Link Between ASCorbemia Level and Osteoporosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma vitamin C assessment.
- Who it may be relevant to
- Registry conditions: Osteoporosis, Vitamin C Deficiency, Vertebral Fractures. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ASCO Study: Link Between ASCorbemia Level and Osteoporosis
Overview
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
1. . Patients in group A or B will be seen in consultation or admitted by one of the medical team members among the investigators. 2. . 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. 3. . 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). 4. . Next, the collection of planned clinical and paraclinical data:
* Diet and risk factors for vitamin C deficiency: * Demographic data - osteoporosis risk factors * Bone status 5. . Once all the data is collected, we will carry out the statistical analyses, then draft the article, and finally publish it.
Interventions
- Diagnostic test Plasma vitamin C assessment
Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient of the study
Primary outcome measures
- Plasma vitamin C concentration [Time frame: day 1]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT07660484 · 25-AOI-08 · IDRCB