NCT00191425

2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

Comparison of a 2-Year Therapy of Teriparatide Alone and Its Sequential Use for 1 Year, With or Without Raloxifene HCl, in the Treatment of Severe Postmenopausal Osteoporosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 810 (planned)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Teriparatide
DRUG	Raloxifene

Timeline

• Start date: 2002-08-01
• Completion: 2005-11-01
• First posted: 2005-09-19
• Last updated: 2007-07-16

Locations

1 site across 1 country: Germany