Sickle Cell DiseaseNCT05283148

Sickle Cell Disease (SCD) Bone Pain Study

A study testing Dual-energy X-ray absorptiometry, Vertebral fracture analysis and Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire in people with Sickle Cell Disease and Sickle Cell Anemia, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sickle Cell Disease, Sickle Cell Anemia, Low Bone Density
What is being tested?: Dual-energy X-ray absorptiometry, Vertebral fracture analysis and Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 3 Nov 2022to 31 Dec 2027
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis Comprehensive Cancer Center
Sacramento, California, 95817

Other trials in United States

About this study

Official title: Association Between Low Bone Density, Vertebral Fractures, and Pain in Sickle Cell Disease

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Read the detailed 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- 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.

Conditions: Sickle Cell Disease, Sickle Cell Anemia, Low Bone Density, Osteoporosis, Osteopenia, Vertebral Fracture
Being tested: Dual-energy X-ray absorptiometry, Vertebral fracture analysis, Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire
Keywords: sickle cell disease, sickle cell anemia, low bone density, osteoporosis, osteopenia, low bone mass
Medical subject headings: Anemia, Sickle Cell, Bone Diseases, Metabolic, Osteoporosis, Spinal Fractures, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual-energy X-ray absorptiometryOther
Also called DXA scan
Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body
Vertebral fracture analysisOther
Also called VFA
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 questionnaireOther
Also called ASCQ-Me Pain scores
Calculate patient-reported total pain scores to determine the pain phenotype of each study participant

Study groups in NCT05283148
Study group	Role	What they receive
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 Receives: Other: Dual-energy X-ray absorptiometry; Other: Vertebral fracture analysis; Other: Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
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.
Measured: 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)
Measured: Baseline

Secondary outcomes (1)

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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202231 Dec 2027

First posted16 Mar 2022
Study start3 Nov 2022
Primary completion30 Apr 2024
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective cohort study
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05283148
Sponsor's protocol ID: 1782537
Other IDs: K23HL148310, 2020095
Status last verified: Aug 2026
First submitted: 7 Mar 2022
Last updated: 23 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41135058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
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Myeloid Chimerism
Not yet recruitingObservational study
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All Sickle Cell Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association Between Low Bone Density, Vertebral Fractures, and Pain in Sickle Cell Disease
ClinicalTrials.gov ID: NCT05283148
Acronym / sponsor ID: 1782537
Conditions: Sickle Cell Disease, Sickle Cell Anemia, Low Bone Density, Osteoporosis, Osteopenia, Vertebral Fracture
Keywords: sickle cell disease, sickle cell anemia, low bone density, osteoporosis, osteopenia, low bone mass
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 53 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Doris Duke Charitable Foundation
Study start: 3 Nov 2022 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 31 Dec 2027 (estimated)
First posted: 16 Mar 2022 (actual)
Results: Posted 24 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Detailed description

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

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective cohort study

Arm	Type	Receives
SCD Bone Pain Study Cohort	Other	Other: Dual-energy X-ray absorptiometry, Other: Vertebral fracture analysis, Other: Adult Sickle Cell Quality of Life Measurement System pain impact questionnaireProspective 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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual-energy X-ray absorptiometryAlso: DXA scanMeasure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body	Other	SCD Bone Pain Study Cohort
Vertebral fracture analysisAlso: VFAObtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA	Other	SCD Bone Pain Study Cohort
Adult Sickle Cell Quality of Life Measurement System pain impact questionnaireAlso: ASCQ-Me Pain scoresCalculate patient-reported total pain scores to determine the pain phenotype of each study participant	Other	SCD Bone Pain Study Cohort

Primary outcome

Lumbar Spine Bone Mineral Density
Time frame: 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.
Lumbar Spine Bone Mineral Density-Z-scores
Time frame: 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.
Total Hip Bone Mineral Density (BMD)
Time frame: 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.
Total Hip Bone Mineral Density-Z-scores
Time frame: 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.
Femoral Neck Bone Mineral Density (BMD)
Time frame: 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.
Femoral Neck Bone Mineral Density Z-scores
Time frame: 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.
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores
Time frame: 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)

1 secondary outcome

Spinal Deformity Index
Time frame: Baseline

Results and safety

Results posted to the registry on 24 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCD Bone Pain Study Cohort	53	53

Primary outcome: Lumbar Spine Bone Mineral Density

Time frame: Baseline. Median (Full Range). Unit: g/cm2

Measure	Group A n = 34	Group B n = 19
Value	0.97 (0.62 to 1.31)	1.0 (0.72 to 1.67)

Group A vs Group B: p = 0.321, Wilcoxon rank-sum test (two-sided)

Primary outcome: Lumbar Spine Bone Mineral Density-Z-scores

Time frame: Baseline. Median (Full Range). Unit: Z-score

Measure	Group A n = 34	Group B n = 19
Value	-1.35 (-4.40 to 1.60)	-1.60 (-4.30 to 4.30)

Group A vs Group B: p = 0.714, Welch two sample t-test

Primary outcome: Total Hip Bone Mineral Density (BMD)

Time frame: Baseline. Median (Full Range). Unit: g/cm2

Measure	Group A n = 34	Group B n = 19
Value	0.90 (0.66 to 1.34)	1.03 (0.67 to 1.76)

Group A vs Group B: p = 0.09, Wilcoxon rank-sum test (two-sided)

Primary outcome: Total Hip Bone Mineral Density-Z-scores

Time frame: At enrollment. Median (Full Range). Unit: Z-score

Measure	Group A n = 34	Group B n = 19
Value	-0.75 (-2.30 to 2.00)	-0.5 (-2.7 to 3.5)

Group A vs Group B: p = 0.604, Welch two sample t-test (two sided)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 13 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCD Bone Pain Study Cohort	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41135058Adesina 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oyebimpe O Adesina, MD, MS principal investigator

UC Davis School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lumbar Spine Bone Mineral Density (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05283148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.