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Completed

NCT Number: NCT06847087

Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After a Fracture

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.

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Key information

Conditions

Osteoporosis, Post-Traumatic Bone Diseases Bone Diseases, Metabolic Calcium Supplementation Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Management Care, Fracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-questionnaire

Other

Assessment of the inadequacy between dietary and medicinal calcium intake by the Fardellone self-questionnaire and the patient's clinical record

Primary outcomes

  1. Number of patients deficient, within the norm and above the norm with or without supplementation

    Time frame: Day 1

    percentage of patients

Secondary outcomes

  1. Previously performed bone densitometry

    Time frame: Day 1

    Results of densitormetry by a T score

  2. Prevalence of a history of fracture

    Time frame: Day 1

    Number of bone fractures the patient has already had before inclusion

  3. 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

  4. Duration without treatment before a fracture occurs

    Time frame: Day 1

    Duration without treatment before a fracture occurs and type of the treatment

  5. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Colmar

Other

Registry information

Official study title

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.

Acronym: MONTE-CRIST'OS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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