DREPAN'OS: Prevalence of Osteoporosis in Sickle Cell Disease

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04299594
Collaborator
(none)
150
1
18
8.3

Study Details

Study Description

Brief Summary

Sickle cell disease is the most common single-gene disease in the world. Its prevalence is increasing in France, with patients' life expectancy increasing into developed countries. It mainly affects populations originating from sub-Saharan Africa. Among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. A dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in France may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in France

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prevalence of Osteoporosis in Sickle Cell Disease
Actual Study Start Date :
Jun 18, 2020
Anticipated Primary Completion Date :
Dec 18, 2021
Anticipated Study Completion Date :
Dec 18, 2021

Arms and Interventions

Arm Intervention/Treatment
sickle cell disease patients

150 black patients with sickle cell disease living in France, 20 to 40 years old will be included in this study

Other: Questionnaire
For each subject recruited, will be collected for the study a questionnaire looking for a history of low energy fracture, and the origins of the patient (or relatives), as well as medical history, lifestyle (alcohol and tobacco consumption), weight and height. This data will be used for the secondary outcomes.

Outcome Measures

Primary Outcome Measures

  1. Bone mineral density [Day 1]

    Bone mineral density is measured by systematic bone densitometry at 3 sites: lumbar spine, femoral neck and total hip. These data will be collected in the patient's medical record

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Black-skinned men and women

  • Aged 20 to 40 years old

  • Sickle cell patients

  • Non-opposition to participate in the study

Exclusion Criteria:
  • Refusal to participate in the study

  • Hemoglobinopathy other than sickle cell disease

  • Severe or End Stage Renal Failure

  • Long-term corticosteroid therapy (>3 months)

  • History of solid cancer or malignant haemopathy

  • History of organ transplantation

  • Pregnant or breastfeeding woman

  • Psychiatric pathology seriously impeding understanding

  • Difficulty understanding oral French

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Edouard Herriot Lyon France 69437

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04299594
Other Study ID Numbers:
  • 69HCL20_0142
  • 2020-A00490-39
First Posted:
Mar 9, 2020
Last Update Posted:
Dec 29, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2021