Clinical trial NCT06851676: Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
Official title: Functional and Metabolic Effects of Fonte Fausta® Water on the Musculoskeletal System in Patients with Osteoporosis/Osteopenia with or Without Sarcopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteopenia, Osteoporosis
Sarcopenia
Keywords: osteoporosis
sarcopenia
functioning
calcium
water
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: University of Campania Luigi Vanvitelli
First posted: 2025-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bioimpedance Analysis (BIA)
timeFrame: 0 (T0), 180 (T1), and 365 days (T2)
Secondary outcomes:
measure: Laboratory Tests
timeFrame: 0 (T0), 180 (T1), and 365 days (T2)
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Vico de Crecchio
Study officials:
References: