Osteopenia and Renal Osteodystrophy: Evaluation and Management

Completed · Phase 4

Conditions studied: Osteopenia, Renal Osteodystrophy

In brief

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.

Key facts

Study ID

NCT00108394

Run by

US Department of Veterans Affairs

Starts

2002-10-01

Expected to finish

2007-09-01

Last updated by the study team

2009-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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