Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03960554
Status:
TERMINATED
Last Update Posted:
2022-04-15
First Post:
2019-05-21
Brief Title:
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
Sponsor:
Thomas Nickolas MD MS
Organization:
Columbia University
Study Overview
Official Title:
The Effects of 12-months of Denosumab on Bone Density Quality and Strength in Prevalent Kidney Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study lost funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProliaKTx
Brief Summary:
This is a Phase 2 Multi-Center Clinical Trial safety and effectiveness trial in 60 patients 40 denosumab 20 placebo who have had a kidney transplant for 12-months or longer with more than 30 of kidney function The investigators will test whether denosumab safely improves bone mineral density BMD by dual-energy X-ray absorptiometry DXA and improves bone strength by high resolution peripheral quantitative computed tomography HR-pQCT in the subset of patients recruited at Columbia University Irving Medical Center These data will inform the development and execution of a larger trial to test if denosumab prevents fractures in kidney transplant recipients
Detailed Description:
Bone fractures are 3-times more common in kidney transplant recipients than in the general population and risk of dying after a hip fracture is 60 higher compared to kidney transplant recipients without a fracture Unfortunately there are no anti-fracture strategies that have been proven to be effective in double blinded randomized clinical trials for kidney transplant recipients This is because some anti-fracture medications that are commonly used to treat osteoporosis and prevent fractures in the general population ie bisphosphonates may be harmful to the skeleton when kidney function is less than 30 of normal In addition intravenous bisphosphonates may be toxic to the kidneys which further limits their utility in patients with a kidney transplant
Denosumab a monoclonal antibody against RANKL inhibits osteoclast function and is not harmful to the kidney Denosumab prevents fractures in men and women with age-related and glucocorticoid-induced osteoporosis Recently a non-blinded randomized trial of denosumab versus usual care during the first year of kidney transplantation in 90 patients reported the bone mineral density BMD measured by dual energy X-ray absorptiometry DXA increased at the spine and hip and that bone strength measured by high resolution peripheral quantitative computed tomography HR-pQCT increased in patients treated with denosumab Adverse events in denosumab-treated patients included greater risk of urinary tract infections diarrhea and transient levels of low serum calcium that were asymptomatic This study demonstrated that denosumab safely increased BMD at the spine and hip in new kidney transplant recipients However long-term kidney recipients who comprise the vast majority of patients living with a transplanted kidney and who are also at increased risk of fracture were not included
Denosumab a monoclonal antibody against RANKL inhibits osteoclast function and is not harmful to the kidney Denosumab prevents fractures in men and women with age-related and glucocorticoid-induced osteoporosis Recently a non-blinded randomized trial of denosumab versus usual care during the first year of kidney transplantation in 90 patients reported the bone mineral density BMD measured by dual energy X-ray absorptiometry DXA increased at the spine and hip and that bone strength measured by high resolution peripheral quantitative computed tomography HR-pQCT increased in patients treated with denosumab Adverse events in denosumab-treated patients included greater risk of urinary tract infections diarrhea and transient levels of low serum calcium that were asymptomatic This study demonstrated that denosumab safely increased BMD at the spine and hip in new kidney transplant recipients However long-term kidney recipients who comprise the vast majority of patients living with a transplanted kidney and who are also at increased risk of fracture were not included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None