Sickle Cell DiseaseDREPAN'OSNCT04299594
Prevalence of Osteoporosis in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Questionnaire
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2020to 18 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Black-skinned men and women
- Aged 20 to 40 years old
- Sickle cell patients
- Non-opposition to participate in the study
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or breastfeeding woman
- Psychiatric pathology seriously impeding understanding
- Difficulty understanding oral French
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Questionnaire
- Keywords
- sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start18 Jun 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299594
- Sponsor's protocol ID
- 69HCL20_0142
- Other IDs
- 2020-A00490-39
- Acronym
- DREPAN'OS
- Status last verified
- Feb 2023
- First submitted
- 5 Mar 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Osteoporosis in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04299594
- Acronym / sponsor ID
- DREPAN'OS / 69HCL20_0142
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sickle cell disease patients | – | Other: Questionnaire150 black patients with sickle cell disease living in France, 20 to 40 years old will be included in this study |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Black-skinned men and women
- Aged 20 to 40 years old
- Sickle cell patients
- Non-opposition to participate in the study
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireFor 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. | Other | sickle cell disease patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.