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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 : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
There is a well-documented increased risk for disordered mineral bone homeostasis in Kidney Transplant Recipients (KTRs) when compared to the general population, leading to a markedly increased risk for fragility fractures and their associated morbidity and mortality. A more uniform and rigorous evaluation of bone and mineral homeostasis,than is afforded to patients under "normal care", will result in better clinical outcomes in KTRs.

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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, 2020
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients receiving rigorous evaluation
The participants will be evaluated for 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.
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, we will measure bone mass at the lumbar spine, wrist, hip and total body bone mass at 3, and 18 months.

Active Comparator: Patients receiving standard care
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. We cannot use a coincident Control Cohort because knowledge of the additional data to be collected in the Control Cohort will undoubtedly influence their care by their attending nephrologists and surgeons.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kidney transplant subjects within the first 3 months after surgery (intervention cohort) and 18 months after surgery (control cohort)
  • Age between 30 to 65 years old
  • Estimated glomerular filtration rate (GFR) > 35 ml/min/1.73 m2

Exclusion Criteria:

  • Major acute post-operatory complications (infection, urine leak, delayed graft function)
  • Living related-donor KTRs
  • Estimated GFR ≤ 35 ml/min/1.73 m2
  • Significant skin disorder, bruising, local edema, skin infection or are being treated with anticoagulants (such as warfarin, heparin, low molecular weight heparin or direct thrombin inhibitors) or have known or acquired clotting disorders since the OsteoProbe® procedure would be unsafe
  • Patients who do not plan to be followed at Yale New Haven for at least 18 months
  • Morbidly obese (BMI >40)
  • History of gastroparesis

Information from the National Library of Medicine

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


Contacts
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Contact: Renata Belfort De Aguiar, PhD,MD 203-785-7474 renata.aguiar@yale.edu

Locations
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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    renata.aguiar@yale.edu   
Contact: Elizabeth Sanchez-Rangel, MD         
Principal Investigator: Renata De Aguiar Belfort, PhD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Renata Belfort de Aguiar, Phd,MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03958409     History of Changes
Other Study ID Numbers: 2000022066
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases