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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00670319




Registration number
NCT00670319
Ethics application status
Date submitted
29/04/2008
Date registered
1/05/2008
Date last updated
1/05/2008

Titles & IDs
Public title
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Scientific title
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Secondary ID [1] 0 0
H3S-MC-GGGK
Secondary ID [2] 0 0
1363
Universal Trial Number (UTN)
Trial acronym
MORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Raloxifene HCL
Treatment: Drugs - Raloxifene HCL
Treatment: Drugs - Placebo

Experimental: 1 - Raloxifene HCL 60 mg orally once a day

Experimental: 2 - Raloxifene HCL 120 mg orally once a day

Placebo comparator: 3 -


Treatment: Drugs: Raloxifene HCL
Raloxifene HCL 60 mg orally once daily

Treatment: Drugs: Raloxifene HCL
Raloxifene HCL 120 mg orally once daily

Treatment: Drugs: Placebo
Placebo one tab orally per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Screening, 24, 36, and 72 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Screening, baseline, 12, 24, 36, 48, 60 and 72 months
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
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.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, 24 and 72 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial
Secondary outcome [3] 0 0
To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.
Timepoint [3] 0 0
Randomization, baseline, 6, 12, 24, 36, and 72 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, 6, 12, 24, 36, and 48 months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline, 3, 6, 12, 18, 24,30 and 36 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline, 12, 24, and 36 months
Secondary outcome [7] 0 0
To assess the impact of raloxifene on cognitive & neuropsychomotor function using a standardized battery of neuropsychometric tests.
Timepoint [7] 0 0
Cognitive/Neuropsychomotor assessments: Baseline, 6, 12, 24, 36, 48, 60 and 72 months
Secondary outcome [8] 0 0
To assess the impact of treatment with raloxifene on risk of cardiovascular disease by monitoring biochemical markers of cardiovascular risk.
Timepoint [8] 0 0
Baseline, 6, 12, 24, 36, and 48 months
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
GYN Exams and Uterine Ultrasound: Screening, 12, 24, 36, 48, 60 and 72 months.
Secondary outcome [10] 0 0
To assess the possible impact of long-term treatment with raloxifene on breast cancer.
Timepoint [10] 0 0
Mammograms: Screening, 24, 36,48 60 and 72 months
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Ongoing throughout the trial
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Ongoing throughout the trial
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Ongoing throughout the trial

Eligibility
Key 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.
Minimum age
No limit
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1994
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/1999
Sample size
Target
Accrual to date
Final
7705
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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. - Heidelburg
Recruitment postcode(s) [1] 0 0
- Heidelburg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad De Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Denmark
State/province [7] 0 0
Aarhus
Country [8] 0 0
Finland
State/province [8] 0 0
Turku
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
Germany
State/province [10] 0 0
Wiesbaden
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Israel
State/province [12] 0 0
Petach-Tiqva
Country [13] 0 0
Italy
State/province [13] 0 0
Firenze
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico City
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
Norway
State/province [17] 0 0
Haugesund
Country [18] 0 0
Poland
State/province [18] 0 0
Bialystok
Country [19] 0 0
Singapore
State/province [19] 0 0
Singapore
Country [20] 0 0
Slovakia
State/province [20] 0 0
Bratislava
Country [21] 0 0
Slovenia
State/province [21] 0 0
LjublJana
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Sweden
State/province [23] 0 0
Uppsala
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London Bridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00670319
Trial related presentations / publications
Melamed ML, Blackwell T, Neugarten J, Arnsten JH, Ensrud KE, Ishani A, Cummings SR, Silbiger SR. Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis. Kidney Int. 2011 Jan;79(2):241-9. doi: 10.1038/ki.2010.378. Epub 2010 Oct 6.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00670319