NCT07660484

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Jan 2028

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

OsteoporosisVitamin C DeficiencyVertebral Fractures

Outcome Measures

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.

    day 1

Secondary Outcomes (2)

  • Association between plasma vitamin C level and number of vertebral fractures

    day 1

  • Association between plasma vitamin C level and lumbar bone mineral density

    day 1

Study Arms (2)

Osteoporosis with vertebral fracture

EXPERIMENTAL

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

Non-severe osteoporosis

EXPERIMENTAL

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

Diagnostic Test: Plasma vitamin C assessment

Interventions

Plasma vitamin C assessmentDIAGNOSTIC_TEST

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

Non-severe osteoporosisOsteoporosis with vertebral fracture

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

MeSH Terms

Conditions

OsteoporosisAscorbic Acid DeficiencySpinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Marie-charlotte Trojani, Doctor

CONTACT

0492034702trojani.mc@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)