Functional and Metabolic Effects of Fonte Fausta® Water on the Musculoskeletal System in Patients with Osteoporosis/Osteopenia with or Without Sarcopenia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• a diagnosis of primary osteopenia or osteoporosis , with or without sarcopenia, based on the latest clinical practice guidelines and EWGSOP2 criteria .

Locations
Other Locations
Italy
Vico de Crecchio
RECRUITING
Naples
Contact Information
Primary
Antimo Moretti, prof
antimo.moretti@unicampania.it
+390815665526
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2025-09-10
Participants
Target number of participants: 100
Treatments
Experimental: intervention
Enrolled patients will be divided into three groups: patients with osteoporosis/osteopenia accompanied by sarcopenia, patients with osteoporosis/osteopenia without sarcopenia, and a control group with non-osteometabolic conditions. Each group has been randomized into two subgroups: one receiving Fonte Fausta® and the other receiving natural mineral water.
Placebo_comparator: control
Enrolled patients will be divided into three groups: patients with osteoporosis/osteopenia accompanied by sarcopenia, patients with osteoporosis/osteopenia without sarcopenia, and a control group with non-osteometabolic conditions. Each group has been randomized into two subgroups: one receiving Fonte Fausta® and the other receiving natural mineral water.
Related Therapeutic Areas
Sponsors
Leads: ANTIMO
Collaborators: University of Campania Luigi Vanvitelli

This content was sourced from clinicaltrials.gov