Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191425
Status:
COMPLETED
Last Update Posted:
2007-07-16
First Post:
2005-09-12
Brief Title:
2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or CalciumVit D in Severe Postmenopausal Osteoporosis
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatideIn the first yearall eligible patients received open-label teriparatide 20 microgramsdayAfter 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 treatmentother 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 microgramsday throughout the second year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B3D-EW-GHCA | None | None | None |