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To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids | Clinical Trials | Clareo Health

UNKNOWNPHASE3

To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

NCT00053560•Genelabs Technologies

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to study the effects of GL701 on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women at least 18 years of age.
•Meet ACR criteria for diagnosis of SLE.
•Concomitant treatment with prednisone at a dose of ≥5 mg/day over the last 30 days prior to Screening visit.
•Cumulative history of oral glucocorticoid use for at least 6 months over the last year prior to the Screening Visit (the 6 months do not have to be consecutive).
•Patient has lumbar spine and proximal femur anatomy suitable for measurement by DXA with at least 3 evaluable vertebrae from L1 to L4.
•SLEDAI ≥3 at the Qualifying Visit.
•Women of child-bearing potential must have a negative serum pregnancy test (at the Screening Visit) and agree to use a reliable form of birth control while participating in the study.
•Patient is fully ambulatory.
•Patient has read and signed an Informed Consent Form.

Exclusion Criteria

•History of breast cancer or malignancy of the reproductive tract organs.
•History of any other cancers unless no evidence of disease for 5 years.
•History of endometrial hyperplasia.
•End stage renal disease or receiving hemodialysis treatment.
•Any disease or condition that would preclude the accurate measurement of bone mineral density of the lumbar spine or proximal femur by dual X-ray absorptiometry.
•A T-score of less than or equal to - 2.5 of the L-spine or proximal femur at Screening DXA assessment.
•Unstable cardiac disease.
•Conditions causing bone loss such as hyperparathyroidism, Cushing's disease, thyrotoxicosis, chronic diarrheal state or malabsorption, renal tubular acidosis, or anorexia nervosa.
•Significant hepatic disease (i.e., cirrhosis).
•Body mass index \> 35 kg/m2 or weight \>300 lbs.
+24 more criteria

Locations (26)

University of Arizona

Tucson, Arizona, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

Peng T Fan, MD & Wonil Lee, MD Partnership

North Hollywood, California, United States

Lifestyles Health Science Center

Rancho Mirage, California, United States

University of California San Diego

San Diego, California, United States

East Bay Rheumatology Group

San Leandro, California, United States

Center for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

Rheumatology Associates of Central Florida

Orlando, Florida, United States

Tampa Medical Group, P.A.

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

December 1, 2002

Completion Date

August 1, 2004

Last Updated

January 7, 2008

Enrollment

155

Estimated participants

Conditions

Lupus

Interventions

Prasterone (GL701)

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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: January 7, 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.

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To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

Inclusion Criteria

Exclusion Criteria

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