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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00191425 |
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.
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: Teriparatide Drug: Raloxifene |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 810 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | November 2005 |
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may be included in substudy 2 if they meet any one of the following additional criteria - Patients who have sustained at least one new fragility fracture (vertebral or nonvertebral), despite prescription of antiresorptive therapy* during the 12 months prior to the last new fracture or patients who, after a minimum of two years after initiating antiresorptive therapy*, either have a lumbar spine, femoral neck, or total hip BMD of at least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a decrease of at least 3.5% in BMD at any one of these sites.
*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and vitamin D metabolites.
Exclusion Criteria:
For substudy 1 patients only:
Treatment with
Germany | |
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 |
Study ID Numbers: | 6537, B3D-EW-GHCA |
Study First Received: | September 12, 2005 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00191425 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Directorate general for the protection of Public health: Medicines; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Greece: National Organization of Medicines; Spain: Spanish Agency of Medicines; Portugal: National Pharmacy and Medicines Institute; Austria: Federal Ministry for Health and Women |
Calcium, Dietary Raloxifene Musculoskeletal Diseases Teriparatide |
Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Estrogen Receptor Modulators Estrogen Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions |