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

NCT06847087 | Recruiting

• 2 other identifiers: HCC-008ID-RCB 2024-A02648-39
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis, Post-Traumatic; Calcium Supplementation; Osteoporosis, Management Care, Fracture

Outcome Measures

Primary Outcomes (1)

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

  percentage of patients

  Day 1

Secondary Outcomes (5)

• Previously performed bone densitometry

  Day 1

• Prevalence of a history of fracture

  Day 1

• First indication for the initiation of anti-osteoporotic treatment.

  Day 1

• Duration without treatment before a fracture occurs

  Day 1

• Number of participants who need for readjustment by the rheumatologist after inclusion

  Day 1

Interventions

Self-questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in a rheumatology department for a hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Colmar: lead

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, 68024, France

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Central Study Contacts

Lionel SPIELMANN, MD

CONTACT

03.89.12.41.34; lionel.spielmann@ch-colmar.fr

Elina HAERREL

CONTACT

03 89 12 45 57; elina.haerrel@ch-colmar.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: April 3, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

FR (1)