The Impact of Glomerular Disorders on Bone Quality and Strength
Columbia University
270 participants
Jun 14, 2019
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria11
- 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.
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Interventions
DXA whole body, hip, spine, and radius at baseline, and 12-month visit.
HR-pQCT of the radius and tibia at baseline, and 12-month visit.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04528446