Investigating how kidney disorders affect bone health
The Impact of Glomerular Disorders on Bone Quality and Strength
This study is trying to see how kidney problems affect bone health in children and adults to find ways to prevent fractures and improve bone strength.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 5 Years to 55 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04528446 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the impact of glomerular disease on bone strength and the underlying mechanisms that contribute to impaired bone health. It will involve children and adults diagnosed with glomerular disease, utilizing advanced imaging techniques and biological assessments to evaluate bone quality. The study seeks to identify modifiable risk factors that could lead to strategies for reducing fractures and other skeletal complications in these patients. By leveraging existing cohort data and health system resources, this research represents a significant step in addressing the skeletal fragility associated with kidney disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 5 to 55 years with a diagnosis of glomerular disease who meet specific eligibility criteria.
Not a fit: Patients on chronic dialysis, those who have undergone solid organ transplantation, or individuals with certain malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing fractures and enhancing bone health in patients with glomerular disease.
How similar studies have performed: While this study is among the first to prospectively assess bone quality in glomerular disease, previous studies have indicated a significant association between kidney disorders and increased fracture risk, suggesting a foundation for potential success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for participants with glomerular disease: 1. 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: 1. First diagnostic kidney biopsy within 5 years of CureGN study enrollment 2. Access to first kidney biopsy report and/or slides or not being interested in study participation. 2. Males or females 5 to 55 years (premenopausal for women) 3. Females must have a negative urine/serum pregnancy test 4. 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) 5. Consent/Parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria for all participants 1. Chronic Dialysis 2. Solid organ transplantation 3. Lower extremity amputations or non-ambulatory 4. Malignancy requiring chemotherapy or metastatic to bone 5. Metabolic bone disease (e.g., Paget's disease, primary hyperparathyroidism) 6. Endocrinopathy (current hyperthyroidism or untreated hypothyroidism, Cushing's syndrome) 7. Medical diseases (end stage liver disease, heart or lung disease, intestinal malabsorption) 8. Those treated with bisphosphonates, teriparatide, calcitonin, selective estrogen receptor modulators, estrogen, or phenytoin in the past 12 months 9. Previous bilateral wrist and tibia fractures 10. Pregnant or lactating females 11. Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Where this trial is running
New York, New York and 1 other locations
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Thomas L. Nickolas, MD — Columbia University
- Study coordinator: Maria A. Aponte
- Email: maa2308@cumc.columbia.edu
- Phone: (212) 342-4678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.