Brief Summary

This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of long-term treatment with raloxifene on histomorphometry and bone quality in patients who participated in the Continuing Outcomes Relevant to Evista Study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Apr 2003

Shorter than P25 for phase_4

Geographic Reach

4 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

April 1, 2003

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed

4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed

Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

September 18, 2007

Last Update Submit

September 18, 2007

Conditions

Osteoporosis, Post-Menopausal

Outcome Measures

Primary Outcomes (1)

To determine the histomorphometric effects on bone,by iliac crest bone biopsy, of long-term (7 &8 yrs) therapy with raloxifene or placebo in postmenopausal women with osteoporosis who were enrolled in the CORE trial
6 months

Secondary Outcomes (1)

Find effect of long-term treatment with raloxifene or placebo on bone quality. Primary measures: primary mineralization defect absence, mean degree of mineralization of bone tissue, absence of woven bone, microCT, microcrack & nanoindentation analysis.
6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: Raloxifene

2

ACTIVE COMPARATOR

Drug: Raloxifene

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RaloxifeneDRUG

60 mg QD

Also known as: LY139481

PlaceboDRUG

Placebo

Eligibility Criteria

Age55 Years - 85 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have completed the CORE protocol within 3 months (90 days) prior to study entry and enrollment.
Have taken randomized study material for at least 7 years since enrollment in the MORE protocol. If the patient opted not to receive randomized study material for a period of 6 months at any point during either the MORE or CORE protocol, this period must have occurred in its entirety before Visit 3 of the CORE protocol.
Overall, were at least 75% compliant with randomized study material during the MORE and CORE protocols.

You may not qualify if:

Have undergone two previous transiliac bone biopsies (one in each iliac crest). Patients with one previous transiliac bone biopsy are eligible provided that the new sample is obtained from the contralateral iliac crest.
In the opinion of the investigator, have any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the procedure (for example, coagulation abnormality, extreme obesity, etc.).
Have a history of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
Have a history of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (7)

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.

Indianapolis, Indiana, United States

Location

Omaha, Nebraska, United States

Location

Mexico City, Mexico

Location

Amsterdam, Netherlands

Location

Barcelona, Spain

Location

Granada, Spain

Location

Oviedo, Spain

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

April 1, 2003

Study Completion

September 1, 2003

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

ME(1)US(2)NL(1)ES(3)

Long Term Effects of Raloxifene Treatment on Bone Quality

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations