Effects of Teriparatide in Postmenopausal Women With Osteoporosis
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00079924
First received: March 18, 2004
Last updated: May 23, 2007
Last verified: May 2007
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Purpose
Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopausal Osteoporosis |
Drug: teriparatide Drug: aldrenodate Drug: raloxifene |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Teriparatide in Postmenopausal Women With Osteoporosis Previously Treated With Alendronate or Raloxifene |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change in calcium values after beginning teriparatide
Secondary Outcome Measures:
- Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2004 |
| Study Completion Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal women aged at least 50 years
- A previous clinical diagnosis of osteoporosis
- At high risk for fracture
- Current therapy for at least 18 months prior to study entry with either raloxifene HCl or alendronate Na
Exclusion Criteria:
- History of metabolic bone disease other than osteoporosis
- History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079924
Locations
| United States, Alabama | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Birmingham, Alabama, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Scottsdale, Arizona, United States | |
| United States, Florida | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Jacksonville, Florida, United States | |
| United States, Georgia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Gainesville, Georgia, United States | |
| United States, Iowa | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Des Moines, Iowa, United States | |
| United States, Minnesota | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Rochester, Minnesota, United States | |
| United States, New York | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| West Haverstraw, New York, United States | |
| United States, North Carolina | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Charlotte, North Carolina, United States | |
| United States, Oklahoma | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Tulsa, Oklahoma, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00079924 History of Changes |
| Other Study ID Numbers: | 8141, B3D-MC-GHCM |
| Study First Received: | March 18, 2004 |
| Last Updated: | May 23, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Teriparatide Raloxifene Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013