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- Klinische proef NCT05283148
Botpijn bij volwassenen met sikkelcelziekte
Associatie tussen lage botdichtheid, wervelfracturen en pijn bij sikkelcelziekte
A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Sacramento, California, Verenigde Staten, 95817
- UC Davis Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: SCD Bone Pain Study Cohort
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 |
Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body
Andere namen:
Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA
Andere namen:
Calculate patient-reported total pain scores to determine the pain phenotype of each study participant
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lumbar Spine Bone Mineral Density
Tijdsspanne: Baseline
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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
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Lumbar Spine Bone Mineral Density-Z-scores
Tijdsspanne: Baseline
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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
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Total Hip Bone Mineral Density (BMD)
Tijdsspanne: Baseline
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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
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Total Hip Bone Mineral Density-Z-scores
Tijdsspanne: At enrollment
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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
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Femoral Neck Bone Mineral Density (BMD)
Tijdsspanne: Baseline
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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
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Femoral Neck Bone Mineral Density Z-scores
Tijdsspanne: Baseline
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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
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Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores
Tijdsspanne: Baseline
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Spinal Deformity Index
Tijdsspanne: Baseline
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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. |
Baseline
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Oyebimpe O Adesina, MD, MS, UC Davis School of Medicine
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Botziekten
- Musculoskeletale aandoeningen
- Wonden en verwondingen
- Pathologische processen
- Genetische ziekten, aangeboren
- Metabole ziekten
- Necrose
- Hematologische ziekten
- Breuken, bot
- Bloedarmoede, hemolytisch, aangeboren
- Bloedarmoede, hemolytisch
- Bloedarmoede
- Hemoglobinopathieën
- Rugblessures
- Letsel aan de ruggengraat
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Hemische en lymfatische ziekten
- Osteoporose
- Bloedarmoede, sikkelcel
- Botziekten, Metabool
- Osteonecrose
- Wervelkolom fracturen
- Onderzoekstechnieken
- Diagnostische technieken en procedures
- Diagnose
- Diagnostische beeldvorming
- Chemie -technieken, analytisch
- Radiografie
- Densitometrie
- Fotometrie
- Absorptiometrie, foton
Andere studie-ID-nummers
- 1782537
- K23HL148310 (Subsidie/contract van de Amerikaanse NIH)
- 2020095 (Ander subsidie-/financieringsnummer: Doris Duke Charitable Foundation)
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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