ClinicalTrials.gov record NCT07169669

Multicentre Longitudinal Study of Bone Mineralisation Characteristics in Marfan Syndrome and Ehlers-Danlos Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

Multicentre Longitudinal Study of Bone Mineralisation Characteristics in Marfan Syndrome and Ehlers-Danlos Syndrome

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study uses existing clinical records and bone density scans to describe bone mineralisation in people with Marfan syndrome or Ehlers-Danlos syndrome. It will analyse past bone mineral densitometry exams and related medical-history data for adult and pediatric patients. The study aims to characterise bone features, their change over time, and how they relate to other clinical findings.

What it is studying. The study is testing how bone mineralisation appears in people with Marfan syndrome and Ehlers-Danlos syndrome, whether those bone measures change over time, and how they relate to other clinical and medical-history features by analysing existing bone density records.

What the researchers hope to learn. To measure the percentage of people with fractures in the analysed records; to identify patients meeting osteoporosis or osteopenia thresholds (T-score and pediatric z-score criteria); and to describe trabecular bone score (TBS) categories and other bone-mineralisation characteristics.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The general objective of this research is to evaluate the characteristics of bone mineralisation in patients with Marfan syndrome or Ehlers-Danlos syndrome on a large case series. In particular we intend to obtain data regarding the characteristics of bone mineralisation, as well as their variation over time and the relationships existing with other clinical-anamnestic parameters, in patients with Marfan syndrome or Ehlers-Danlos syndrome by retrospectively analysing (data already collected for normal clinical practice and already available at the hospital) the case history of the Cardiovascular genetic center at IRCCS Policlinico San Donato and the related Computerized Bone Mineralometry (MOC) examinations performed at the Radiology Service of the same hospital between 1 September 2019 and 31 December 2022.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Subjects with Marfan syndrome and Ehlers-Danlos syndrome according to the revised reference criteria belonging to the Cardiovascular genetic center at IRCCS Policlinico San Donato and the Reference Centre for Ehlers-Danlos Syndromes Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico;
  • Adult and paediatric subjects who have performed at least one Bone Mineral Densitometry within the observation period of the study.

Exclusion criteria

  • Presence of prostheses in the spinal column;
  • Presence of prostheses in the coxofemoral joint;
  • Oncological bone diseases reported in history.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

The study is retrospective: researchers will review and analyse existing medical records and computerized bone mineralometry (MOC) exams already performed during the observation period (1 Sep 2019–31 Dec 2022). No new tests, treatments, or procedures are listed in the registry. The team will extract information such as fracture history, T-scores/Z-scores and trabecular bone score (TBS) from those records for analysis.

How the study is structured. A retrospective observational cohort: researchers will review and analyse existing clinical records and bone mineral density (densitometry) exams collected during routine care (records dated from 1 September 2019 as listed in the registry).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Marfan syndrome

Clinical trials20 trials listed for Marfan syndromeEvery trial the registry lists for Marfan syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Marfan syndrome researchLatest monthly update: September 2026. Includes: After open aortic repair. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 31, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Study completion
May 31, 2026 (estimated)
Target enrollment
150 participants (estimated)
Last updated on registry
Sep 12, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
IRCCS Policlinico S. Donato
Collaborators
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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