NCT00343252

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

The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 712 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis, Postmenopausal
• Back Pain
• Spinal Fracture

Interventions

Type	Name	Description
DRUG	teriparatide	20 ug/day, subcutaneous, 18 months
DRUG	risedronate	35 mg/once weekly, oral, 18 months
DRUG	placebo	once weekly, oral, 18 months
DRUG	placebo	daily, subcutaneous, 18 months

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-06-01
• Completion: 2010-06-01
• First posted: 2006-06-22
• Last updated: 2011-05-26
• Results posted: 2010-07-12

Locations

72 sites across 13 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, Sweden