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OpenTrials
Completed

NCT Number: NCT04299594

Prevalence of Osteoporosis in Sickle Cell Disease

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

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Bone mineral density

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DREPAN'OS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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