Glomerular DiseaseBoneGNNCT04528446
The Impact of Glomerular Disorders on Bone Quality and Strength
An observational study of Glomerular Disease and Bone Diseases, Metabolic, run by Columbia University at 2 sites in United States.
Trial summary
The primary objectives of this study are to: (1) determine the impact of glomerular disease on bone strength and (2) investigate the pathophysiologic underpinnings of impaired bone strength in glomerular disease. Read more about this study
- Who is it for?
- Ages 5 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glomerular Disease, Bone Diseases, Metabolic, Bone Fracture
- What is being tested?
- Dual-energy X-ray absorptiometry, High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) and Blood draw and Urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Prospective cohort study of 150 CureGN participants (100 adults/50 children) will be evaluated at baseline and 12 months. The CureGN DCC at Arbor Research will identify CureGN participants eligible for inclusion. Recruitment of healthy participants will also occur by leveraging the services of the CHOP Recruitment Enhancement Core (REC), Pediatric Research Consortium (PeRC) and the RecruitMe tool provided by the Clinical Trials Office at CUMC. Healthy adult controls will be recruited from patients who receive outpatient care within the Penn Primary Care Networks, Penn employees and students, an extensive database of individuals who have participated in prior research studies at Penn and through local advertising on the Penn campus.
Who may be able to join
None listed.
Who cannot join
- Chronic Dialysis
- Solid organ transplantation
- Lower extremity amputations or non-ambulatory
- Malignancy requiring chemotherapy or metastatic to bone
- Metabolic bone disease (e.g., Paget's disease, primary hyperparathyroidism)
- Endocrinopathy (current hyperthyroidism or untreated hypothyroidism, Cushing's syndrome)
Show all 11Show fewer
- Medical diseases (end stage liver disease, heart or lung disease, intestinal malabsorption)
- Those treated with bisphosphonates, teriparatide, calcitonin, selective estrogen receptor modulators, estrogen, or phenytoin in the past 12 months
- Previous bilateral wrist and tibia fractures
- Pregnant or lactating females
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Maria A. Aponte, 212-342-4678, maa2308@cumc.columbia.edu
Thomas L. Nickolas, MD
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Erin Doherty, 267-600-6233, dohertye@email.chop.edu
Michelle R. Denburg, MD
About this study
The primary objectives of this study are to: (1) determine the impact of glomerular disease on bone strength and (2) investigate the pathophysiologic underpinnings of impaired bone strength in glomerular disease.
Read the detailed description
Children and adults with glomerular disease have unique and potentially modifiable risk factors for compromised bone health, but our current understanding of skeletal fragility in glomerular disease is lacking. In the first large population-based cohort study, we recently found that primary glomerular disease was independently associated with an increased risk of incident fracture, and that hip fracture risk was >2-fold greater in patients younger vs. older than 40 years of age. Mechanisms that drive increased fracture risk in glomerular disease are not clear but likely multifactorial. Our prior work demonstrated that glomerular disease is associated with disturbances in vitamin D and mineral metabolism, in addition to and exacerbated by reduced kidney function.
Patients with glomerular disease are also exposed to medications which may negatively impact bone health, most notably high-dose and long-term glucocorticoid therapy. Identifying modifiable factors that compromise bone strength will facilitate the development of strategies to reduce fractures and other skeletal complications across the life course. The proposed multi-center study will leverage the infrastructure of the NIH-funded Cure Glomerulopathy (CureGN) prospective cohort study and the resources of two health systems with expertise in state-of-the-art high-resolution bone imaging methods, to conduct the first prospective, longitudinal study to assess determinants of impaired bone quality and strength in glomerular disease.
- Conditions
- Glomerular Disease, Bone Diseases, Metabolic, Bone Fracture
- Being tested
- Dual-energy X-ray absorptiometry, High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), Blood draw and Urine collection, Questionnaires
- Keywords
- Kidney Disease, Bone Fracture
- Medical subject headings
- Bone Diseases, Metabolic, Fractures, Bone, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy X-ray absorptiometryRadiation
Also called Bone density
DXA whole body, hip, spine, and radius at baseline, and 12-month visit.
High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)Radiation
Also called HR-pQCT
HR-pQCT of the radius and tibia at baseline, and 12-month visit.
Blood draw and Urine collectionOther
The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.
QuestionnairesOther
Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.
| Study group | Role | What they receive |
|---|---|---|
| BoneGN participants | Participants who have already been recruited into the CureGN study, or meet its criteria. Receives: Radiation: Dual-energy X-ray absorptiometry; Radiation: High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT); Other: Blood draw and Urine collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radius bone strength (failure load)
HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.
Measured: Baseline and 12 months
Change in tibia bone strength (failure load)
HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.
Measured: Baseline and 12 months
Secondary outcomes (12)
Radius mid-shaft failure load
Measured with HR-pQCT
Measured: Up to 12 months
Tibia mid-shaft failure load
Measured with HR-pQCT
Measured: Up to 12 months
Cortical density of radius
Measured with HR-pQCT
Measured: Up to 12 months
Cortical density of tibia
Measured with HR-pQCT
Measured: Up to 12 months
Cortical thickness of radius
Measured with HR-pQCT
Measured: Up to 12 months
Cortical thickness of tibia
Measured with HR-pQCT
Measured: Up to 12 months
Areal bone mineral density (aBMD) at the hip
Hip (total and femoral neck) is measured with dual-energy x-ray absorptiometry (DXA)
Measured: Up to 12 months
aBMD at forearm
Forearm (one-third and ultradistal radius) is measured with DXA
Measured: Up to 12 months
aBMD at lumbar spine
Lumbar spine is measured with DXA
Measured: Up to 12 months
Bone mineral content at the hip
Hip (total and femoral neck) is measured with dual-energy x-ray absorptiometry (DXA)
Measured: Up to 12 months
Bone mineral content at forearm
Forearm (one-third and ultradistal radius) is measured with DXA
Measured: Up to 12 months
Bone mineral content at lumbar spine
Lumbar spine is measured with DXA
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start14 Jun 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nickolas, MD MS, Columbia University
- Investigators
- Thomas L. Nickolas, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528446
- Sponsor's protocol ID
- AAAS0922
- Other IDs
- R01DK119266
- Acronym
- BoneGN
- Status last verified
- Jun 2024
- First submitted
- 24 Aug 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only investigators and study team members that have completed appropriate institutional review board (IRB) training/approval are eligible to collect and work on information collected from this study.
Publications
Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
PubMed 27887750Floege J, Amann K. Primary glomerulonephritides. Lancet. 2016 May 14;387(10032):2036-48. doi: 10.1016/S0140-6736(16)00272-5. Epub 2016 Feb 25.
PubMed 26921911Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
PubMed 28236831Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18.
PubMed 26684326Denburg MR, Kumar J, Jemielita T, Brooks ER, Skversky A, Portale AA, Salusky IB, Warady BA, Furth SL, Leonard MB. Fracture Burden and Risk Factors in Childhood CKD: Results from the CKiD Cohort Study. J Am Soc Nephrol. 2016 Feb;27(2):543-50. doi: 10.1681/ASN.2015020152. Epub 2015 Jul 2.
PubMed 26139439Phan V, Blydt-Hansen T, Feber J, Alos N, Arora S, Atkinson S, Bell L, Clarson C, Couch R, Cummings EA, Filler G, Grant RM, Grimmer J, Hebert D, Lentle B, Ma J, Matzinger M, Midgley J, Pinsk M, Rodd C, Shenouda N, Stein R, Stephure D, Taback S, Williams K, Rauch F, Siminoski K, Ward LM; Canadian STOPP Consortium. Skeletal findings in the first 12 months following initiation of glucocorticoid therapy for pediatric nephrotic syndrome. Osteoporos Int. 2014 Feb;25(2):627-37. doi: 10.1007/s00198-013-2466-7. Epub 2013 Aug 16.
PubMed 23948876Alem AM, Sherrard DJ, Gillen DL, Weiss NS, Beresford SA, Heckbert SR, Wong C, Stehman-Breen C. Increased risk of hip fracture among patients with end-stage renal disease. Kidney Int. 2000 Jul;58(1):396-9. doi: 10.1046/j.1523-1755.2000.00178.x.
PubMed 10886587
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Glomerular Disorders on Bone Quality and Strength
- ClinicalTrials.gov ID
- NCT04528446
- Acronym / sponsor ID
- BoneGN / AAAS0922
- Conditions
- Glomerular Disease, Bone Diseases, Metabolic, Bone Fracture
- Keywords
- Kidney Disease, Bone Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to: (1) determine the impact of glomerular disease on bone strength and (2) investigate the pathophysiologic underpinnings of impaired bone strength in glomerular disease.
Detailed description
Children and adults with glomerular disease have unique and potentially modifiable risk factors for compromised bone health, but our current understanding of skeletal fragility in glomerular disease is lacking. In the first large population-based cohort study, we recently found that primary glomerular disease was independently associated with an increased risk of incident fracture, and that hip fracture risk was >2-fold greater in patients younger vs. older than 40 years of age. Mechanisms that drive increased fracture risk in glomerular disease are not clear but likely multifactorial. Our prior work demonstrated that glomerular disease is associated with disturbances in vitamin D and mineral metabolism, in addition to and exacerbated by reduced kidney function.
Patients with glomerular disease are also exposed to medications which may negatively impact bone health, most notably high-dose and long-term glucocorticoid therapy. Identifying modifiable factors that compromise bone strength will facilitate the development of strategies to reduce fractures and other skeletal complications across the life course. The proposed multi-center study will leverage the infrastructure of the NIH-funded Cure Glomerulopathy (CureGN) prospective cohort study and the resources of two health systems with expertise in state-of-the-art high-resolution bone imaging methods, to conduct the first prospective, longitudinal study to assess determinants of impaired bone quality and strength in glomerular disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BoneGN participants | – | Radiation: Dual-energy X-ray absorptiometry, Radiation: High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), Other: Blood draw and Urine collection, Other: QuestionnairesParticipants who have already been recruited into the CureGN study, or meet its criteria. |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Prospective cohort study of 150 CureGN participants (100 adults/50 children) will be evaluated at baseline and 12 months. The CureGN DCC at Arbor Research will identify CureGN participants eligible for inclusion. Recruitment of healthy participants will also occur by leveraging the services of the CHOP Recruitment Enhancement Core (REC), Pediatric Research Consortium (PeRC) and the RecruitMe tool provided by the Clinical Trials Office at CUMC. Healthy adult controls will be recruited from patients who receive outpatient care within the Penn Primary Care Networks, Penn employees and students, an extensive database of individuals who have participated in prior research studies at Penn and through local advertising on the Penn campus.
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Chronic Dialysis
- Solid organ transplantation
- Lower extremity amputations or non-ambulatory
- Malignancy requiring chemotherapy or metastatic to bone
- Metabolic bone disease (e.g., Paget's disease, primary hyperparathyroidism)
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: Bone densityDXA whole body, hip, spine, and radius at baseline, and 12-month visit. | Radiation | BoneGN participants |
| High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)Also: HR-pQCTHR-pQCT of the radius and tibia at baseline, and 12-month visit. | Radiation | BoneGN participants |
| Blood draw and Urine collectionThe blood draw can be completed +/- 3 weeks from baseline or 12-month visit. | Other | BoneGN participants |
| QuestionnairesQuestionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit. | Other | BoneGN participants |
Primary outcome
Change in radius bone strength (failure load)
Time frame: Baseline and 12 months
HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.
Change in tibia bone strength (failure load)
Time frame: Baseline and 12 months
HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.
12 secondary outcomes
Radius mid-shaft failure load
Time frame: Up to 12 months
Tibia mid-shaft failure load
Time frame: Up to 12 months
Cortical density of radius
Time frame: Up to 12 months
Cortical density of tibia
Time frame: Up to 12 months
Cortical thickness of radius
Time frame: Up to 12 months
Cortical thickness of tibia
Time frame: Up to 12 months
Areal bone mineral density (aBMD) at the hip
Time frame: Up to 12 months
aBMD at forearm
Time frame: Up to 12 months
aBMD at lumbar spine
Time frame: Up to 12 months
Bone mineral content at the hip
Time frame: Up to 12 months
Bone mineral content at forearm
Time frame: Up to 12 months
Bone mineral content at lumbar spine
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 27887750Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
- Background: PubMed 26921911Floege J, Amann K. Primary glomerulonephritides. Lancet. 2016 May 14;387(10032):2036-48. doi: 10.1016/S0140-6736(16)00272-5. Epub 2016 Feb 25.
- Background: PubMed 28236831Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
- Background: PubMed 26684326Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18.
- Background: PubMed 26139439Denburg MR, Kumar J, Jemielita T, Brooks ER, Skversky A, Portale AA, Salusky IB, Warady BA, Furth SL, Leonard MB. Fracture Burden and Risk Factors in Childhood CKD: Results from the CKiD Cohort Study. J Am Soc Nephrol. 2016 Feb;27(2):543-50. doi: 10.1681/ASN.2015020152. Epub 2015 Jul 2.
- Background: PubMed 23948876Phan V, Blydt-Hansen T, Feber J, Alos N, Arora S, Atkinson S, Bell L, Clarson C, Couch R, Cummings EA, Filler G, Grant RM, Grimmer J, Hebert D, Lentle B, Ma J, Matzinger M, Midgley J, Pinsk M, Rodd C, Shenouda N, Stein R, Stephure D, Taback S, Williams K, Rauch F, Siminoski K, Ward LM; Canadian STOPP Consortium. Skeletal findings in the first 12 months following initiation of glucocorticoid therapy for pediatric nephrotic syndrome. Osteoporos Int. 2014 Feb;25(2):627-37. doi: 10.1007/s00198-013-2466-7. Epub 2013 Aug 16.
- Background: PubMed 10886587Alem AM, Sherrard DJ, Gillen DL, Weiss NS, Beresford SA, Heckbert SR, Wong C, Stehman-Breen C. Increased risk of hip fracture among patients with end-stage renal disease. Kidney Int. 2000 Jul;58(1):396-9. doi: 10.1046/j.1523-1755.2000.00178.x.
- Individual participant dataSharing planned: No. Only investigators and study team members that have completed appropriate institutional review board (IRB) training/approval are eligible to collect and work on information collected from this study.
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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.
Thomas L. Nickolas, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerular Disease and Bone Diseases, Metabolic, run by Columbia University at 2 sites in United States.
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 0 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria A. Aponte ((212) 342-4678, maa2308@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radius bone strength (failure load) (time frame: Baseline and 12 months). The study lists 2 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 NCT04528446, which also lists 7 linked publications.
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 1 Jul 2024.