Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

Osteoporosis, Postmenopausal Clinical Trial

Official title:

Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035256
• Other study ID #: 5490
• Secondary ID: B3D-MC-GHBQ
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2002
• Last updated: May 11, 2007
• Start date: October 2001
• Est. completion date: July 2005

Study information

• Verified date: May 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• teriparatide

• raloxifene HCl

• placebo

Locations

Country	Name	City	State
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	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	Sainte -Foy	Quebec
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	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	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.