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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT07010432
Eligibility Criteria:
Inclusion criteria
* Female.
* Post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (FSH) 16 - 130 international units per liter (IU/L), and low levels of anti-müllerian hormone (AMH) and inhibin B).
* Age 50-70 years (both inclusive) at the time of signing the informed consent.
* Body Mass Index (BMI) greater than or equal to \>= 30.0 kilograms per square meter (kg/m\^2).
Exclusion criteria
* Previous or current bone disease (e.g., osteoporosis, Paget's disease of bone, or bone cancer).
* Presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)).
* Treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (HRT), or systemic corticosteroids).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT07010432
Study Brief:
Protocol Section:
NCT07010432