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New study aims to predict fracture risk in pregnancy

NCT ID NCT07031557

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tracks bone density and fracture risk in 1,230 pregnant and breastfeeding women using ultrasound scans and diet questionnaires. The goal is to catch early signs of pregnancy-related osteoporosis, a rare condition that can cause painful fractures. No drugs or treatments are being tested—only monitoring tools.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better screening tools to identify pregnant and breastfeeding women at risk of bone fractures.
What could go wrong
This is an observational study, not a treatment trial. It may not directly improve outcomes, and the questionnaires and ultrasound may not accurately predict fracture risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,230 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A cohort of 1230 pregnant women aged 18-45 years and BMI between 18.5 and 34 without secondary osteoporosis and potential pathological conditions that may affect bone health.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signature informed consent * Willingness to participate in the study and ability to complete the study-related questionnaires * Women in the first trimester of pregnancy at the time of inclusion in the study * Age between 18 and 45 years at the time of recruitment in the study * Absence of secondary osteoporosis (induced by diseases or medication use) * Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases) * Women of normal weight or with class I obesity (BMI between 18,5 and 34) Exclusion Criteria: * Absence of informed consent * Low compliance and/or inability to complete the study-related questionnaires * Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities * Age under 18 or over 45 years * BMI less than 18.5 or greater than 34

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Tullio Ghi

    Parma, Italy/Parma, 43126, Italy