ClinicalTrials.gg
CompletedNCT05772364Updated Apr 28, 2026

High- Versus Low-calcium Water for Bone Health

An interventional study of Loading of low-calcium water first, then high-calcium water in Orthopedic Disorder, Calcium Metabolism Disorders and Bone Resorption, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.

Primary conditionBone ResorptionRegistry: Musculoskeletal DiseasesReclassifiedWhy we changed it
Registry
Musculoskeletal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Bone Resorption
Why
  1. The study's listed conditions name Bone Resorption, a narrower term within Musculoskeletal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
25 Years to 55 Years
Sex
All
01

Study summary

The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.

02

Conditions studied

  • Orthopedic Disorder
  • Calcium Metabolism Disorders
  • Bone Resorption
  • Water-Electrolyte Imbalance
  • Eating, Healthy

Browse trials for

03

In context

Bone Resorption Reclassified

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's enrollment of 41 is above the median of 24 across 146 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Compared within Bone Resorption, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Musculoskeletal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 18 and \< 30
  • Maintenance of diet and physical activity lifestyle throughout the duration of the study
  • Acceptance of

Exclusion criteria

Exclusion Criteria:

  • Consumption of water with calcium > 150 mg/L
  • Pregnancy (as established by self-declaration), breastfeeding, menopause
  • Inability to follow the study protocol
  • Cardiac, vascular, renal, and oncological disease
  • Neuropsychiatric disease, developmental disorders
  • Disease or past surgery affecting the gastrointestinal tract
  • Drugs that interfere with bone (e.g. ) or with fluid balance (e.g. diuretics)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Low-calcium water first, then high-calcium water

    Participants drink 1.5 L of the designated water

    Other: Loading of low-calcium water first, then high-calcium water

Interventions

  • OtherLoading of low-calcium water first, then high-calcium water

    All cohort subjects are asked to consume water with less than 5 mg/L of calcium first, then are asked to consume water with at least 400 mg/L of calcium

06

What researchers measure

Primary outcomes

  1. Change of blood calcium levels

    Change of calcium levels (mg/dL) from baseline and after 2.5 hours

    Time frame: Baseline and 2.5 hours

07

Study locations

1 site
  • IRCCS Istituto Ortopedico Galeazzi
    Milan, Milan, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Feb 2026, 35 months.

Of 82 non-industry interventional studies with no phase under Bone Resorption, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 35 months is above that.

Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2023
First posted
Mar 16, 2023
StartActual
Mar 2, 2023
Primary completionActual
Feb 11, 2026
CompletionActual
Apr 23, 2026
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05772364
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Mar 2, 2023
Primary completion
Feb 11, 2026
Completion
Apr 23, 2026
Last update
Apr 28, 2026

Study contacts

Matteo Briguglio
principal investigator · IRCCS Istituto Ortopedico Galeazzi

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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