CompletedPhase 4

Osteopenia and Renal Osteodystrophy: Evaluation and Management

United StatesStarted 2002-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Trial details

NCT IDNCT00108394

SponsorUS Department of Veterans Affairs

Sponsor typeFED

Study typeINTERVENTIONAL

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