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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL148310 | U.S. NIH Grant/Contract | View source | |
| 2020095 | Other Grant/Funding Number | Doris Duke Charitable Foundation |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Doris Duke Charitable Foundation | OTHER |
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A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-energy X-ray absorptiometry | Other | Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Deformity Index | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oyebimpe O Adesina, MD, MS | UC Davis School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41135058 | Derived | Adesina OO, Voutsinas J, Wu QV, Teos LY, Rokni M, Nalbant H, Nardo L, Wun T, Zemel B. Low bone mineral density and pain impact in adults with sickle cell disease. Blood Adv. 2026 Feb 10;10(3):748-758. doi: 10.1182/bloodadvances.2025015957. |
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From this convenience sample of 128 SCD adults, 72 were approached to participate in the study, and 53 participants eventually enrolled in the SCD Bone Pain study
One hundred and twenty-eight unique adults (age 18 years and older) with SCD of any genotype seen in the Adult Sickle Cell clinic at UCD's Comprehensive Cancer Center between 2022-2023 were eligible to participate in the SCD Bone Pain study.
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| ID | Title | Description |
|---|---|---|
| FG000 | SCD Bone Pain Study Cohort | The SCD Bone Pain study was a single-arm, prospective, observational cohort study of 53 adults with sickle cell disease (SCD) undergoing research DXA scans to assess bone mineral density, thoracolumbar morphometry for vertebral fracture analyses, and ASC-Me pain impact assessment. Definitions: Dual-energy X-ray absorptiometry (DXA) scan: Used to measure bone mineral density at the lumbar spine, total hip, forearm, and whole body Vertebral fracture analysis (VFA): Obtained from thoracolumbar morphometry in DXA scanner, then grade presence and severity of vertebral compression fractures using spinal deformity index Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) pain impact questionnaire: Calculate patient-reported total pain scores to determine the pain phenotype of each study participant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2023 |
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Prospective cohort study
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| Vertebral fracture analysis | Other | Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA |
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| 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 |
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| 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 |
| Baseline |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SCD Bone Pain Study Cohort | Prospective cohort of 53 adults with sickle cell disease (SCD) to assess the following:
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| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years) at study visit date | Median | Full Range | Years |
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| Sex: Female, Male | Patient-reported sex (at birth) obtained on study visit date | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Height | Participant height measured on study visit date | Median | Full Range | cm |
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| Body mass index (BMI) | BMI as of study visit date | Median | Full Range | kg/m2 |
| ||||||||||||||||
| Sickle cell disease (SCD) genotype | SCD genotype confirmed by hemoglobin electrophoresis or hemoglobin analysis | Count of Participants | Participants | No |
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| Osteonecrosis | Number of participants with radiographically confirmed osteonecrosis at study entry | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | g/cm2 | Baseline |
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| Primary | 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. | Posted | Median | Full Range | Z-score | Baseline |
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| Primary | 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. | Posted | Median | Full Range | g/cm2 | Baseline |
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| Primary | 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. | Posted | Median | Full Range | Z-score | At enrollment |
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| Primary | 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. | Posted | Median | Full Range | g/cm2 | Baseline |
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| Primary | 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. | Posted | Median | Full Range | Z-score | Baseline |
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| Primary | 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) | Posted | Median | Inter-Quartile Range | T-score | Baseline |
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| Secondary | Spinal Deformity Index | 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. | Statistical analysis of spinal deformity index is ongoing. Complete results will be provided by February 2026. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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13 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCD Bone Pain Study Cohort | Prospective cohort of 53 adults with sickle cell disease (SCD) undergoing research DXA scan to assess bone mineral density and thoracolumbar morphometry for vertebral fracture analysis Dual-energy X-ray absorptiometry: Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body Vertebral fracture analysis: Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA 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 | 0 | 53 | 0 | 53 | 0 | 53 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oyebimpe Adesina, MD, MS | University of California Davis Comprehensive Cancer Center | 9167035166 | adesina@ucdavis.edu |
| Apr 1, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2023 | Apr 1, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D016103 | Spinal Fractures |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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