2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis
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|ClinicalTrials.gov Identifier: NCT00191425|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal||Drug: Teriparatide Drug: Raloxifene||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||810 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2002|
|Estimated Study Completion Date :||November 2005|
- Lumbar spine BMD after 24 months.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191425
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|Bad Pyrmont, Germany, D-31812|
|Study Chair:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|