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Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

NCT ID: NCT00670319

Last Updated: 2008-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7705 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Study Completion Date

1999-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Raloxifene HCL 60 mg orally once a day

Group Type EXPERIMENTAL

Raloxifene HCL

Intervention Type DRUG

Raloxifene HCL 60 mg orally once daily

2

Raloxifene HCL 120 mg orally once a day

Group Type EXPERIMENTAL

Raloxifene HCL

Intervention Type DRUG

Raloxifene HCL 120 mg orally once daily

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo one tab orally per day

Interventions

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Raloxifene HCL

Raloxifene HCL 60 mg orally once daily

Intervention Type DRUG

Raloxifene HCL

Raloxifene HCL 120 mg orally once daily

Intervention Type DRUG

Placebo

Placebo one tab orally per day

Intervention Type DRUG

Other Intervention Names

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Evista LY139481 Evista LY139481

Eligibility Criteria

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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.
Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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 Francisco, California, United States

Site Status

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Ciudad de Buenos Aires, , Argentina

Site Status

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Heidelburg, , Australia

Site Status

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Graz, , Austria

Site Status

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Brussels, , Belgium

Site Status

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London, Ontario, Canada

Site Status

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Prague, , Czechia

Site Status

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Aarhus, , Denmark

Site Status

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Turku, , Finland

Site Status

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Lyon, , France

Site Status

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Wiesbaden, , Germany

Site Status

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Budapest, , Hungary

Site Status

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Petach-Tiqva, , Israel

Site Status

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Florence, , Italy

Site Status

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Mexico City, , Mexico

Site Status

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Amsterdam, , Netherlands

Site Status

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Christchurch, , New Zealand

Site Status

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Haugesund, , Norway

Site Status

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Bialystok, , Poland

Site Status

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Singapore, , Singapore

Site Status

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Bratislava, , Slovakia

Site Status

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Ljubljana, , Slovenia

Site Status

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Barcelona, , Spain

Site Status

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Uppsala, , Sweden

Site Status

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London Bridge, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Canada Czechia Denmark Finland France Germany Hungary Israel Italy Mexico Netherlands New Zealand Norway Poland Singapore Slovakia Slovenia Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20927038 (View on PubMed)

Other Identifiers

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H3S-MC-GGGK

Identifier Type: -

Identifier Source: secondary_id

1363

Identifier Type: -

Identifier Source: org_study_id