An observational study in Glomerular Disease, Bone Diseases, Metabolic and Bone Fracture, sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 5 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Columbia University · Observational
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.
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.
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.
Inclusion Criteria for participants with glomerular disease:
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:
Exclusion Criteria for all 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
DXA whole body, hip, spine, and radius at baseline, and 12-month visit.
Also known as: Bone density
HR-pQCT of the radius and tibia at baseline, and 12-month visit.
Also known as: HR-pQCT
The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.
Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.
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.
Time frame: 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.
Time frame: Baseline and 12 months
Radius mid-shaft failure load
Measured with HR-pQCT
Time frame: Up to 12 months
Tibia mid-shaft failure load
Measured with HR-pQCT
Time frame: Up to 12 months
Cortical density of radius
Measured with HR-pQCT
Time frame: Up to 12 months
Cortical density of tibia
Measured with HR-pQCT
Time frame: Up to 12 months
Cortical thickness of radius
Measured with HR-pQCT
Time frame: Up to 12 months
Cortical thickness of tibia
Measured with HR-pQCT
Time frame: 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)
Time frame: Up to 12 months
aBMD at forearm
Forearm (one-third and ultradistal radius) is measured with DXA
Time frame: Up to 12 months
aBMD at lumbar spine
Lumbar spine is measured with DXA
Time frame: Up to 12 months
Bone mineral content at the hip
Hip (total and femoral neck) is measured with dual-energy x-ray absorptiometry (DXA)
Time frame: Up to 12 months
Bone mineral content at forearm
Forearm (one-third and ultradistal radius) is measured with DXA
Time frame: Up to 12 months
Bone mineral content at lumbar spine
Lumbar spine is measured with DXA
Time frame: Up to 12 months
Plan to share: 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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