Osteopenia and Renal Osteodystrophy: Evaluation and Management

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Pamidronate

Criteria

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