Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Postmenopausal
Intervention: teriparatide (Drug); raloxifene HCl (Drug); placebo (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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The purpose of this study is to determine whether the increase in spine bone mineral density
that has been generally observed in previous clinical studies involving the study drug can be
maintained or even increased if followed with raloxifene HCl. All qualifying study
participants will receive the study drug followed by treatment with raloxifene HCl or
placebo. All study participants will receive raloxifene HCl in the third phase of the
study.
Clinical Details
Official title: Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The study is designed to compare the effect of 1 year of raloxifene treatment with the effect of placebo on maintaining teriparatide-induced increases in spine and hip BMD.
Secondary outcome: An open-label treatment phase will extend the study for 1 year beyond the primary endpoint. During this final year of the study all patients will receive raloxifene.The purpose of lengthening is to assess the differences in response to raloxifene when it is administered immediately following versus 1 year after(with and without a washout period) withdrawal from teriparatide.
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Must be diagnosed with osteoporosis
- Must be female, age 55 through 80
- Must be at least 5 years postmenopausal
- Must be free of other severe or chronically disabling conditions
- Must be able to properly use injection device.
Exclusion Criteria:
- Must not have bone diseases other than osteoporosis
- Must not have history of certain cancers
- Must not have certain medical diseases (inflammatory bowel disease, malabsorption
syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding
due to unknown causes)
- Must not have treatment with particular medications (warfarin, estrogens, androgens,
steroids, calcitonins, fluorides, biphosphonates)
- Must not have known allergy to the study agent or raloxifene HCl
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Maywood, Illinois, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Kitchener, Ontario, Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, London, Ontario, Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Portland, Oregon, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Sainte -Foy, Quebec, Canada
Additional Information
Starting date: October 2001
Ending date: July 2005
Last updated: May 11, 2007
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