Effects of Teriparatide in Postmenopausal Women With Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: teriparatide (Drug); aldrenodate (Drug); raloxifene (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Summary
Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or
Raloxifene.
Clinical Details
Official title: Effects of Teriparatide in Postmenopausal Women With Osteoporosis Previously Treated With Alendronate or Raloxifene
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in calcium values after beginning teriparatide
Secondary outcome: Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
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
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
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
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
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
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
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
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
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
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2004
Last updated: May 23, 2007
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