NCT00108394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 21, 2009

Status Verified

March 1, 2008

First QC Date

April 14, 2005

Last Update Submit

January 20, 2009

Conditions

OsteopeniaRenal Osteodystrophy

Keywords

UremiaDialysisClinical TrialsBone Diseases, Metabolicadynamic bone diseaselow bone turnover

Interventions

pamidronateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicChronic Kidney Disease-Mineral and Bone DisorderUremia

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRicketsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

October 1, 2002

Study Completion

September 1, 2007

Last Updated

January 21, 2009

Record last verified: 2008-03

Locations

US(1)