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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
Est. primary completion date
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


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.
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