Summary

Eligibility
for people ages 18-80 (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Oyebimpe O Adesina, MD, MS (ucdavis)

Description

Summary

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Official Title

Association Between Low Bone Density, Vertebral Fractures, and Pain in Sickle Cell Disease

Details

The investigators hypothesize that adults with sickle cell disease (SCD) and low bone density or vertebral compression fractures on a dual X-ray absorptiometry (DXA) scan-adjusted for sex, SCD genotype, vitamin D levels and SCD-modifying therapies-will report more severe pain than those with normal bone density or no vertebral fractures. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) is a validated patient-reported outcome measure of physical, mental, and social health in adults with SCD. This cross-sectional observational study involves obtaining a baseline DXA scan, vertebral fracture analysis (VFA) and pain assessment using ASCQ-Me pain impact scores. The investigators plan to recruit 50 adults with SCD followed at University of California Davis Medical Center between June 2022- September 2023, and anticipate enrolling 2-3 adults with SCD per month. The study endpoints are listed below: - To determine the association between bone density Z-scores and ASCQ-Me pain impact scores in a prospective cohort of adults with SCD - To study the association between Spine Deformity Index scores (SDI, a proxy for vertebral fracture analysis) and ASCQ-Me pain impact scores in a prospective cohort of adults with SCD - To assess the correlation between baseline hematological and biochemical laboratory parameters (including bone biomarkers), bone density, and/or vertebral fractures in a prospective cohort of adults with SCD The investigators' goal is to complete primary data analysis by Dec 2023. As an exploratory endpoint, 1cc of serum and 5cc of urine will be collected from each study participant once (at baseline), after an overnight fast, for bone biomarker analyses.

Keywords

Sickle Cell Disease Low Bone Density Osteonecrosis Avascular Necrosis Sickle Cell Anemia Ischemic Necrosis Vertebra Compression Fracture Vertebral Fracture Vertebral Compression Osteoporosis Osteopenia Bone Diseases, Metabolic Anemia, Sickle Cell Necrosis Fractures, Bone Spinal Fractures Fractures, Compression

Eligibility

You can join if…

Open to people ages 18-80

  • Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)
  • Ability to provide written informed consent
  • Ability to lay on a DXA scanner
  • Negative urine pregnancy test for women of childbearing potential at study entry

You CAN'T join if...

  • Pregnant women
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Hospitalizations (any cause) within 2 weeks of study entry

Lead Scientist at University of California Health

  • Oyebimpe O Adesina, MD, MS (ucdavis)
    Assistant Professor, Hematology and Oncology. Authored (or co-authored) 7 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05283148
Study Type
Observational
Participants
Expecting 50 study participants
Last Updated