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

February 24, 2025 updated by: ANTIMO

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: 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.
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.
Other: Water (Placebo)
a natural mineral commercially available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance Analysis (BIA)
Time Frame: 0 (T0), 180 (T1), and 365 days (T2)
Bioimpedance Analysis (BIA) is a non-invasive method used to assess body composition, including fat mass, muscle mass, and total body water. It works by measuring the resistance of electrical currents as they pass through the body's tissues, with lean tissues (muscle and water) conducting electricity better than fat tissues.
0 (T0), 180 (T1), and 365 days (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory Tests
Time Frame: 0 (T0), 180 (T1), and 365 days (T2)
Blood samples (20 ml), a 24-hour urine collection, and early morning urine analyses will be conducted to evaluate key biochemical markers, including ALP, bone-specific ALP, PTH, 25(OH)D3, CTX, among others.
0 (T0), 180 (T1), and 365 days (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANTIMO

Collaborators

University of Campania Luigi Vanvitelli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOCUS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be shared upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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