- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05283148
Douleur osseuse chez les adultes atteints de drépanocytose
Association entre faible densité osseuse, fractures vertébrales et douleur dans la drépanocytose
A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Sacramento, California, États-Unis, 95817
- UC Davis Comprehensive Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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
Autres noms:
Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA
Autres noms:
Calculate patient-reported total pain scores to determine the pain phenotype of each study participant
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Lumbar Spine Bone Mineral Density
Délai: 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. |
Baseline
|
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Lumbar Spine Bone Mineral Density-Z-scores
Délai: 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. |
Baseline
|
|
Total Hip Bone Mineral Density (BMD)
Délai: 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. |
Baseline
|
|
Total Hip Bone Mineral Density-Z-scores
Délai: 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. |
At enrollment
|
|
Femoral Neck Bone Mineral Density (BMD)
Délai: 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. |
Baseline
|
|
Femoral Neck Bone Mineral Density Z-scores
Délai: 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. |
Baseline
|
|
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores
Délai: 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) |
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Spinal Deformity Index
Délai: 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. |
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Oyebimpe O Adesina, MD, MS, UC Davis School of Medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies osseuses
- Maladies musculo-squelettiques
- Blessures et Blessures
- Processus pathologiques
- Maladies génétiques, innées
- Maladies métaboliques
- Nécrose
- Maladies hématologiques
- Fractures, Os
- Anémie, hémolytique, congénitale
- Anémie, hémolytique
- Anémie
- Hémoglobinopathies
- Blessures au dos
- Blessures à la colonne vertébrale
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladies hémiques et lymphatiques
- Ostéoporose
- Anémie, Drépanocytose
- Maladies osseuses métaboliques
- Ostéonécrose
- Fractures de la colonne vertébrale
- Techniques d'investigation
- Techniques et procédures de diagnostic
- Diagnostic
- Imagerie diagnostique
- Techniques de chimie, analytique
- Radiographie
- Densitométrie
- Photométrie
- Absorptiométrie, photon
Autres numéros d'identification d'étude
- 1782537
- K23HL148310 (Subvention/contrat des NIH des États-Unis)
- 2020095 (Autre subvention/numéro de financement: Doris Duke Charitable Foundation)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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