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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-07-10 with a primary completion date of 2025-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06851676 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Osteopenia, Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06851676 currently recruiting?
Yes, NCT06851676 is actively recruiting participants. Contact the research team at antimo.moretti@unicampania.it for enrollment information.
Where is the NCT06851676 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT06851676 clinical trial?
NCT06851676 is sponsored by ANTIMO. The trial plans to enroll 100 participants.