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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome: Lumbar spine BMD after 24 months.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hip and femoral neck BMD at 24 months.
  • Comparison of randomized groups, and descriptive analysis of group receiving open-label treatment with teriparatide for 2 years due to prior antiresorptive treatment failure.
  • Change in itudinal fracture pattern from 3-year pre-study period to end of the study in all patients who receive teriparatide for 2 years.
  • Change in back pain after 1, 6, 12, and 24 mths.
  • Safety of teriparatide.


Original Secondary Outcome: Same as current

Information By: Eli Lilly and Company

Dates:
Date Received: September 12, 2005
Date Started: August 2002
Date Completion: November 2005
Last Updated: July 12, 2007
Last Verified: July 2007