Status:
RECRUITING
The Impact of Glomerular Disorders on Bone Quality and Strength
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Glomerular Disease
Bone Diseases, Metabolic
Eligibility:
All Genders
5-55 years
Brief 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 glomeru...
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 i...
Eligibility Criteria
Inclusion
- 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:
- 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 Criteria for all participants
- 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.
Exclusion
Key Trial Info
Start Date :
June 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04528446
Start Date
June 14 2019
End Date
December 1 2024
Last Update
July 1 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104