Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.

Sickle Cell Disease Clinical Trial

— OsteoSCD  

Official title:

Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203991
• Other study ID #: Osteonecrosis SCD
• Status: Completed
• Start date: March 18, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: January 2022
• Source: San Luigi Gonzaga Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger for additional VOC.

In this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in Italy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Female or male patients diagnosed with sickle cell anemia (HbSS, HbS/ß0, HbS/ß+, HbSC) with or without known avascular lesions

• Age = 7 and < 18 years at the moment of signed consent

• Written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian

Exclusion Criteria:

• - Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI)

• Inability to obtain informed consent/assent

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
Italy	AOU San Luigi Gonzaga	Orbassano	Torino

Sponsors (1)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate the prevalence of unknown osteonecrosis	Avascular necrosis of the bones are diagnosed by systematic MRI at sites: total spine, femurs, shoulders, humeri and total hip. These data will be collected in the patient's medical record in patients with sickle cell anemia regardless of the number and intensity of vaso-occlusive crisis	Day 1