The Impact of Glomerular Disorders on Bone Quality and Strength

Launched by COLUMBIA UNIVERSITY · Aug 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how glomerular disease, which affects the kidneys, impacts the strength and quality of bones. Researchers want to understand why people with glomerular disease often have weaker bones and are more prone to fractures. The trial is currently looking for participants aged 5 to 55 years, including both men and women, who have been diagnosed with glomerulonephropathy, a type of kidney disease. To be eligible, participants should not have certain medical conditions, such as being on chronic dialysis or having certain cancers.

If you or a family member is considering participating, you can expect to undergo assessments that will help the researchers gather important information about bone health. It is important that participants have stable vitamin D levels and are willing to provide consent. This study aims to shed light on the relationship between kidney health and bone strength, which could lead to better care for individuals facing these health challenges in the future.

Gender

ALL

Eligibility 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.