Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients
Condition: Skeletal Anomalies; Kidney Transplant; Complications
MeSH terms: Bone Diseases; Bone Diseases, Metabolic
Study type: Interventional

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.
    

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.

      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.
    

Intervention name(s): measurements to evaluate metabolic bone disease; standard care
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening