Osteopenia, OsteoporosisFOCUSNCT06851676
Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
A study testing water supplemented by calcium in people with Osteopenia, Osteoporosis and Sarcopenia, run by ANTIMO at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteopenia, Osteoporosis, Sarcopenia
- What is being tested?
- water supplemented by calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2024to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- -a diagnosis of primary osteopenia or osteoporosis , with or without sarcopenia, based on the latest clinical practice guidelines and EWGSOP2 criteria .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vico de Crecchio
Naples, Italy, 80100
antimo moretti, +390815665537, antimo.moretti@unicampania.it
About this study
Official title: 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.
Read the 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
- Being tested
- water supplemented by calcium, Water (Placebo)
- Keywords
- osteoporosis, sarcopenia, functioning, calcium, water
- Medical subject headings
- Bone Diseases, Metabolic, Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water supplemented by calciumDietary 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.
Water (Placebo)Other
a natural mineral commercially available
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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. Receives: Dietary Supplement: water supplemented by calcium |
| control | Placebo comparator | 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. Receives: Other: Water (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance Analysis (BIA)
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.
Measured: 0 (T0), 180 (T1), and 365 days (T2)
Secondary outcomes (1)
Laboratory Tests
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.
Measured: 0 (T0), 180 (T1), and 365 days (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Jul 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia, OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANTIMO
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor-investigator, ANTIMO, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851676
- Sponsor's protocol ID
- FOCUS01
- Acronym
- FOCUS
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Metabolic Effects of Fonte Fausta® Water on the Musculoskeletal System in Patients with Osteoporosis/Osteopenia with or Without Sarcopenia
- ClinicalTrials.gov ID
- NCT06851676
- Acronym / sponsor ID
- FOCUS / FOCUS01
- Conditions
- Osteopenia, Osteoporosis, Sarcopenia
- Keywords
- osteoporosis, sarcopenia, functioning, calcium, water
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ANTIMOUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: water supplemented by calciumEnrolled 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. |
| control | Placebo comparator | Other: Water (Placebo)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -a diagnosis of primary osteopenia or osteoporosis , with or without sarcopenia, based on the latest clinical practice guidelines and EWGSOP2 criteria .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water supplemented by calciumFonte 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. | Dietary supplement | intervention |
| Water (Placebo)a natural mineral commercially available | Other | control |
Primary outcome
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.
1 secondary outcome
Laboratory Tests
Time frame: 0 (T0), 180 (T1), and 365 days (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes. data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water supplemented by calcium in people with Osteopenia, Osteoporosis and Sarcopenia, run by ANTIMO at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antimo Moretti, prof (+390815665526, antimo.moretti@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance Analysis (BIA) (time frame: 0 (T0), 180 (T1), and 365 days (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.