The Impact of Glomerular Disorders on Bone Quality and Strength

NCT04528446 | Recruiting DMC

• 2 other identifiers: AAAS0922R01DK119266
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glomerular Disease; Bone Diseases, Metabolic; Bone Fracture

Keywords

Kidney Disease; Bone Fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 12 months

Secondary Outcomes (12)

• Radius mid-shaft failure load

  Up to 12 months

• Tibia mid-shaft failure load

  Up to 12 months

• Cortical density of radius

  Up to 12 months

• Cortical density of tibia

  Up to 12 months

• Cortical thickness of radius

  Up to 12 months

Study Arms (1)

BoneGN participants

Participants who have already been recruited into the CureGN study, or meet its criteria.

Radiation: Dual-energy X-ray absorptiometry; Radiation: High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT); Other: Blood draw and Urine collection; Other: Questionnaires

Interventions

Dual-energy X-ray absorptiometry RADIATION

DXA whole body, hip, spine, and radius at baseline, and 12-month visit.

Also known as: Bone density

BoneGN participants

High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) RADIATION

HR-pQCT of the radius and tibia at baseline, and 12-month visit.

Also known as: HR-pQCT

BoneGN participants

Blood draw and Urine collection OTHER

The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.

BoneGN participants

Questionnaires OTHER

Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.

BoneGN participants

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• CureGN participant or CureGN Eligible
• CureGN eligible is defined as having a diagnosis of Glomerulonephropathy (GN). Patients would otherwise be enrolled in be in CureGN study, except for lacking a minor entry criteria, such as:
• First diagnostic kidney biopsy within 5 years of CureGN study enrollment
• Access to first kidney biopsy report and/or slides or not being interested in study participation.
• Males or females 5 to 55 years (premenopausal for women)
• Females must have a negative urine/serum pregnancy test
• Stable doses of nutritional vitamin D or active vitamin D therapy for at least 3 months before enrollment ((if on either form of Vitamin D)
• Consent/Parental/guardian permission (informed consent) and if appropriate, child assent

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 27887750 BACKGROUND

• Floege 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.

  PMID: 26921911 BACKGROUND

• Saran 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.

  PMID: 28236831 BACKGROUND

• Clark 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.

  PMID: 26684326 BACKGROUND

• Denburg 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.

  PMID: 26139439 BACKGROUND

• Phan 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.

  PMID: 23948876 BACKGROUND

• Alem 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.

  PMID: 10886587 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood specimens (up to 50 ml or 3 ml/kg whichever is less) will be collected by venipuncture by a trained phlebotomist, and aliquots of serum and plasma will be stored at each visit for assays anticipated to be performed in one or two batches at the end of the study and biobanking for future studies. * Participants will be asked to provide 20 ml urine sample for biobanking at the time of the baseline and 12 month follow-up visits.

MeSH Terms

Conditions

Bone Diseases, Metabolic; Fractures, Bone; Kidney Diseases

Interventions

Absorptiometry, Photon; Bone Density; Blood Specimen Collection; Urine Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Thomas L. Nickolas, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A. Aponte

CONTACT

(212) 342-4678; maa2308@cumc.columbia.edu

Thomas L. Nickolas, MD

CONTACT

(212) 305-3273; tln2001@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: June 14, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)