Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03958409|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skeletal Anomalies Kidney Transplant; Complications||Diagnostic Test: measurements to evaluate metabolic bone disease Diagnostic Test: standard care||Not Applicable|
The aim is to comprehensively characterize the mineral metabolism and skeletal phenotype in kidney transplant recipients (KTRs) to being to identify risk factors for post-kidney transplant mineral bone disease (PKT-MBD); and to evaluate whether treatment of abnormalities in these parameters will improve skeletal health as quantified by bone mineral density (BMD), bone turnover markers (rate of skeletal remodeling) and Osteoprobe (a direct index of bone quality using reference point indentation technology.
Participants in the rigorous evaluation arm will be followed with a) Mineral metabolism: blood calcium, phosphorus, parathyroid hormone (PTH), 25(OH) vitamin D; b) Bone turnover markers: bone-specific alkaline phosphatase, cross-linked C-telopeptide of type I collagen (CTx), and N-terminal propeptide of type I collagen (PINP); c)Bone Mineral Density using a Dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically.
NOTE: The use of the Osteoprobe was discontinued on 9/5/19 due to safety concerns from the FDA about the device in other trials/other sites.
The Control Cohort is essentially an historical control group who will have received standard of care for the 18 months ending just prior to the enrollment of our Intervention Cohort. A coincident Control Cohort will not be used because knowledge of the additional data to be collected in the Control Cohort will undoubtedly influence their care by their attending nephrologists and surgeons.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients|
|Actual Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Rigorous evaluation
Participants will be evaluated for the rigorous evaluation received.
Diagnostic Test: measurements to evaluate metabolic bone disease
The participants will be evaluated for a) Mineral metabolism: blood calcium, phosphorus, PTH, 25(OH) vitamin D; b) Bone turnover markers: bone-specific alkaline phosphatase, cross-linked C-telopeptide of type I collagen (CTx), and N-terminal propeptide of type I collagen (PINP); c) Bone Mineral Density using a Dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically. The bone mass at the lumbar spine, wrist, hip and total body bone mass at 3, and 18 months.
Active Comparator: Standard care
The participants will be evaluated for the standard of care received.
Diagnostic Test: standard care
Blood tests (Ca, Phos, PTH- mineral lab, 25OHVitD);Pregnancy Test (if applicable); dual energy X-ray absorptiometry (DXA); Bone Biopsy only if clinically indicated; treatment as clinically indicated.
- Change in bone turnover marker carboxy-terminal collagen crosslinks (CTx) [ Time Frame: 18 months ]In the intervention group changes in measures of mineral metabolism (serum calcium, phosphorus, PTH and 25 OH vitamin D levels), changes in bone turnover markers, BMD and bone quality markers will be compared to baseline results. The primary outcome variable will be the change in serum CTx from baseline. CTx is a marker of bone resorption and rates of resorption predict bone loss and fracture risk.
- Variance in bone loss [ Time Frame: 18 months ]the changes in PTH, CTx, Procollagen Type 1 N-Terminal Propeptide (P1NP), Trabecular Bone Score (TBS) and Bone Material Strength Index (BMSi) will be correlated with changes in bone mineral density (BMD) in a multiple regression model to determine their contributions to the variance in rates of bone loss. This will serve to inform our planned prospective study in terms of what measures to follow.
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): NCT03958409
|Contact: Renata Belfort De Aguiar, PhD,MDemail@example.com|
|United States, Connecticut|
|Yale Transplantation Center/Yale-New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Renata De Aguiar Belfort, PhD 203-785-7474 firstname.lastname@example.org|
|Contact: Elizabeth Sanchez-Rangel, MD|
|Principal Investigator: Renata De Aguiar Belfort, PhD|
|Principal Investigator:||Renata Belfort de Aguiar, Phd,MD||Yale University|