Prevalence of Osteoporosis in Sickle Cell Disease

Completed

• Conditions: Sickle Cell Disease
• Interventions: Other: Questionnaire

• Registration Number: NCT04299594
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Study Start: 2020-06-18
• Primary Completion: 2021-12-18
• Study Completion: 2021-12-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Black-skinned men and women
• Aged 20 to 40 years old
• Sickle cell patients
• Non-opposition to participate in the study

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France