Osteoporosis, Post-TraumaticMONTE-CRIST'OSNCT06847087
Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After a Fracture
An observational study of Osteoporosis, Post-Traumatic and Calcium Supplementation, run by Centre Hospitalier de Colmar at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Post-Traumatic, Calcium Supplementation, Osteoporosis, Management Care, Fracture
- What is being tested?
- Self-questionnaire
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2025to 29 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting in a rheumatology department for a hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
- Being tested
- Self-questionnaire
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaireOther
Assessment of the inadequacy between dietary and medicinal calcium intake by the Fardellone self-questionnaire and the patient's clinical record
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients deficient, within the norm and above the norm with or without supplementation
percentage of patients
Measured: Day 1
Secondary outcomes (5)
Previously performed bone densitometry
Results of densitormetry by a T score
Measured: Day 1
Prevalence of a history of fracture
Number of bone fractures the patient has already had before inclusion
Measured: Day 1
First indication for the initiation of anti-osteoporotic treatment.
Date of the first indication for the initiation of an anti-osteoporotic treatment.
This date is appearing in the medical record
Measured: Day 1
Duration without treatment before a fracture occurs
Duration without treatment before a fracture occurs and type of the treatment
Measured: Day 1
Number of participants who need for readjustment by the rheumatologist after inclusion
Implementation of educational measures by the rheumatologist in the event of inadequacy and optimization of anti-osteoporotic treatments
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start3 Apr 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Colmar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847087
- Sponsor's protocol ID
- HCC-008
- Other IDs
- ID-RCB 2024-A02648-39
- Acronym
- MONTE-CRIST'OS
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06847087
- Acronym / sponsor ID
- MONTE-CRIST'OS / HCC-008
- Conditions
- Osteoporosis, Post-Traumatic, Calcium Supplementation, Osteoporosis, Management Care, Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier de ColmarUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in a rheumatology department for a hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaireAssessment of the inadequacy between dietary and medicinal calcium intake by the Fardellone self-questionnaire and the patient's clinical record | Other | – |
Primary outcome
Number of patients deficient, within the norm and above the norm with or without supplementation
Time frame: Day 1
percentage of patients
5 secondary outcomes
Previously performed bone densitometry
Time frame: Day 1
Prevalence of a history of fracture
Time frame: Day 1
First indication for the initiation of anti-osteoporotic treatment.
Time frame: Day 1
Duration without treatment before a fracture occurs
Time frame: Day 1
Number of participants who need for readjustment by the rheumatologist after inclusion
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Post-Traumatic and Calcium Supplementation, run by Centre Hospitalier de Colmar at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients deficient, within the norm and above the norm with or without supplementation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.