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A Study of Arzoxifene to Treat Korean Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Arzoxifene to Treat Korean Women With Osteoporosis

Effects of Arzoxifene on Bone Mineral Density in Korean Postmenopausal Women With Osteoporosis

NCT00767299•Eli Lilly and Company

Summary

The study is for Korean women who are postmenopausal and also suffer from osteoporosis. The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene. All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.

Eligibility

Age

60 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture.
•Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed osteoporosis (Inclusion Criterion \[1\]), all women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
•Had their last natural menstrual period at least 2 years before beginning the study.
•Are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
•Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening.
•Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal to -2.5

Exclusion Criteria

•Have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia.
•Have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. For other cancers, be disease free and in remission from all other cancers for 5 or more years, except for excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma of the skin.
•Have demonstrated or suspected allergy to raloxifene or arzoxifene
•Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or between Visit 1 and Visit 2.
•Are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy.
•Have a history of or suggestion on ultrasound or pelvic examination of a pre-existing gynecologic abnormality that would require further gynecologic treatment (e.g., ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial thickness of \>5 mm.
•Have Papanicolaou's tests showing malignant or premalignant findings.
•Have active or any past history of thromboembolic events
•Have active or any past history of atrial fibrillation.
•Have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past.
+8 more criteria

Locations (2)

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.

Bucheon-si, South Korea

Seoul, South Korea

Key Dates

Start Date

December 1, 2008

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

April 30, 2015

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

arzoxifene

DRUG

Placebo

DRUG

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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: April 30, 2015Data 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.

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A Study of Arzoxifene to Treat Korean Women With Osteoporosis

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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