drugset / Trial / NCT00666627

Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

NCT00666627

RandomizedParallel-groupOpen-labelTreatment

Summary

A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual-energy x-ray absorptiometry (DXA)? b) have different effects on bone cells and their activity as assessed by flow cytometry and biochemical markers of bone cell activity? The aim of the study is to compare the effects of three licensed bisphosphonates on bone quantity and quality. There has been no such study before. Most of the measures of bone quantity and quality used in this protocol have not been studied with any of these three agents. The novelty of the study necessitates the establishment of reference ranges and this explains the need for the inclusion of a group of young women.

Timeline

Start
2007-04
Primary completion
2012-09
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 70 mg
Comparator Ibandronate Other / unclassified
Comparator Risedronate Small molecule 35 mg