Status:
COMPLETED
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
National Hellenic Research Foundation
Conditions:
Osteopenia
Postmenopausal Osteopenia
Eligibility:
FEMALE
50-70 years
Phase:
NA
Brief Summary
It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its micro...
Eligibility Criteria
Inclusion
- Postmenopausal women
- T-score in the osteopenic range (-1.0 \> T-score \> -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)
Exclusion
- T-score in the osteoporotic range (T-score \< -2.5) at any site
- Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
- Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
- Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
- Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2024
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT05421819
Start Date
June 15 2022
End Date
January 24 2024
Last Update
March 7 2024
Active Locations (1)
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1
Laboratory for Research of the Musculoskeletal System
Kifissia, Athens, Greece, 14561