Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Summary

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Timeline

Start

2006-06

Primary completion

2009-06

Completion

2010-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Teriparatide vs Risedronate; p = 0.642; Chi-square; note: All comparisons were conducted using a 2-sided significance level of 0.05. NCT00343252 ↗

release “on back pain in postmenopausal women with osteoporotic vertebral fractures. The study showed no difference between FORTEO and risedronate on the primary endpoint” lilly.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Risedronate	Small molecule	35 mg	Oral
Subject	Teriparatide	Protein / enzyme biologic	20 ug	Subcutaneous

Indications