drugset / Trial / NCT01535027

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

NCT01535027

Phase 4 Completed 125 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelTreatment

Summary

Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.

Timeline

Start
2006-03
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 70 mg Oral
Comparator Raloxifene Other / unclassified 60 mg Oral
Comparator Teriparatide Protein / enzyme biologic 20 ug Subcutaneous

Indications