NCT03958409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

May 16, 2019

Last Update Submit

February 24, 2023

Conditions

Skeletal AnomaliesKidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • Change in bone turnover marker carboxy-terminal collagen crosslinks (CTx)

    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.

    18 months

Secondary Outcomes (1)

  • Variance in bone loss

    18 months

Study Arms (2)

Rigorous evaluation

EXPERIMENTAL

Participants will be evaluated for the rigorous evaluation received.

Diagnostic Test: measurements to evaluate metabolic bone disease

Standard care

ACTIVE COMPARATOR

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

Diagnostic Test: standard care

Interventions

measurements to evaluate metabolic bone diseaseDIAGNOSTIC_TEST

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.

Rigorous evaluation
standard careDIAGNOSTIC_TEST

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.

Standard care

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Transplantation Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Study Officials

  • Renata Belfort de Aguiar, Phd,MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 22, 2019

Study Start

December 12, 2018

Primary Completion

December 2, 2021

Study Completion

December 2, 2021

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

US(1)