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OpenTrials
Completed

NCT Number: NCT00532246

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

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

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Key information

Conditions

Osteoporosis, Post-Menopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Have previously withdrawn from this exploratory study or any other study investigating raloxifene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

Treatment and study plan

Raloxifene

Drug

Other names: LY139481

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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:

  2. 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.

  3. All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE

  4. All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2003
First posted
Sep 20, 2007
Registry last updated
Sep 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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