Chronic Kidney Disease Clinical Trial
Official title:
Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease
Verified date | July 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Kidney disease patients have a variety of bone disorders that result in bone loss and fractures. The mechanisms of these bone disorders are not clear but may be related to abnormal modification of a bone protein known as collagen. Therefore, the investigators are conducting this research study to identify underlying mechanisms that are responsible for the disruption of bone collagen and determining whether the abnormal bone collagen impairs bone strength. The investigators intend to identify these mechanisms through studying relationships between kidney disease and bone strength via bone imaging, bone biopsy and non-invasive measures from blood and skin.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Chronic kidney disease stage 3, 4 or 5 - Stable dose of vitamin D for 2-months Exclusion Criteria: - Dialysis - Current use or treatment in the past one year with oral or inhaled glucocorticoids for more than 90 days. - Current use or treatment in the past one year with sex hormone/SERM therapy for more than 30 days. - Any use of bisphosphonates. - Use of anti-osteoporosis therapies (denosumab, teriparatide, calcitonin or anti-sclerostin antibodies) in last 2 years. - Any solid organ transplant or bone marrow transplant (Not including skin or cornea). - Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy. - Any cancers within 5-yrs of diagnosis that were metastatic to bone, and that are not in complete remission - Any history of leukemia, multiple myeloma, lymphoma, amyloid or paraproteinemias. - Any congenital or acquired collagen of bone diseases other than osteoporosis or renal osteodystrophy (Including but not limited to: Osteogenesis Imperfecta, X-Linked Hypophosphatemic Rickets, Pagets or Cushings Disease). - History of Primary Hyperparathyroidism within 2-years of Parathyroidectomy. - Hypoparathyroidism - primary or post-surgical - Hyperthyroidism - if untreated and not on stable dose of medication for 6 months - Hypothyroidism - if untreated and not on stable dose of medication for 6 months - Non-ambulatory - Bilateral lower extremity amputations. - Weight >300 lbs. - Medical disease - end stage heart, end stage liver, celiac disease and other intestinal malabsorption |
Country | Name | City | State |
---|---|---|---|
United States | Columbia/CUMC | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine amounts of abnormal collagen present in the bone of CKD patients | In patients with CKD stage 3-5, the investigators will obtain transiliac crest bone biopsies and determine the amount of advanced glycation end-products that are present in bone collagen | 2.5 years | |
Primary | Determine if greater amounts of abnormal collagen in the bone of CKD patients decreases bone strength | In patients with CKD stage 3-5, the investigators will perform biomechanical testing of bone biopsy specimens and determine if greater degree of advanced glycation end-product modification of bone collagen changes bone strength. | 1 year | |
Primary | To identify non-invasive biomarkers of advanced glycation end-products in bone collagen | In patients with CKD stage 3-5, to obtain blood and skeletal imaging with high resolution peripheral computed tomography and to determine if the concentration of advanced glycation end-products in bone collagen can be identified by non-invasive methods. | 1 year |
Status | Clinical Trial | Phase | |
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