Prevalence of Osteoporosis in Sickle Cell Disease

NCT04299594 | Completed

• 2 other identifiers: 69HCL20_01422020-A00490-39
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Keywords

sickle cell disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Questionnaire OTHER

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.

sickle cell disease patients

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

sickle cell adult patients hospitalized (conventional or day hospitalization) or followed in consultation in internal medicine within the framework of their sickle cell disease at Edouard Herriot Hospital, Lyon, France

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69437, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: June 18, 2020
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

FR (1)