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

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ClinicalTrials.gov Identifier: NCT04299594
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date March 5, 2020
First Posted Date March 9, 2020
Last Update Posted Date July 20, 2020
Actual Study Start Date June 18, 2020
Estimated Primary Completion Date December 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Osteoporosis in Sickle Cell Disease
Official Title Prevalence of Osteoporosis in Sickle Cell Disease
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition 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.
Study Groups/Cohorts 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
Intervention: Other: Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2020)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 18, 2021
Estimated Primary Completion Date December 18, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04299594
Other Study ID Numbers 69HCL20_0142
2020-A00490-39 ( Other Identifier: ID-RDB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date July 2020