Status:
COMPLETED
Osteopenia and Renal Osteodystrophy: Evaluation and Management
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Osteopenia
Renal Osteodystrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 complication...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108394
Start Date
October 1 2002
End Date
September 1 2007
Last Update
January 21 2009
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108