NCT05283148

Sickle Cell Disease (SCD) Bone Pain Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

The investigators hypothesize that adults with sickle cell disease (SCD) and low bone density and/or vertebral compression fractures on a dual X-ray absorptiometry (DXA) scan (adjusted for age, sex, SCD genotype, relevant labs, presence of osteonecrosis, 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 Nov 2022- Dec 2023 and anticipate enrolling up to 4 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 Mar 2024. 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.

Conditions

• Sickle Cell Disease
• Sickle Cell Anemia
• Low Bone Density
• Osteoporosis
• Osteopenia
• Vertebral Fracture
• Vertebral Compression
• Osteonecrosis
• Ischemic Necrosis
• Avascular Necrosis

Interventions

Type	Name	Description
OTHER	Dual-energy X-ray absorptiometry	Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body
OTHER	Vertebral fracture analysis	Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA
OTHER	Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire	Calculate patient-reported total pain scores to determine the pain phenotype of each study participant

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-04-30
• Completion: 2026-07-31
• First posted: 2022-03-16
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

1 site across 1 country: United States