Prevalence of Osteoporosis in Sickle Cell Disease

NCT ID: NCT04299594

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-18

Study Completion Date

2021-12-18

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00490-39

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0142

Identifier Type: -

Identifier Source: org_study_id

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