoral neck
* History of hip fracture
* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT01575834
Study Brief:
Protocol Section:
NCT01575834