Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03626246|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease End Stage Kidney Disease Chronic Kidney Disease Mineral and Bone Disorder Renal Osteodystrophy Secondary Hyperparathyroidism||Other: Kidney disease|
Kidney disease patients have abnormal protein (bone collagen) modifications in their bone that may increase the risk of breaking a bone (fracture). Preventing bone collagen from becoming abnormal may decrease the risk of breaking a bone, such as the spine or hip. Currently, the effect of abnormal bone collagen on bone strength is not fully defined, and there are no methods to measure the abnormal protein content without a bone biopsy. The purpose of this study is to define the effects of bone collagen on bone strength and to identify non-invasive markers that will tell us how much abnormal collagen is in the bone. If the investigators are able to identify a non-invasive marker of abnormal bone protein then they may be able to prevent the build-up of this protein and lower the risk of a fracture.
If the participant chooses to be in the study, the investigators will get information from the participant's medical records such as diagnosis, the medicines and treatments prescribed by the participant's doctor, and the participant's lab test results.
There will be two study visits, each lasting about 3 hours.
Visit 1: At the baseline visit, study procedures include:
- Completing medical history, physical activity level, and dietary questionnaires for calcium and vitamin D.
- Blood sample
- Bone Imaging will: dual energy X-ray absorptiometry (DXA) to measure bone mineral density, high-resolution peripheral quantitative computed tomography (HRpQCT) to measure bone quality, and back x-rays to assess for the presence of spine fractures.Females who are able to become pregnant will also provide a urine specimen for pregnancy testing. (A negative pregnancy test is required prior to bone imaging.)
- Measure levels of Advanced Glycation End products (AGEs) in the skin of the participant's forearm and also in the participant's bone by bone biopsy. Advance Glycation End products may play a role in the development of weakened bone due to chronic kidney disease.
Visit 2: The participant's second visit will occur within 6-months of enrollment. At this visit, the participant will undergo a bone and muscle biopsy at the hip area under conscious sedation and a localized pain numbing medicine. The bone biopsy provides detailed information about the quality of the participant's bone that cannot be obtained through other tests like x-rays or blood tests. The investigators will use the bone biopsy to determine the amount of abnormal protein in the participant's bone. The muscle biopsy informs about the health of the participant's muscle fibers and allows us to detect any muscle mass wasting associated to chronic kidney disease. Since the piece of muscle is taken form the bone biopsy, no extra incision is needed.
The duration of the participant's participation from start of antibiotics through the actual bone biopsy will be approximately 3 weeks and 5 days (26 days).
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Patients who participate in our study are 40 years old or older and have a Chronic kidney disease stage 3, 4 or 5.
Other: Kidney disease
Being part of this study you agree to participate in all these interventions:
• Blood sample
• Bone and muscle biopsies.
- Determine amounts of abnormal collagen present in the bone of CKD patients [ Time Frame: 2.5 years ]In patients with CKD stage 3-5, the investogators will obtain transiliac crest bone biopsies and determine the amount of advanced glycation end-products that are present in bone collagen
- Determine if greater amounts of abnormal collagen in the bone of CKD patients decreases bone strength [ Time Frame: 1 year ]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.
- To identify non-invasive biomarkers of advanced glycation end-products in bone collagen [ Time Frame: 1 year ]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.
Biospecimen Retention: Samples With DNA
We would like to store the biological samples that you agreed to provide as part of this study: Blood, bone, urine and muscle.
DNA taken from these samples and/or the data obtained from the study and possibly use them for future research. They will be stored at CUMC either with the researchers on this study or in a central storage facility called a repository.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626246
|Contact: Thomas Nickolas, MD, MSfirstname.lastname@example.org|
|Contact: Maria Alejandra Aponteemail@example.com|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Principal Investigator 212-305-5020 firstname.lastname@example.org|
|Contact: Study Coordinator 212-342-4678 email@example.com|
|Principal Investigator:||Thomas Nickolas, MD,MS||Columbia University|