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Active, Not Recruiting

NCT Number: NCT05283148

Sickle Cell Disease (SCD) Bone Pain Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Avascular Necrosis Back Injuries Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fractures, Bone Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Ischemic Necrosis Low Bone Density Metabolic Diseases Musculoskeletal Diseases Necrosis Nutritional and Metabolic Diseases Osteonecrosis Osteopenia Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sickle Cell Anemia Spinal Fractures Spinal Injuries Vertebral Compression Vertebral Fracture Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-energy X-ray absorptiometry

Other

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

Other names: DXA scan

Vertebral fracture analysis

Other

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

Other names: VFA

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

Other names: ASCQ-Me Pain scores

Primary outcomes

  1. Lumbar Spine Bone Mineral Density

    Time frame: Baseline

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

  2. Lumbar Spine Bone Mineral Density-Z-scores

    Time frame: Baseline

    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.

  3. Total Hip Bone Mineral Density (BMD)

    Time frame: Baseline

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

  4. Total Hip Bone Mineral Density-Z-scores

    Time frame: At enrollment

    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.

  5. Femoral Neck Bone Mineral Density (BMD)

    Time frame: Baseline

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

  6. Femoral Neck Bone Mineral Density Z-scores

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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)

Secondary outcomes

  1. Spinal Deformity Index

    Time frame: Baseline

    The spinal deformity index (SDI) is a semi-quantitative measure of number and severity of vertebral fractures observed on lateral spine X-rays of the thoracolumbar spine. To calculate the SDI, vertebrae are assigned a score as follows: 0 (no fracture), 1 (mild fracture), 2 (moderate fracture), and 3 (severe fracture). The total SDI is the summation of all T12-L4 vertebrae measured on the lateral spine X-rays. Minimum SDI =0 and Maximum SDI=15. Higher scores mean increased (worse) fracture burden, lower scores mean decreased (less) fracture burden.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Doris Duke Charitable Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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