| Trial ID: | L1589 |
| Source ID: | NCT03960554
|
| Associated Drug: |
Denosumab Inj 60 Mg/Ml
|
| Title: |
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
|
| Acronym: |
ProliaKTx
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03960554/results
|
| Conditions: |
Osteoporosis|Renal Osteodystrophy|Kidney Transplant; Complications
|
| Interventions: |
DRUG: Denosumab Inj 60 mg/ml|OTHER: Placebo
|
| Outcome Measures: |
Primary: Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA), BMD will be measured to determine if 1-year of treatment with denosumab changes BMD as measured by DXA., 12 months|Estimated Bone Strength Measured by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Imaging, Estimated bone mechanical competence will be measured by HR-pQCT., 12 months |
|
| Sponsor/Collaborators: |
Sponsor: Thomas Nickolas, MD MS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
8
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-16
|
| Completion Date: |
2021-12-02
|
| Results First Posted: |
2024-07-25
|
| Last Update Posted: |
2024-07-25
|
| Locations: |
Northwestern University, Feinburg School of Medicine, Chicago, Illinois, 60611, United States|NorthShore University HealthSystem, Evanston, Illinois, 60201, United States|Columbia University Medical Center, New York, New York, 10032, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03960554
|
