- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108394
Osteopenia and Renal Osteodystrophy: Evaluation and Management
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Calcium Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Hyperparathyroidism, Secondary
- Hyperparathyroidism
- Bone Diseases, Metabolic
- Chronic Kidney Disease-Mineral and Bone Disorder
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Pamidronate
Other Study ID Numbers
- CLIN-017-02S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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