Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease
Completed
Conditions studied: Chronic Kidney Disease, End Stage Kidney Disease, Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy, Secondary Hyperparathyroidism
In brief
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.
Key facts
- Study ID
- NCT03626246
- Run by
- Columbia University
- People needed
- 50
- Starts
- 2016-07-01
- Expected to finish
- 2020-02-28
- Last updated by the study team
- 2021-07-13
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic kidney disease stage 3, 4 or 5
- Stable dose of vitamin D for 2-months
You may not qualify if…
- 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
Where it is running
- Columbia/CUMC — New York, New York, United States
Full record on ClinicalTrials.gov
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