NCT06851676 Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
| NCT ID | NCT06851676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ANTIMO |
| Condition | Osteopenia, Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-07-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: -a diagnosis of primary osteopenia or osteoporosis , with or without sarcopenia, based on the latest clinical practice guidelines and EWGSOP2 criteria . Exclusion Criteria: * 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.