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

NCT ID: NCT00053560

Last Updated: 2008-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-08-31

Brief 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).

Conditions

Lupus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Prasterone (GL701)

Intervention Type: DRUG

Eligibility Criteria

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.
• Patients who are pregnant or breast feeding.
• Patients who require glucocorticoids by an alternate day dosing schedule.
• Known hypersensitivity to DHEA, or the inactive ingredients used in the GL701 formulation (cornstarch, lactose, magnesium stearate).
• Known medical contraindication or hypersensitivity to Calcium/Vitamin D.
• Participation in any prior DHEA or GL701 study.
• Use of investigational agents within 30 days of the Screening Visit or 10 half-lives of the agent.
• Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).
• The patient is taking or has taken one of the medications listed below:

ANTIRESORPTIVES:

• Use of calcitonin within 30 days prior to Screening Visit.
• Fluorides > 1 mg/day at any time prior to the study.
• Strontium at pharmacologic dose at any time.

BISPHOSPHONATE USE as follows:

• Any use within 90 days prior to the Screening Visit.
• ≥ 2 weeks of use in the last year prior to the Screening Visit.
• ≥ 3 months of use in the last 2 years prior to the Screening Visit.
• ≥ 1 intravenous dose over the last 2 years prior to the Screening Visit.
• ≥ 6 months of life-time exposure prior to the Screening Visit.

ESTROGENIC STEROIDS (Except for oral contraceptives):

• Estrogenic steroids (HRT) within 60 days of the Screening Visit.
• Selective estrogen receptor modulator (raloxifene) within 60 days of the Screening Visit.

OTHER HORMONES:

• Parathyroid hormone (PTH) within six months of the Screening Visit.
• Use of any androgens, including prescription or nutritional supplement DHEA, within 30 days of the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genelabs Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Genelabs Technologies, Inc.

Locations

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

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

St. John's Medical Research Group

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

North Shore University Hospital, Division of Rheumatology

Manhasset, New York, United States

Albert Einstein Medical School

The Bronx, New York, United States

Oklahoma Center for Arthritis Therapy

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Texas, Medical Branch

Galveston, Texas, United States

Sentara Medical Group DBA

Virginia Beach, Virginia, United States

Seattle Rheumatology Associates

Seattle, Washington, United States

Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.

Mexico City, , Mexico

Countries

United States; Mexico

References

Sanchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YR, McIlwain HH, Freeman PG, Aranow C, Petri MA, Deodhar AA, Blanton E, Manzi S, Kavanaugh A, Lisse JR, Ramsey-Goldman R, McKay JD, Kivitz AJ, Mease PJ, Winkler AE, Kahl LE, Lee AH, Furie RA, Strand CV, Lou L, Ahmed M, Quarles B, Schwartz KE. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. J Rheumatol. 2008 Aug;35(8):1567-75. Epub 2008 Jul 15.

Reference Type: DERIVED

PMID: 18634158 (View on PubMed)

Other Identifiers

GL02-01

Identifier Type: -

Identifier Source: org_study_id