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Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00670319•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 80 years

Sex

FEMALE

Healthy Volunteers

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
+12 more criteria

Locations (25)

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

Ciudad de Buenos Aires, Argentina

Heidelburg, Australia

Graz, Austria

Brussels, Belgium

London, Ontario, Canada

Prague, Czechia

Aarhus, Denmark

Turku, Finland

Lyon, France

Key Dates

Start Date

November 1, 1994

Primary Completion Date

September 1, 1999

Completion Date

September 1, 1999

Last Updated

May 1, 2008

Enrollment

7,705

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

Raloxifene HCL

DRUG

Raloxifene HCL

DRUG

Placebo

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

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RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects