Association Between Low Bone Density, Vertebral Fractures, and Pain in Sickle Cell Disease
Phase: NA
Conditions: Sickle Cell Disease, Sickle Cell Anemia, Low Bone Density, Osteoporosis, Osteopenia, Vertebral Fracture, Vertebral Compression, Osteonecrosis, Ischemic Necrosis, Avascular Necrosis
Sponsor: University of California, Davis

PROTOCOL TITLE: Association between low bone density, vertebral fractures, and pain in sickle cell 
disease: an observational study 
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1) Protocol Title 
Title:  Association between low bone density, vertebral fractures, and pain in sickle cell 
disease: an observational study 
Protocol Version Date: 05/19/23 
2) Objective 
To determine how low bone mineral density or vertebral compression fractures contribute to pain in a 
prospective cohort of adults with sickle cell disease 
 
3) Background 
Introduction 
Sickle cell disease (SCD) is the most common inherited hemoglobin disorder in the world(1). SCD is 
considered an orphan disease in the United States (US) because it affects less than 200,000 people (2). 
SCD arises from a single nucleotide variant on chromosome 11 that encodes the 𝛽𝛽-globin gene. Under 
stressful physiologic conditions, red blood cells assume rigid, elongated shapes from sickle hemoglobin 
polymerization. Sickle erythrocytes, along with activated white cells and platelets, adhere to the vascular 
endothelium and impair blood flow downstream of the obstruction. Tissue ischemia and infarction ensues, 
eventually leading to end-organ damage (3). Therapeutic interventions like universal newborn screening, 
penicillin prophylaxis, vaccinations against encapsulated organisms, chronic red blood cell transfusions, 
and hydroxyurea therapy have transformed SCD from a genetic disorder with high childhood mortality to 
a chronic illness characterized by progressive pain and end-organ damage (4) . 
 
SCD negatively impacts bone health. The skeletal system is repeatedly injured when recurrent hypoxia-
reperfusion stress induces the release of cytokines that heighten bone resorption (5), while nutritional 
deficits, low muscle mass, delayed puberty and physical inactivity hinder bone formation (6-8). Skeletal 
complications of SCD (9) range from acute vasoocclusive bone pain, bone infarcts and osteomyelitis to 
more chronic manifestations, such as osteonecrosis, osteoporosis and vertebral deformities (10-13). 
Osteonecrosis, in particular, is a major cause of severe chronic SCD pain and significant permanent 
disability (14), which persist even after curative hematopoietic stem cell transplant (15). 
 
Low bone density associates with osteonecrosis of the femoral head (or hip osteonecrosis) and pain 
in pediatric SCD. In collaboration with my 
co-investigators from the Sickle Cell Clinical 
Research 
and 
Intervention 
Program 
(SCCRIP), a lifespan prospective SCD 
cohort maintained at St. Jude Children’s 
Research Hospital (16), we found that low 
bone density independently associates with 
hip osteonecrosis and chronic pain in 
pediatric SCD, see Table 1 (17). Generally, 
SCD complications progressively worsen 
with age. To support our hypothesis that 
therapies that improve bone health may also 
alleviate symptoms of hip osteonecrosis in 
adults, we first need to study the association 
between low bone density, vertebral fractures, 
and pain in a prospective cohort of adults with SCD.  
Table 1. Multivariable regression model of low bone mineral density 
in the SCCRIP pediatric cohort, excerpted from Adesina et al. Blood 
Adv. 2019 May 14;3(9):1476-1488. 

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4) Inclusion and Exclusion Criteria 
All adults with SCD who have received hematology care at UC Davis Medical Center (UCDMC) and non-UC 
Davis facilities will be assessed for potential eligibility. All eligible study participants will undergo a dual 
energy X-ray absorptiometry (DXA) scan to determine their baseline bone mineral density. The DXA 
instrument can also be programmed to obtain morphometric thoracolumbar spine X-ray to evaluate for the 
presence and severity of vertebral compression fractures. In addition to routine study labs, a small aliquout of 
fasting blood and urine samples will be collected from each study participant for biomarker analysis. Routine 
study labs can be drawn up to one week before or after the study visit. Fasting labs for biomarker analysis must 
be collected between 7:30-10am on the day of the study visit to account for changes due to the circadian rhythm. 
 
Inclusion Criteria  
o Age ≥18 years with SCD (any genotype, confirmed by HPLC or hemoglobin electrophoresis)  
o Ability to provide written informed consent 
o Ability to lay on a DXA scanner 
o Negative urine pregnancy test for women of childbearing potential at study entry  
 
Exclusion Criteria 
o Pregnant women 
o Adults unable to consent  
o Individuals who are not yet adults (infants, children, teenagers) 
o Prisoners 
o Hospitalizations  (any cause) within 2 weeks of study entry 
 
 
5) Study Timeline 
This cross-sectional observational study involves obtaining a baseline DXA scan, vertebral fracture 
analysis (VFA) and pain assessment using the Adult Sickle Cell Quality of Life Measurement System 
(ASCQ-Me). We plan to recruit 50 subjects and anticipate enrolling 4 adults with SCD per month from 
Nov 2022– Dec 2023. Our goal is to complete primary data anaylsis by Mar 2024.  
6) Study Endpoints 
• To determine the association between bone density Z-scores and ASCQ-Me pain impact scores 
in adults with SCD. 
• To study the associaton between Spine Deformity Index scores (SDI, a proxy for vertebral 
fracture analysis) and ASCQ-Me pain impact scores in adults with SCD 
• To assess the correlation between baseline hematological and biochemical laboratory parameters; 
including bone biomarkers, and skeletal morbidity in a prospective cohort of adults with SCD 
7) Procedures Involved 
We hypothesize that adults with SCD and low bone density or vertebral compression fractures—adjusted for sex, 
SCD genotype, vitamin D levels and SCD-modifying therapies—will report more severe pain than those with 
normal bone density or no vertebral fractures. ASCQ-Me is a validated patient-reported outcome measure of 

PROTOCOL TITLE: Association between low bone density, vertebral fractures, and pain in sickle cell 
disease: an observational study 
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physical, mental, and social health in adults with SCD (18, 19). For biomarker analyses only, 30cc of whole blood 
and 10cc of urine will be collected from each study participant once (at baseline), after an overnight fast. 
 
Methods: We identified 113 adults with SCD (58% female) 
followed at UCDMC from Oct 2017- Jul 2021. Using the 
National Institutes of Health (NIH) Toolbox iPad App, we 
will electronically administer the ASCQ-Me pain domain 
questionnaire to 50 ambulatory adults with SCD and securely 
store their responses on the Research Electronic Data Capture 
System (REDCap).  
 
ASCQ-Me uses a T-score metric with a mean score of 50 for 
the reference population and a standard deviation (SD) of 10. 
We hypothesize that ASCQ-Me pain impact scores will 
directly correlate with lumbar spine, hip, forearm, or whole 
body bone density Z-scores;  and inversely correlate with SDI 
scores (Figure 1). 
 
Potential Problems/Alternative Strategies. Recruiting and 
retaining 50 adults with SCD is feasible within the study 
period. As previously noted, I am a co-investigator and co-
chair the Bone Working Group in SCCRIP, the longitudinal 
study of 1300 children and adults with SCD maintained at St. 
Jude Children’s Research Hospital.  In the unlikely event that 
we are unable to recruit all 50 participants from UCDMC and 
non-UC Davis facilities, we will extend our study recruitment 
to include eligible adult participants  from the SCCRIP 
cohort. For study participants who are not comfortable with 
using research iPads, we plan to administer the ASCQ-Me pain 
questions on paper in standard (13 questions) or short form (5 
questions).  A copy of the ASCQ-Me Pain Impact short form is excerpted below: 
 
Figure 1. Study schema 

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8) Data and/or Specimen Management and Confidentiality 
☒ I understand that if this study involves the use of  the UC Davis Health Electronic Health 
Record (EMR/EPIC), which also contains the clinical data for Marshall Medical Center (MMC). 
I understand that MMC patient data cannot be accessed for research purposes and that I must 
take the necessary steps to ensure that MMC data is not accessed, used, or disclosed for UC 
Davis Health research purposes. 
☐ I undersand that if this study involves use of UC Davis students’ educational records 
(including records in the PI’s own possession such as course exams/assignments), I must consult 
with the Registrar’s office to see if all requirements of the Family Educational Rights and 
Privacy Act (FERPA) are satisfied.  N/A 
 
Data analysis plan and Power calculations: 
To test the association between ASCQ-Me pain scores and bone density Z-scores, we will build a linear regression 
model with ASCQ-Me pain scores as the outcome of interest and bone density Z-scores as an independent 
variable. We will repeat the analysis using SDI scores and laboratory parameters as independent variables.  We 
will further adjust for potential confounders, such as age, sex, SCD genotype, vitamin D levels and SCD-
modifying therapies i.e, hydroxyurea use or chronic red blood cell transfusions. Then, we will add osteonecrosis 
in any joint (yes vs no) into the linear regression model to test the interaction between osteonecrosis and low bone 
density on ASCQ-Me pain scores, adjusted for the previously mentioned covariates. We will also test for the 
interaction between osteonecrosis and vertebral fractures on ASCQ-Me pain scores. For statistical power 
calculations only, we will categorize study subjects as being in group A (low bone density or vertebral 
compression fractures) and group B (normal bone density or no vertebral fractures) to better estimate the 
differences in pain scores observed between both groups. If we assume 50% prevalence of low bone density or 
vertebral fractures in adults with SCD ((12)18-20), then 50% of our study subjects will fall in group A and group 
B. If we assume mean pain scores of 40 in group A (i.e., one SD worse than the average population) and mean 
pain scores of 50 in group B (population mean), then enrolling 40 adults with SCD provides approximately 80% 
power to detect a statistically significant and clinically useful difference in ASCQ-Me pain impact scores between 
groups A and B (2-sided, alpha of 0.05; SD 10). We will enroll an additional 10 adults to account for study 

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discontinuations and to support exploratory endpoints e.g., interaction between low bone mineral density or 
vertebral compression fractures, osteonecrosis, and sickle cell pain. 
Procedures for maintenance and confidentiality: 
• This research study will include a Partial Waiver of HIPAA Authorization for participant 
identification and recruitment through medical chart review.  
• A signed HIPAA Authorization will be required for access, use, or disclosure of identifiable 
private information for participation in research activities. 
• All study data will be securely stored on password-protected REDCap system, which can 
only be accessed through institutional computers with encryption.  
• The PI and research coordinator will complete a weekly audit to ensure all study data are 
collected/securely stored until study completion. 
9) Data and/or Specimen Banking:  
All patient data and biospecimens will be securely stored for at least 5 years after study 
completion to allow time for full data analyses. 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
Every research team member will complete training in the Human Research Protections and Good Clinical 
Practice for Clinical Trials with Investigational Drugs and Biologics, through the Collaborative 
Institutional Training Initiative (CITI Program).  The PI will monitor all research activities. The research 
will also be regulated by UC Davis’s Institutional Review Board (IRB). The written consent forms include 
24-hour physician contact information for any study-related emergencies. Any protocol deviations or 
study participants’ safety concerns will be promptly reported to the UC Davis IRB and to the study 
sponsors. 
 
11) Withdrawal of Subjects 
The principal investigator (PI) is a board-certified hematologist with expertise in sickle cell 
disease, who will oversee all research activities and closely review all reported adverse events with 
the clinical research staff.  
12) Risks to Subjects 
The proposed research study confers minimal risk of harm to the study participants. SCD patients enrolled 
in the study will undergo a DXA scan to measure their bone mineral density, which will expose them to 
small doses of ionizing radiation with attendant risk.  While still in the DXA scanner, they will be 
repositioned to obtain a lateral thoracolumbar spine X-ray for vertebral fracture analyses (VFA). The 
amount of radiation exposure received from the DXA and VFA scans fall below levels that are thought to 
result in a significant risk of harmful effects.They will also be asked to give blood and urine samples for 
biomarker analysis, and fill out the ASCQ-Me pain impact questionnaire. 
 
Dual energy X-ray absorptiometry (DXA): We will perform one DXA scan for this study. Study 
participants will be exposed to a very small amount of X-ray radiation ( less than 0.01mSV) during the 
DXA procedure(20). There are no known risks associated with radiation exposure levels this low. There 
may be some side effects with repeated exposure to radiation, including an increased risk of cancer. 
However, exposure to doses several thousand times greater than that obtained from this study would be 
required before an increased risk of cancer could be detected. Thus, the radiation exposure from this 
procedure represents a negligible health risk. Pregnancy testing will be performed prior to the DXA scan. 

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Study subjects may experience discomfort while being positioned on the DXA scanner. The exercise 
physiologist conducting the study is well trained and will be instructed to position study subjects as quickly 
as possible to minimize any physical discomfort.  
 
Vertebral fracture analysis (VFA): The DXA machine can be programmed to obtain a lateral spine X-
ray of VFA scan. Similar to the DXA scan, patietns will be exposed to a very small amount of X-ray 
radiation (0.05 mSV) during the VFA scan (20). There are no known risks associated with radiation 
exposure levels this low. There may be some side effects with repeated exposure to radiation, including 
an increased risk of cancer. However, exposure to doses several thousand times greater than that obtained 
from this study would be required before an increased risk of cancer could be detected. Thus, the radiation 
exposure from this procedure represents a negligible health risk. As above, pregnant patients will not 
undergo a VFA scan. The exercise physiologist conducting the study will reposition study subjects in the 
DXA scanner as quickly and as comfortably as possible to minimize any discomfort from this additional 
scan. 
 
Specimen collection: The needle stick from a venipuncture (blood draw) may hurt. There is a small risk 
of bruising and fainting, and a rare risk of infection. Some SCD patients have indwelling port catheters 
for vascular access, which may also be used for blood collection. Venipuncture or accessing a port may 
be temporarily uncomfortable. Urine sample collection might also be inconvenient for some patients. 
 
 
13) Potential Benefits to Subjects 
We do not anticipate any direct benefits to study participants. If any study participant is found to have 
osteoporosis (a severe form of bone loss) on the DXA scan, they will be referred for additional work-up 
and appropriate treatment.  
 
14) Multi-Site Research: N/A 
 
15) Community-Based Participatory Research: N/A 
 
16) Sharing of Results with Subjects 
Study results may be shared with subjects, upon request.  Dr. Adesina (PI) will present preliminary and 
final results of all aspects of her proposed study at local and national meetings, including the NHLBI 
Annual Sickle Cell Clinical Research Meeting and the American Society of Hematology annual research 
meeting. She will publish her findings in peer-reviewed journals and share the results with the public 
through SCD advocacy groups and organizations.  
 
17) Prior Approvals 
This research is being funded by the National Institutes of Health/National Heart, Lung and Blood 
Institute (NIH/NHLBI) and the Doris Duke Charitable Foundation (DDCF), who will provide 
additional research oversight.  
 

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18) Provisions to Protect the Privacy Interests of Subjects 
This study confers minimal risk of a confidentiality breach. We will apply appropriate data 
security measures to prevent unauthorized access to individually identifiable data 
19) Compensation for Research-Related Injury 
This study confers minimal risk of research-related injury as the DXA scan related to the study 
will only expose study participants to minimal radiation. Given the limited scope of this 
observational study, the University of California and the study Sponsors will cover any necessary 
medical treatment for study-related injuries, but they will not provide any other form of 
compensation for study-related injuries.   
 
20) Economic Burden to Subjects 
Study participants will be compensated $100 for their time and effort. They may be asked for their 
social security number for payment purposes. It will not be used for any other purpose without 
their permission. In addition to the $100 compensation, all study participants will be reimbursed 
for mileage (travel to and from study visit) parking, and other travel-related expenses for this 
research study visit. Since study participants will be fasting for the study, they will also be offered 
a meal voucher to use at the UCDMC cafeteria after their study visit. 
 
21) Drugs or Devices 
☐ I confirm that all investigational drugs will be received by the Investigational Drug Service 
(IDS).  The IDS will store, handle, and administer those drugs so that they will be used only on 
subjects and be used only by authorized investigators. N/A 
 
☐ I confirm that all investigational devices will be labelled in accordance with FDA regulations and 
stored and dispensed in such a manner that they will be used only on subjects and be used only by 
authorized investigators. N/A 
 
22) Review Requirements 
        Are there any contractual obligations or other considerations that require IRB 
review of this research, or review at intervals other than those required by the 
Common Rule or FDA? If yes, check box: 
 
 Yes 
 
x No 
 
 
 
 
 
 
 
 

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