Sickle Cell Disease (SCD) Bone Pain Study

NCT05283148 | Active Not Recruiting Results DMC

• 3 other identifiers: 1782537K23HL1483102020095
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

sickle cell disease; sickle cell anemia; low bone density; osteoporosis; osteopenia; low bone mass

Outcome Measures

Primary Outcomes (7)

• Lumbar Spine Bone Mineral Density

  Areal bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.

  Baseline

• Lumbar Spine Bone Mineral Density-Z-scores

  Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.

  Baseline

• Total Hip Bone Mineral Density (BMD)

  Areal bone mineral density of the total hip measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.

  Baseline

• Total Hip Bone Mineral Density-Z-scores

  Number of standard deviations between measured total hip bone mineral density (g/cm2) for each participant and mean total hip bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.

  At enrollment

• Femoral Neck Bone Mineral Density (BMD)

  Areal bone mineral density of the femoral neck measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.

  Baseline

• Femoral Neck Bone Mineral Density Z-scores

  Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.

  Baseline

• Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores

  Patient-reported outcome measure of pain impact in the preceding 7 days before bone density measurements. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) pain impact T-scores range from about 30-100. The ASCQ-Me pain impact T-score has standardized mean T-score of 50 and standard deviation of 10, which were derived from a reference population of ambulatory adult with sickle cell disease across the United States. ASCQ-Me pain impact T-scores less than 50 are lower/worse than the reference mean (more severe pain impact), while pain impact T-scores greater than 50 are above/better than the reference mean (less severe pain impact)

  Baseline

Secondary Outcomes (1)

• Spinal Deformity Index

  Baseline

Study Arms (1)

SCD Bone Pain Study Cohort

OTHER

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

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

Interventions

Dual-energy X-ray absorptiometry OTHER

Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body

Also known as: DXA scan

SCD Bone Pain Study Cohort

Vertebral fracture analysis OTHER

Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA

Also known as: VFA

SCD Bone Pain Study Cohort

Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire OTHER

Calculate patient-reported total pain scores to determine the pain phenotype of each study participant

Also known as: ASCQ-Me Pain scores

SCD Bone Pain Study Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Adesina O, Voutsinas JM, Wu QV, Teos LY, Rokni M, Nalbant H, Nardo L, Wun T, Zemel BS. Low bone mineral density and pain impact in adults with sickle cell disease. Blood Adv. 2025 Oct 24:bloodadvances.2025015957. doi: 10.1182/bloodadvances.2025015957. Online ahead of print.

  PMID: 41135058 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Bone Diseases, Metabolic; Osteoporosis; Spinal Fractures; Osteonecrosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

This prospective study on the association between bone density and pain in SCD is limited by its cross-sectional study design and small sample size. We can only report associations between the predictor variables and outcomes of interest, not causality. Since joint imaging was only done based on symptoms, we may have missed participants with asymptomatic osteonecrosis. Lastly, DXA scans are widely used to clinically assess severe low BMD but cannot differentiate trabecular vs cortical bone loss.

Results Point of Contact

• Title: Oyebimpe Adesina, MD, MS
• Organization: University of California Davis Comprehensive Cancer Center

adesina@ucdavis.edu

9167035166

Study Officials

• Oyebimpe O Adesina, MD, MS

  UC Davis School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: November 3, 2022
• Primary Completion: April 30, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)