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NCT03958409 · ClinicalTrials.gov registry record · NA
Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients
A NA study of Kidney Transplant; Complications and Skeletal Anomalies, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03958409: Completed NA study of Kidney Transplant; Complications and Skeletal Anomalies, sponsored by Yale University.
NCT03958409 is a NA study of Kidney Transplant; Complications and Skeletal Anomalies that has completed, run by Yale University. The registered enrollment target is 8 participants, below the 121-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03958409, a NA study of Kidney Transplant; Complications and Skeletal Anomalies, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST measurements to evaluate metabolic bone disease
- DIAGNOSTIC_TEST standard care
Study Locations (1)
Connecticut
- Yale Transplantation Center/Yale-New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2021-12-02 |
| Phase | NA |
What the finished NCT03958409 record still lists
NCT03958409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 121-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Kidney Transplant; Complications appearing as the primary indexed condition, and to 2 interventions - of which measurements to evaluate metabolic bone disease is the first listed.
NCT03958409 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03958409 about?
NCT03958409 is a clinical study titled "Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients". 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 eva...
What is the current status of trial NCT03958409?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2018-12-12. Estimated completion is 2021-12-02.
What conditions does trial NCT03958409 study?
This clinical trial studies the following conditions: Kidney Transplant; Complications, Skeletal Anomalies.
What interventions are being tested in trial NCT03958409?
The interventions under investigation include: measurements to evaluate metabolic bone disease (DIAGNOSTIC_TEST), standard care (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03958409?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03958409 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant; Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03958409's enrollment target sits among peer trials
8 20th of 19 the lowest of 19 other Kidney Transplant; Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant; Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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