Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo

Osteoporosis, Post-Menopausal Clinical Trial

Official title:

A Study of Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene HCl or Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532246
• Other study ID #: 8135
• Secondary ID: H3S-MC-GGLE
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2007
• Last updated: September 18, 2007
• Start date: March 2003
• Est. completion date: August 2003

Study information

• Verified date: September 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 measure carotid artery IMT at a single visit in a subset of women previously enrolled in the CORE (H3S-MC-GGJY) trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Patients must have completed the Eli Lilly and Company clinical trial CORE (H3S-MC-GGJY) inclusive of visit 5, in one of the 9 participating study sites in California.

• Patients must have been dispensed study drug in the CORE trial (H3S-MC-GGJY).

Exclusion Criteria:

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

• Have previously withdrawn from this exploratory study or any other study investigating raloxifene

• Are employed by Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Eli Lilly and Company employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly and Company facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

• Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis, Post-Menopausal
• Osteoporosis, Postmenopausal

Intervention

Drug:
• raloxifene

• Placebo

Locations

Country	Name	City	State
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Jolla	California
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Menlo Park	California
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oakland	California
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Diego	California
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the hypothesis that in postmenopausal women with osteoporosis who took lipid lowering meds for more than 6 months > 80% compliant with study drug during CORE trial, mean carotid IMT will be lower in patients treated with raloxifene than placebo
Secondary	To test the hypothesis that, in postmenopausal women with osteoporosis, mean carotid IMT will be significantly lower in patients treated with raloxifene as compared to mean carotid IMT in patients treated with placebo in the following:
Secondary	All enrolled patients who have not been exposed to lipid lowering medication for more than 6 months while in the CORE trial, regardless of study drug compliance.
Secondary	All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE
Secondary	All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy

External Links

•   Lilly Clinical Trial Registry