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Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00532545 |
To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population
Condition | Intervention | Phase |
---|---|---|
Osteoporosis, Post-Menopausal |
Drug: Teriparatide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis |
Enrollment: | 45 |
Study Start Date: | April 2003 |
Study Completion Date: | April 2004 |
Arms | Assigned Interventions |
---|---|
A: Experimental
Teriparatide
|
Drug: Teriparatide
Teriparatide 20 micrograms/daily subcutaneously
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Bayamon, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Carolina, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Fajardo, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Caguas, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
San Juan, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Ponce, Puerto Rico | |
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Humacao, Puerto Rico |
Study Director: | 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: | 6715, B3D-SU-S001 |
Study First Received: | September 18, 2007 |
Last Updated: | September 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00532545 |
Health Authority: | United States: Food and Drug Administration |
Musculoskeletal Diseases Teriparatide Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Menopause |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |