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Prevalence of Osteoporosis in Sickle Cell Disease (DREPAN'OS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04299594
Recruitment Status : Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Osteoporosis in Sickle Cell Disease
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
sickle cell disease patients
120 black patients with sickle cell disease living in France, 20 to 40 years old will be included in this study
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299594


Contacts
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Contact: CHAPURLAT Roland, PU, PH 04 72 11 74 82 ext +33 roland.chapurlat@chu-lyon.fr
Contact: MERLE Blandine 04 72 11 74 80 ext +33 blandine.merle@inserm.fr

Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69437
Contact: CHAPURLAT Roland, PU,PH    04 72 11 74 82 ext +33    roland.chapurlat@chu-lyon.fr   
Contact: MERLE Blandine    04 72 11 74 80 ext +33    blandine.merle@inserm.fr   
Principal Investigator: CHAPURLAT Roland, PU,PH         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04299594    
Other Study ID Numbers: 69HCL20_0142
2020-A00490-39 ( Other Identifier: ID-RDB )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
sickle cell disease
Additional relevant MeSH terms:
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Osteoporosis
Anemia, Sickle Cell
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn