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Not yet recruitingNCT07660484ASCOUpdated Jun 22, 2026

Link Between ASCorbemia Level and Osteoporosis

An interventional study of Plasma vitamin C assessment in Osteoporosis, Vitamin C Deficiency and Vertebral Fractures, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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 the 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.
02

Conditions studied

  • Osteoporosis
  • Vitamin C Deficiency
  • Vertebral Fractures
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Osteoporosis with vertebral fracture

    Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis and recent clincal vertebral fracture.

    Diagnostic Test: Plasma vitamin C assessment

  • Experimental
    Non-severe osteoporosis

    Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient with osteoporosis without vertebral fracture.

    Diagnostic Test: Plasma vitamin C assessment

Interventions

  • Diagnostic testPlasma vitamin C assessment

    Blood sampling for measurement of plasma vitamin C concentration (ascorbemia) in patient of the study

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1

Secondary outcomes

  1. 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

    Time frame: day 1

  2. 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.

    Time frame: day 1

06

Study locations

1 site
  • CHU de Nice
    Nice, France 06000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07660484
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Jun 22, 2026

Study contacts

Marie-charlotte Trojani, Doctor
Contact
trojani.mc@chu-nice.fr
0492034702

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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