Sickle Cell Disease (SCD) Bone Pain Study

University of California (UC) Davis

Status: Active, not recruiting

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

Treatments: Other: Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire; Other: Dual-energy X-ray absorptiometry; Other: Vertebral fracture analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05283148

1782537

2020095 (Other Grant/Funding Number)

K23HL148310 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

SCD Bone Pain Study Cohort

Other group

Description:

Prospective cohort of 50 adults with sickle cell disease (SCD) undergoing research DXA scan to assess bone mineral density and thoracolumbar morphometry for vertebral fracture analysis

Treatment:

Other: Vertebral fracture analysis

Other: Dual-energy X-ray absorptiometry

Other: Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire