Prevalence of Osteoporosis in Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— DREPAN'OS  

Official title:

Prevalence of Osteoporosis in Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299594
• Other study ID #: 69HCL20_0142
• Secondary ID: 2020-A00490-39
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: December 18, 2021

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Osteoporosis
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	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	Day 1