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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
Est. primary completion date
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- Have previously withdrawn from this exploratory study or any other study investigating raloxifene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


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
See also
  Status Clinical Trial Phase
Completed NCT00532207 - Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis Phase 3
Completed NCT00018447 - Combination Osteogenic Therapy in Established Osteoporosis Phase 2
Completed NCT00543023 - A Study of the Treatment of Postmenopausal Women With Osteoporosis Phase 3
Completed NCT00927186 - Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women Phase 4
Completed NCT00543218 - PTH Comparison in Post Menopausal Women Phase 3
Completed NCT00532428 - Long Term Effects of Raloxifene Treatment on Bone Quality Phase 4
Completed NCT00532545 - Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis Phase 4

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