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Osteopenia and Renal Osteodystrophy: Evaluation and Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00108394
Recruitment Status : Completed
First Posted : April 15, 2005
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Osteopenia Renal Osteodystrophy Drug: pamidronate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Osteopenia and Renal Osteodystrophy: Evaluation and Management
Study Start Date : October 2002
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00108394

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United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
US Department of Veterans Affairs

Layout table for additonal information Identifier: NCT00108394    
Other Study ID Numbers: CLIN-017-02S
First Posted: April 15, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: March 2008
Keywords provided by VA Office of Research and Development:
Clinical Trials
Bone Diseases, Metabolic
adynamic bone disease
low bone turnover
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Chronic Kidney Disease-Mineral and Bone Disorder
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases