Sickle Cell Disease (SCD) Bone Pain Study

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

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- Oct 2023, and anticipate enrolling 4-6 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05283148
Study type	Interventional
Source	University of California, Davis
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 3, 2022
Completion date	March 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06287502` - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis	N/A
Completed	`NCT03822078` - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women	Phase 1
Recruiting	`NCT05845021` - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04736693` - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting	`NCT06431867` - Primary Care Management of Osteoporosis in Older Women
Completed	`NCT02922478` - Role of Comorbidities in Chronic Heart Failure Study
Recruiting	`NCT02616627` - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Active, not recruiting	`NCT02617303` - Prevention of Falls and Its Consequences in Elderly People	N/A
Completed	`NCT02566655` - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis	Phase 1
Completed	`NCT03420716` - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women	N/A
Not yet recruiting	`NCT02223572` - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture	N/A
Completed	`NCT02559648` - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis	Phase 2
Completed	`NCT02003716` - DeFRA Questionnaire as an Anamnestic Form	N/A
Unknown status	`NCT01913834` - Nasally and sc Administered Teriparatide in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT01854086` - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday	N/A
Completed	`NCT01401556` - C-STOP Fracture Trial	N/A
Completed	`NCT01757340` - Calorie Restriction With Leucine Supplementation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.