Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108394
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-04-14
Brief Title:
Osteopenia and Renal Osteodystrophy Evaluation and Management
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Osteopenia and Renal Osteodystrophy Evaluation and Management
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate whether pamidronate will preserve or increase bone mass in patients with adynamic bone disease caused by low bone turnover
Detailed Description:
Detailed Summary Bone disease has been a well-recognized complication of renal disease for over 100 years Until the advent of dialysis however it was only another of the many dreadful complications of a fatal disease Almost since the onset of dialysis however bone disease and calcium metabolism presented major difficulties to patients and physicians Recently we reported that dialysis patients had an 8-fold increase in hip fracture rate compared to the normal population In younger dialysis patients age 30-50 years this risk was increased to nearly 100 fold We have also noted a similar or even higher incidence of fracture in the transplant population Low bone mass has been found in dialysis patients by ourselves and other investigators a finding in the general population which predisposes to fracture In the dialysis population bone histologic studies done by us and others have reported the adynamic low turnover lesion in more than half of the dialysis population This lesion is similar to what is seen in osteoporosis Thus dialysis patients like osteoporotics have low bone mass low bone turnover and a high fracture rate In the osteoporotic patients various bisphosphonates have been shown to inhibit bone resorption increase bone mass and decrease fracture rate The only bisphosphonate approved for use in patients with renal failure is pamidronate This agent has not been used extensively in the general population because it must be given intravenously This together with the fact that pamidronate has a bone half-life of over 300 days actually makes this drug a strong candidate for the treatment of patients with renal failure In this investigation we propose using pamidronate in patients with renal failure to prevent bone loss and fracture We will monitor bone mass by DEXA in patients to assess treatment response assess bone histology in selected subjects and collect data on fractures in the population
Comparison Subjects with normal or low parathyroid hormone PTH who receive dosing with pamidronate will be compared to similar subjects who receive placebo Comparison groups will be randomly assigned and assignment will be blind
Comparison Subjects with normal or low parathyroid hormone PTH who receive dosing with pamidronate will be compared to similar subjects who receive placebo Comparison groups will be randomly assigned and assignment will be blind
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None