Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients

Yale University

Status: Completed

Conditions: Kidney Transplant; Complications; Skeletal Anomalies

Treatments: Diagnostic Test: standard care; Diagnostic Test: measurements to evaluate metabolic bone disease

Study type: Interventional

Funder types: Other

Identifiers

NCT03958409

2000022066

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Rigorous evaluation

Experimental group

Description:

Participants will be evaluated for the rigorous evaluation received.

Treatment:

Diagnostic Test: measurements to evaluate metabolic bone disease

Standard care

Active Comparator group

Description:

The participants will be evaluated for the standard of care received.

Treatment:

Diagnostic Test: standard care