- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00532428
Long Term Effects of Raloxifene Treatment on Bone Quality
September 18, 2007 updated by: Eli Lilly and Company
Long-Term Effects of Raloxifene Treatment on Bone Quality: A Cross-Sectional Study of Postmenopausal Women With Osteoporosis Previously Enrolled in the Continuing Outcomes Relevant to Evista Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mexico City, Mexico
- 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.
-
-
-
-
-
Amsterdam, Netherlands
- 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.
-
-
-
-
-
Barcelona, Spain
- 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.
-
Granada, Spain
- 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.
-
Oviedo, Spain
- 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.
-
-
-
-
Indiana
-
Indianapolis, Indiana, 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.
-
-
Nebraska
-
Omaha, Nebraska, 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.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Have an allergy or other intolerance to tetracycline hydrochloride that would preclude its administration in conjunction with the bone biopsy procedures. If the patient is not allergic to all tetracyclines, then this exclusion may be waived by the sponsor and a different tetracycline to which the patient is not allergic may be used.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
60 mg QD
Other Names:
120 mg QD
Other Names:
|
Active Comparator: 1
|
60 mg QD
Other Names:
120 mg QD
Other Names:
|
Placebo Comparator: 3
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
September 1, 2003
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 20, 2007
Study Record Updates
Last Update Posted (Estimate)
September 20, 2007
Last Update Submitted That Met QC Criteria
September 18, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Osteoporosis, Postmenopausal
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Raloxifene Hydrochloride
Other Study ID Numbers
- 8149
- H3S-MC-GGLF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoporosis, Post-Menopausal
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisAustralia, United Kingdom, United States, Brazil, Germany, South Africa, France, Spain, Switzerland, Italy, Canada, Hungary, Belgium, Mexico, Poland, Denmark, Norway, Czechia, Romania
-
University College, LondonWithdrawnPost-menopausal OsteoporosisUnited Kingdom
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisPhilippines, Taiwan, Thailand, Hong Kong, Indonesia
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisBosnia and Herzegovina
-
NovartisCompletedPost-menopausal OsteoporosisGermany, Denmark
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States