OsteoporosisASCONCT07660484
Link Between ASCorbemia Level and Osteoporosis
A study testing Plasma vitamin C assessment in people with Osteoporosis and Vitamin C Deficiency, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This monocentric observational study aims to evaluate the association between plasma vitamin C levels (ascorbemia) and the presence of osteoporotic vertebral fractures in patients with osteoporosis. Forty participants will be enrolled at the Rheumatology Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Vitamin C Deficiency, Vertebral Fractures
- What is being tested?
- Plasma vitamin C assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 50 yars or older ;
- Postmenopausal women ;
- Afilliated with a health insurance and system ;
- Written informed consent obtained.
- Group 1 : Clincal osteoporotic vertebral fracture confirmed by imaging within the previous month ; Followed in the Rheumatology department for management of vertebral fracture.
- Group 2 : Densitometric osteoporosis (T-score ≤ -2.5) ; No history of severe osteoporotic fracture ; No history of clinical or morphometric vertebral fracture.
Who cannot join
- Legal protection measure (guardianship, curatorship);
- inability to provide informed consent ;
- refusal to participate ;
- Vertebral fracture related to tumor,
- infection, trauma or non osteoporotic causes ;
- asymptomatic vertebral fracture discovered incidentally ;
- Severe densitometric osteoporosis for group 2 ;
- Previous severe osteoporotic fracture for group B.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nice
Nice, France, 06000
Marie-charlotte Trojani, Doctor, 0492034702, trojani.mc@chu-nice.fr
About this study
Official title: ASCO Study: Link Between ASCorbemia Level and Osteoporosis
This monocentric observational study aims to evaluate the association between plasma vitamin C levels (ascorbemia) and the presence of osteoporotic vertebral fractures in patients with osteoporosis. Forty participants will be enrolled at the Rheumatology
Read the detailed description
- . Patients in group A or B will be seen in consultation or admitted by one of the medical team members among the investigators.
- . After signing the informed consent and checking the inclusion criteria, the blood sample will be taken by a member of the nursing team of the department.
- . The collection tube will then be placed in an opaque cooler, refrigerated with ice, and transported to the university hospital's biochemistry lab (routine assay).
- . Next, the collection of planned clinical and paraclinical data:
- Diet and risk factors for vitamin C deficiency:
- Demographic data - osteoporosis risk factors
- Bone status
- . Once all the data is collected, we will carry out the statistical analyses, then draft the article, and finally publish it.
- Conditions
- Osteoporosis, Vitamin C Deficiency, Vertebral Fractures
- Being tested
- Plasma vitamin C assessment
- Medical subject headings
- Osteoporosis, Ascorbic Acid Deficiency, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma vitamin C assessmentDiagnostic test
Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient of the study
| Study group | Role | What they receive |
|---|---|---|
| Osteoporosis with vertebral fracture | Experimental | Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis and recent clincal vertebral fracture. Receives: Diagnostic Test: Plasma vitamin C assessment |
| Non-severe osteoporosis | Experimental | Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis without vertebral fracture. Receives: Diagnostic Test: Plasma vitamin C assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma vitamin C concentration
Comparison of plasma vitamin C concentration (ascorbemia, µmol/L) between patients with osteoporotic vertebral fractures and patients with osteoporosis without vertebral fracture.
Measured: day 1
Secondary outcomes (2)
Association between plasma vitamin C level and number of vertebral fractures
Assessment of the relationship between plasma vitamin C concentration and the number of osteoporotic vertebral fractures
Measured: day 1
Association between plasma vitamin C level and lumbar bone mineral density
Assessment of the relationship between plasma vitamin C concentration and lumbar spine bone mineral density measured by DXA.
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 posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660484
- Sponsor's protocol ID
- 25-AOI-08
- Other IDs
- IDRCB
- Acronym
- ASCO
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASCO Study: Link Between ASCorbemia Level and Osteoporosis
- ClinicalTrials.gov ID
- NCT07660484
- Acronym / sponsor ID
- ASCO / 25-AOI-08
- Conditions
- Osteoporosis, Vitamin C Deficiency, Vertebral Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Jun 2026 (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.
This monocentric observational study aims to evaluate the association between plasma vitamin C levels (ascorbemia) and the presence of osteoporotic vertebral fractures in patients with osteoporosis. Forty participants will be enrolled at the Rheumatology
Detailed description
- . Patients in group A or B will be seen in consultation or admitted by one of the medical team members among the investigators.
- . After signing the informed consent and checking the inclusion criteria, the blood sample will be taken by a member of the nursing team of the department.
- . The collection tube will then be placed in an opaque cooler, refrigerated with ice, and transported to the university hospital's biochemistry lab (routine assay).
- . Next, the collection of planned clinical and paraclinical data:
- Diet and risk factors for vitamin C deficiency:
- Demographic data - osteoporosis risk factors
- Bone status
- . Once all the data is collected, we will carry out the statistical analyses, then draft the article, and finally publish it.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoporosis with vertebral fracture | Experimental | Diagnostic Test: Plasma vitamin C assessmentBlood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis and recent clincal vertebral fracture. |
| Non-severe osteoporosis | Experimental | Diagnostic Test: Plasma vitamin C assessmentBlood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis without vertebral fracture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men aged 50 yars or older ;
- Postmenopausal women ;
- Afilliated with a health insurance and system ;
- Written informed consent obtained.
- Group 1 : Clincal osteoporotic vertebral fracture confirmed by imaging within the previous month ; Followed in the Rheumatology department for management of vertebral fracture.
Key exclusion criteria (8 listed)
- Legal protection measure (guardianship, curatorship);
- inability to provide informed consent ;
- refusal to participate ;
- Vertebral fracture related to tumor,
- infection, trauma or non osteoporotic causes ;
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 |
|---|---|---|
| Plasma vitamin C assessmentBlood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient of the study | Diagnostic test | Non-severe osteoporosis, Osteoporosis with vertebral fracture |
Primary outcome
Plasma vitamin C concentration
Time frame: day 1
Comparison of plasma vitamin C concentration (ascorbemia, µmol/L) between patients with osteoporotic vertebral fractures and patients with osteoporosis without vertebral fracture.
2 secondary outcomes
Association between plasma vitamin C level and number of vertebral fractures
Time frame: day 1
Association between plasma vitamin C level and lumbar bone mineral density
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma vitamin C assessment in people with Osteoporosis and Vitamin C Deficiency, run by Centre Hospitalier Universitaire de Nice 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-charlotte Trojani, Doctor (0492034702, trojani.mc@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma vitamin C concentration (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 22 Jun 2026.