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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT06375668
Eligibility Criteria:
Inclusion Criteria:
1. Postmenopausal women (between 2 and 5 years after their last menstrual period)
2. A dual-energy X-ray absorptiometry (DEXA) scan-based T-score of the lumbar spine (L1-L4) of less than -1.49 (i.e. a normal value according to the World Health Organization)
3. Body mass index (BMI) between 18 and 30
4. Vitamin 25 (OH)D levels between 31-50 ng/mL
Exclusion Criteria:
1. The last menstrual period less than 2 or more than 5 years before study recruitment
2. BMI under 18 or above 30
3. Oral or transdermal hormone therapy with estrogens and/or progestogens within the last 6 months
4. Corticosteroid or thyroid hormone therapy within the last 6 months
5. History of osteopenia or osteoporosis
6. Neoplastic disease treated with cytostatic agents within the last 12 months
7. Autoimmune disorders, including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis; malabsorption syndromes, including celiac disease; chronic kidney disease; chronic liver failure; endocrine disorders, including Hashimoto thyroiditis, Graves' disease, Cushing disease or syndrome, hyperparathyroidism, hypogonadism, hyperprolactinemia, acromegaly, diabetes mellitus; and other chronic conditions affecting bone metabolism
8. Antibiotic therapy within the last 2 months prior to study recruitment
9. Probiotic use within the last 2 months prior to study recruitment
10. Calcium and vitamin D supplementation within the 2 months prior to study recruitment
11. Treatment with antidepressant or antipsychotic agents involving a change of the agents or dosage within the last 3 months
12. Substance use disorder (alcohol, drugs, nicotine)
13. History of organ transplantation
14. Exposure to the SARS-Cov-2 virus within 14 days prior to study recruitment (based on patient declaration)
15. An acute COVID-19 infection within 14 days prior to study recruitment (based on patient declaration)
16. A surgical procedure scheduled to take place during this study
17. Participation in another study within the last 6 months
18. Inability to give an informed consent in writing
19. Any disease or circumstances that, according to the Investigator or Sponsor, might prevent the subject from completing the study or following study procedures and requirements
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT06375668
Study Brief:
Protocol Section:
NCT06375668