Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After a Fracture (MONTE-CRIST'OS)

April 2, 2026 updated by: Centre Hospitalier de Colmar

Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After Fracture With a Fracture Suspected of Being Due to Bone Insufficiency, Consulting a Rheumatologist for the First Time in at Least 5 Years.

Osteoporosis is a disease that causes many fractures. However, treatments exist such as anti-osteoporotic treatments, vitamin D supplementation and an adaptation of calcium intake. 80% of patients with an indication for anti-osteoporotic treatment are never treated with these anti-osteoporotic treatments after a first fracture. On the other hand, more than 84% of them are supplemented with calcium and vitamin D. It often appears in the practice of rheumatologists that some patients are supplemented while their dietary intake is sufficient, and vice versa. The objective of the study is therefore to take stock of the (in)adequacy between the dietary intake of patients and the supplementation prescribed to them following an osteoporotic-like fracture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colmar, France, 68024
        • Hôpitaux Civils de Colmar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients consulting in a rheumatology department for a hospital

Description

Inclusion Criteria:

  • Patient meeting a first rheumatologist after a fracture suspected of being due to bone insufficiency, whether or not he is already treated for osteoporosis
  • Age ≥ 18 years
  • Patient followed in one of the three investigation centers within the framework of the bone sector.
  • Patient affiliated to a social security system

Exclusion Criteria:

  • Patient refusing to participate in the study
  • Patient already followed by a rheumatologist
  • Legal incapacity or any physical, psychological, social or geographical condition likely to hinder the patient's ability to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients deficient, within the norm and above the norm with or without supplementation
Time Frame: Day 1
percentage of patients
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Previously performed bone densitometry
Time Frame: Day 1
Results of densitormetry by a T score
Day 1
Prevalence of a history of fracture
Time Frame: Day 1
Number of bone fractures the patient has already had before inclusion
Day 1
First indication for the initiation of anti-osteoporotic treatment.
Time Frame: Day 1

Date of the first indication for the initiation of an anti-osteoporotic treatment.

This date is appearing in the medical record
Day 1
Duration without treatment before a fracture occurs
Time Frame: Day 1
Duration without treatment before a fracture occurs and type of the treatment
Day 1
Number of participants who need for readjustment by the rheumatologist after inclusion
Time Frame: Day 1
Implementation of educational measures by the rheumatologist in the event of inadequacy and optimization of anti-osteoporotic treatments
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Colmar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Actual)

January 29, 2026

Study Completion (Actual)

January 29, 2026

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-008
  • ID-RCB 2024-A02648-39 (Other Identifier: Hôpitaux Civils de Colmar)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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