Actively Recruiting
Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
Led by ANTIMO · Updated on 2025-02-28
100
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
A
ANTIMO
Lead Sponsor
U
University of Campania Luigi Vanvitelli
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study investigates the effects of Fonte Fausta® water on bone and muscle metabolism, as well as quality of life, in patients with osteoporosis or osteopenia, with or without sarcopenia. Conducted as a multicenter, triple-arm trial, it evaluates functional and biochemical markers over 12 months. Patients are randomized into groups receiving either Fonte Fausta® or standard mineral water, with assessments including laboratory tests, bioimpedance analysis, physical and nutritional evaluations, bone density measurements, and quality of life surveys.
CONDITIONS
Official Title
Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary osteopenia or osteoporosis, with or without sarcopenia, based on latest clinical guidelines and EWGSOP2 criteria.
You will not qualify if you...
- Secondary causes of osteoporosis such as prolonged high-dose glucocorticoid use, liver or kidney disease, cancer, neurodegenerative or inflammatory diseases, chronic obstructive pulmonary disease, and endocrine disorders
- Psychiatric disorders that could impair informed consent
- Pregnancy or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vico de Crecchio
Naples, Italy, Italy, 80100
Actively Recruiting
Research Team
A
Antimo Moretti, prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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