Osteoporosis RiskNCT05854342
Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
A study testing bicarbonate-calcium water in people with Osteoporosis Risk, run by University of Salerno at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis Risk
- What is being tested?
- bicarbonate-calcium water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 1 Apr 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Premenopausal women aged ≥40 years
- Menopausal women, period of early menopause 1-10 years
- estrogen-replacement hormone therapy
- osteoporosis therapy
- corticosteroid therapy
- insulin therapy.
Show all 10Show fewer
- calcium supplementation
- kidney diseases of medium-severe level
- liver diseases of medium-severe level
- severe osteoporosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water
- Conditions
- Osteoporosis Risk
- Being tested
- bicarbonate-calcium water
- Keywords
- bicarbonate-calcium water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicarbonate-calcium waterOther
water with high content of bicarbonate and calcium, low sodium
| Study group | Role | What they receive |
|---|---|---|
| bicarbonate-calcium water | Experimental | participants of this group drink bicarbonate-calcium water Receives: Other: bicarbonate-calcium water |
| low mineral water | No intervention | participants of this group drink low mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcium (mg/dL)
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
Measured: 0-3-6 month
25-OH vitamin D (ng/mL)
change of physiological parameter concentration related to calcium metabolism
Measured: 0-3-6 month
osteocalcin (ng/mL)
change of physiological parameter concentration related to calcium metabolism
Measured: 0-3-6 month
Parathyroid hormone (pg/mL)
change of physiological parameter concentration related to calcium metabolism
Measured: 0-3-6 month
Secondary outcomes (1)
NMR metabolomic profile and applications of Metabolomics in calcium metabolism
Metabolomic profile of serum related to calcium metabolism by NMR proton Nuclear Magnetic Resonance spectroscopy (1H-NMR) Metabolomics aims at the quantitative analysis of all metabolites in a biological system, as well as their composition, interactions, and responses to interventions or a specific physiological state. The metabolomics approach correlates broad biochemical changes with health and disease states, and advanced statistical metabolic modeling allows the identification of biomarkers, enabling the quantification of low-molecular-weight metabolites
Measured: 0-3-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Jun 2021
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis RiskStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Collaborators
- San Giuseppe Moscati Hospital
- Responsible party
- Principal investigator, Luca Rastrelli, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854342
- Sponsor's protocol ID
- CECN/1522
- Status last verified
- May 2023
- First submitted
- 14 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3.
PubMed 15744450Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26.
PubMed 18926940
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
- ClinicalTrials.gov ID
- NCT05854342
- Acronym / sponsor ID
- CECN/1522
- Conditions
- Osteoporosis Risk
- Keywords
- bicarbonate-calcium water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Collaborators
- San Giuseppe Moscati Hospital
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 May 2023 (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.
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bicarbonate-calcium water | Experimental | Other: bicarbonate-calcium waterparticipants of this group drink bicarbonate-calcium water |
| low mineral water | No intervention | –participants of this group drink low mineral water |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Premenopausal women aged ≥40 years
- Menopausal women, period of early menopause 1-10 years
- estrogen-replacement hormone therapy
- osteoporosis therapy
- corticosteroid therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| bicarbonate-calcium waterwater with high content of bicarbonate and calcium, low sodium | Other | bicarbonate-calcium water |
Primary outcome
calcium (mg/dL)
Time frame: 0-3-6 month
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
25-OH vitamin D (ng/mL)
Time frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
osteocalcin (ng/mL)
Time frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
Parathyroid hormone (pg/mL)
Time frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
1 secondary outcome
NMR metabolomic profile and applications of Metabolomics in calcium metabolism
Time frame: 0-3-6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 15744450Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3.
- Background: PubMed 18926940Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bicarbonate-calcium water in people with Osteoporosis Risk, run by University of Salerno 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 11 May 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calcium (mg/dL) (time frame: 0-3-6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854342, which also lists 2 linked publications.
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 11 May 2023.