- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670319
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis (MORE)
April 30, 2008 updated by: Eli Lilly and Company
To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7705
Phase
- Phase 3
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
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Ciudad De Buenos Aires, Argentina
- 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.
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Heidelburg, Australia
- 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.
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Graz, Austria
- 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.
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Brussels, Belgium
- 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.
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Ontario
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London, Ontario, Canada
- 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.
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Praha, Czech Republic
- 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.
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Aarhus, Denmark
- 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.
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Turku, Finland
- 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.
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Lyon, France
- 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.
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Wiesbaden, Germany
- 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.
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Budapest, Hungary
- 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.
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Petach-Tiqva, Israel
- 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.
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Firenze, Italy
- 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.
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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.
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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.
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Christchurch, New Zealand
- 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.
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Haugesund, Norway
- 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.
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Bialystok, Poland
- 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.
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Singapore, Singapore
- 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.
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Bratislava, Slovakia
- 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.
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LjublJana, Slovenia
- 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.
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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.
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Uppsala, Sweden
- 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.
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London Bridge, United Kingdom
- 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.
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California
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San Francisco, 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.
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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
No older than 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Ambulatory postmenopausal women free of severe or chronically disabling conditions, have a life expectancy of at least 5 years, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
- Women who have had their last menstrual period at least 2 years before beginning the study.
- Women who have no language barrier, are cooperative, and who give informed consent before entering the study
- Substudy 1:Femoral neck or lumbar spine BMD measurements 2.5 or more standard deviations below normal peak bone mass for healthy, premenopausal women (T-score greater then or equal to 2.5).
- Substudy 2:Either at least one moderate or at least two mild vertebral fractures in the presence of low BMD (as specified above) or at least two moderate vertebral fractures, regardless of BMD.
Exclusion Criteria:
- Patients with known current bone disorders other than primary osteoporosis, such as hyperparathyroidism, Paget's disease, renal osteodystrophy, or osteomalacia
- Patients experiencing clinically severe postmenopausal symptoms at the beginning of the study that require estrogen-replacement therapy
- Patients with known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia
- Patients who have had any history of cancer within the previous 5 years
- Patients with abnormal uterine bleeding
- Patients with a history of deep venous thrombosis, thromboembolic disorders, or cerebral vascular accident within the past 10 years except for patients with a history of deep venous thrombosis due to accidents
- Patients who have endocrine disorders requiring pharmacologic therapy except for type II diabetes
- Patients who are not biochemically euthyroid or who have had changes in thyroid replacement therapy in the 2 months before the start of the study.
- Patients with acute or chronic liver disease
- Patients who have impaired kidney function
- Patients with active renal lithiasis
- Patients with known, severe untreated malabsorption syndromes
- Patients with pathologic fractures (both substudies) or patients in Substudy II all of whose vertebral fractures are clearly a result of automobile accidents or other severely traumatic accidents
- Patients in whom satisfactory baseline thoracic and lumbar x-ray views cannot be obtained
- Patients with less than two lumbar and less than four thoracic vertebrae that are unfractured and evaluable for incident fractures
- Treatment with therapeutic doses of any of the following medications more recently than 6 months before beginning the study: Androgen, Calcitonin, Estrogen, Progestin
- Treatment with therapeutic doses of systemic corticosteroids for more than 1 month during the 12 months before beginning the study.
- Patients who have received therapeutic doses of fluorides
- Patients who have received bisphosphonate therapy for more than 14 days during the past 18 months or who have received any bisphosphonate therapy within the last 6 months before beginning the study.
- Patients requiring high-dose heparinization (>7500 U/day) at study entry for a total period of time that will presumably exceed 6 months
- Patients being treated with 50,000 IU or more of vitamin D once weekly more recently than 3 months before beginning the study will be excluded.
- Current systemic treatment with any of the following medications at the beginning of the study: Lithium, Anticonvulsants, regular use of phosphate-binding antacids.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 3
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Placebo one tab orally per day
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Experimental: 1
Raloxifene HCL 60 mg orally once a day
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Raloxifene HCL 60 mg orally once daily
Other Names:
Raloxifene HCL 120 mg orally once daily
Other Names:
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Experimental: 2
Raloxifene HCL 120 mg orally once a day
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Raloxifene HCL 60 mg orally once daily
Other Names:
Raloxifene HCL 120 mg orally once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To establish the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without prevalent vertebral fractures by spinal x-ray.
Time Frame: Screening, 24, 36, and 72 months
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Screening, 24, 36, and 72 months
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To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.
Time Frame: Screening, baseline, 12, 24, 36, 48, 60 and 72 months
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Screening, baseline, 12, 24, 36, 48, 60 and 72 months
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To establish the safety of chronic administration of raloxifene in postmenopausal women with osteoporosis. Adverse events (AEs), physical exam (PE), EKG, mammograms and laboratory tests will be used to assess safety in the patients.
Time Frame: AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.
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AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To establish the effect of long-term treatment with raloxifene, compared with placebo, on total body bone mineral content and radial BMD in postmenopausal women with osteoporosis.
Time Frame: Baseline, 24 and 72 months
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Baseline, 24 and 72 months
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To establish the effect of raloxifene, compared with placebo, on the rates of new nonvertebral fractures alone & of nonvertebral & vertebral fractures combined in postmenopausal women with osteoporosis by spinal x-ray & assessment of clinical fractures.
Time Frame: Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial
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Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial
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To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.
Time Frame: Randomization, baseline, 6, 12, 24, 36, and 72 months
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Randomization, baseline, 6, 12, 24, 36, and 72 months
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To establish the effect of long-term treatment with raloxifene, compared with placebo, on serum lipids and other laboratory markers of cardiovascular risk in postmenopausal women with osteoporosis.
Time Frame: Baseline, 6, 12, 24, 36, and 48 months
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Baseline, 6, 12, 24, 36, and 48 months
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To quantify medical resources utilized by patients treated with raloxifene so that a subsequent incremental cost-effectiveness analysis can be performed by quantifying overnight hospitalizations or osteoporotic fractures.
Time Frame: Baseline, 3, 6, 12, 18, 24,30 and 36 months
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Baseline, 3, 6, 12, 18, 24,30 and 36 months
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To assess the impact of raloxifene on quality of life in osteoporotic women with prevalent vertebral fractures by the completion of Quality of Life instruments.
Time Frame: Baseline, 12, 24, and 36 months
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Baseline, 12, 24, and 36 months
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To assess the impact of raloxifene on cognitive & neuropsychomotor function using a standardized battery of neuropsychometric tests.
Time Frame: Cognitive/Neuropsychomotor assessments: Baseline, 6, 12, 24, 36, 48, 60 and 72 months
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Cognitive/Neuropsychomotor assessments: Baseline, 6, 12, 24, 36, 48, 60 and 72 months
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To assess the impact of treatment with raloxifene on risk of cardiovascular disease by monitoring biochemical markers of cardiovascular risk.
Time Frame: Baseline, 6, 12, 24, 36, and 48 months
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Baseline, 6, 12, 24, 36, and 48 months
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To assess the possible impact of long-term treatment with raloxifene on risks of endometrial cancer by pelvic gynecological exams and by use of uterine ultrasound in a subset of patients.
Time Frame: GYN Exams and Uterine Ultrasound: Screening, 12, 24, 36, 48, 60 and 72 months.
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GYN Exams and Uterine Ultrasound: Screening, 12, 24, 36, 48, 60 and 72 months.
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To assess the possible impact of long-term treatment with raloxifene on breast cancer.
Time Frame: Mammograms: Screening, 24, 36,48 60 and 72 months
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Mammograms: Screening, 24, 36,48 60 and 72 months
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To determine the effect of treatment with raloxifene on the prevalence of Alzheimer's disease (AD) on subjects by using a Dementia Diagnostic Evaluation which includes a battery of tests and interviews with the patient as well as brain CT or MRI scan.
Time Frame: Ongoing throughout the trial
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Ongoing throughout the trial
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To determine the effect of long-term treatment with raloxifene on the prevalence of dementia associated with cerebrovascular (CV) disease in postmenopausal women with osteoporosis by administration of the dementia diagnosis.
Time Frame: Ongoing throughout the trial
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Ongoing throughout the trial
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Determine the effect of raloxifene on the prevalence of all causes of dementia in subjects by using a Dementia Diagnostic Evaluation which includes a battery of tests and interviews with the patient as well as brain CT or MRI scan.
Time Frame: Ongoing throughout the trial
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Ongoing throughout the trial
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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.
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
November 1, 1994
Primary Completion (Actual)
September 1, 1999
Study Completion (Actual)
September 1, 1999
Study Registration Dates
First Submitted
April 29, 2008
First Submitted That Met QC Criteria
April 30, 2008
First Posted (Estimate)
May 1, 2008
Study Record Updates
Last Update Posted (Estimate)
May 1, 2008
Last Update Submitted That Met QC Criteria
April 30, 2008
Last Verified
April 1, 2008
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
- 1363 (Clinical Research Center)
- H3S-MC-GGGK
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.
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