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Osteopenia and Renal Osteodystrophy: Evaluation and Management

Primary Purpose

Osteopenia, Renal Osteodystrophy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pamidronate
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Uremia, Dialysis, Clinical Trials, Bone Diseases, Metabolic, adynamic bone disease, low bone turnover

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dialysis dependent for a minimum of 3 months Age greater than 18 years Low or normal bone turnover as defined by a mean intact PTH ≤400 pg/ml from a minimum of two values 6 months apart Informed consent Exclusion Criteria: Mean serum aluminum levels > 20 mcg/L during 1 year prior to consent Documented dementia Comorbidity such that survival for >3 years is unlikely Use of steroids within 3 months of consent Use of bisphosphonates in previous 2 years Use of sex hormones (testosterone or estrogen) within 3 months of consent Mean calcium < 9.0 mg/dL during the two months prior to consent Peritoneal dialysis patients Body weight < 45 kg

Sites / Locations

  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 14, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108394
Brief Title
Osteopenia and Renal Osteodystrophy: Evaluation and Management
Official Title
Osteopenia and Renal Osteodystrophy: Evaluation and Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Renal Osteodystrophy
Keywords
Uremia, Dialysis, Clinical Trials, Bone Diseases, Metabolic, adynamic bone disease, low bone turnover

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pamidronate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dialysis dependent for a minimum of 3 months Age greater than 18 years Low or normal bone turnover as defined by a mean intact PTH ≤400 pg/ml from a minimum of two values 6 months apart Informed consent Exclusion Criteria: Mean serum aluminum levels > 20 mcg/L during 1 year prior to consent Documented dementia Comorbidity such that survival for >3 years is unlikely Use of steroids within 3 months of consent Use of bisphosphonates in previous 2 years Use of sex hormones (testosterone or estrogen) within 3 months of consent Mean calcium < 9.0 mg/dL during the two months prior to consent Peritoneal dialysis patients Body weight < 45 kg
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Osteopenia and Renal Osteodystrophy: Evaluation and Management

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