drugset / Trial / NCT00500409

Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

NCT00500409

Phase 3 Completed 82 enrolled Virchow Group
RandomizedParallel-groupOpen-labelTreatment

Summary

OSTEOFORM, containing recombinant (rhPTH \[1-34\]), enhances bone mineral density and reduces risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the treatment of osteoporosis in post-menopausal women.

Timeline

Start
2005-12
Primary completion
2006-12
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic 20 ug Subcutaneous
Comparator Calcium carbonate Other / unclassified 1000 mg Oral
Comparator Vitamin D Other / unclassified 500 iu Oral

Indications