drugset / Trial / NCT00365456

Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

NCT00365456

Phase 3 Completed 407 enrolled Takeda
RandomizedSingle-groupOpen-labelTreatment

Summary

The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Timeline

Start
2006-07
Primary completion
2011-01
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous
Comparator Risedronate Small molecule 35 mg Oral

Indications