Osteopenia Clinical Trial
Official title:
Osteopenia and Renal Osteodystrophy: Evaluation and Management
Verified date | March 2008 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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