Osteopenia Clinical Trial
Official title:
Osteopenia and Renal Osteodystrophy: Evaluation and Management
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 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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