Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
Functional and Metabolic Effects of Fonte Fausta® Water on the Musculoskeletal System in Patients with Osteoporosis/Osteopenia with or Without Sarcopenia
This study is testing if drinking Fonte Fausta® water can improve bone and muscle health, as well as overall quality of life, for people with osteoporosis or osteopenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples, Italy) |
| Trial ID | NCT06851676 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates how Fonte Fausta® water affects 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, participants are randomized into groups receiving either Fonte Fausta® or standard mineral water over a 12-month period. The study evaluates various functional and biochemical markers through laboratory tests, bioimpedance analysis, physical and nutritional assessments, bone density measurements, and quality of life surveys. Ethical guidelines are followed, and informed consent is obtained from all participants.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary osteoporosis or osteopenia, with or without sarcopenia.
Not a fit: Patients with secondary causes of osteoporosis or those with psychiatric conditions affecting consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone and muscle health in patients with osteoporosis and enhance their quality of life.
How similar studies have performed: While the specific use of Fonte Fausta® water is novel, similar studies exploring the effects of mineral water on bone health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Naples, Italy
- Vico de Crecchio — Naples, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Antimo Moretti, prof
- Email: antimo.moretti@unicampania.it
- Phone: +390815665526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.