NCT00670501

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,637 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	teriparatide	40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
DRUG	teriparatide	20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
DRUG	Placebo	Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
DRUG	Calcium Supplement	Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
DRUG	Vitamin D Supplement	Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

Timeline

• Start date: 1996-08-01
• Primary completion: 1999-04-01
• Completion: 1999-04-01
• First posted: 2008-05-01
• Last updated: 2008-05-01

Locations

17 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Sweden