NCT04528446

The Impact of Glomerular Disorders on Bone Quality and Strength

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 5 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
RADIATION	Dual-energy X-ray absorptiometry	DXA whole body, hip, spine, and radius at baseline, and 12-month visit.
RADIATION	High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)	HR-pQCT of the radius and tibia at baseline, and 12-month visit.
OTHER	Blood draw and Urine collection	The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.
OTHER	Questionnaires	Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.

Timeline

• Start date: 2019-06-14
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-08-27
• Last updated: 2024-07-01

Locations

2 sites across 1 country: United States