Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients

NCT ID: NCT06851676

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-09-10

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.

Detailed Description

This study aims to determine the impact of Fonte Fausta® water on bone and muscle metabolism in patients with osteoporosis or osteopenia, with or without sarcopenia, over a 12-month period. The research follows ethical guidelines (Helsinki Declaration) and has been approved by the Ethics Committee of the University of Campania "Luigi Vanvitelli." All participants provided informed consent.

Study Design and Participants The study is a multicenter, triple-arm interventional clinical trial conducted at the University of Campania "Luigi Vanvitelli." Participants include individuals diagnosed with primary osteoporosis or osteopenia, with or without sarcopenia, based on clinical guidelines and the EWGSOP2 criteria. Osteoporosis is diagnosed by a BMD T-score ≤ -2.5 SD or the presence of a fragility fracture, while osteopenia is defined as a BMD T-score between -1 and -2.5 SD. Sarcopenia diagnosis is based on low muscle strength and low muscle mass.

Exclusion criteria include secondary osteoporosis causes (e.g., chronic diseases, endocrine disorders, long-term corticosteroid use), psychiatric conditions affecting consent, and pregnancy or breastfeeding.

Study Groups and Randomization

Participants are divided into three primary groups:

Patients with osteoporosis/osteopenia and sarcopenia Patients with osteoporosis/osteopenia without sarcopenia A control group with non-osteometabolic conditions

Each group is further randomized into two subgroups:

One receiving Fonte Fausta® water One receiving natural mineral water Assessments and Evaluations

Participants undergo evaluations at three time points:

Baseline (T0) Six months (T6) Twelve months (T12)

Key assessments include:

Laboratory Tests: Blood and urine analyses to assess biochemical markers such as ALP, bone-specific ALP, PTH, 25(OH)D3, and CTX.

Bioimpedance Analysis (BIA): Measures body composition, including fat and muscle mass.

Physical and Nutritional Assessments: Includes questionnaires like the International Physical Activity Questionnaire, handgrip strength measurements, and the Mini Nutritional Assessment.

Bone Health and Fall Risk: DXA scans measure BMD, and the FRAX® algorithm estimates fracture risk.

Pain, Performance, and Quality of Life: Evaluations include the Short Physical Performance Battery (SPPB), Brief Pain Inventory (BPI), and quality of life questionnaires (EQ-5D-3L and EQ-VAS).

This study aims to determine whether Fonte Fausta® water offers functional and metabolic benefits for bone and muscle health, potentially improving quality of life and reducing fracture risk in osteoporotic and osteopenic patients.

Conditions

Osteopenia, Osteoporosis; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

water supplemented by calcium

Intervention Type: DIETARY_SUPPLEMENT

Fonte Fausta® water is a natural mineral water, rich in essential minerals, such as calcium, magnesium, and bicarbonate, which are important for maintaining bone density, muscle function, and overall metabolic health.

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.

Group Type: PLACEBO_COMPARATOR

Water (Placebo)

Intervention Type: OTHER

a natural mineral commercially available

Interventions

water supplemented by calcium

Fonte Fausta® water is a natural mineral water, rich in essential minerals, such as calcium, magnesium, and bicarbonate, which are important for maintaining bone density, muscle function, and overall metabolic health.

Intervention Type: DIETARY_SUPPLEMENT

Water (Placebo)

a natural mineral commercially available

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

ANTIMO

OTHER

Sponsor Role: lead

Responsible Party

ANTIMO

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vico de Crecchio

Naples, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antimo Moretti, prof

Role: CONTACT

antimo.moretti@unicampania.it

+390815665526

Facility Contacts

antimo moretti

Role: primary

antimo.moretti@unicampania.it

+390815665537

Other Identifiers

FOCUS01

Identifier Type: -

Identifier Source: org_study_id