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


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  • Purpose

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    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).


    status: active, not recruiting
    conditions: Lupus
    interventions: Prasterone (GL701)
    phase: Phase 3
    study type: Interventional
    study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
    official title: 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

  • Further study details (as provided by Genelabs Technologies)

    enrollment: 155

    study start date: December 2002

    study completion date: August 2004


  • Eligibility

    ages eligible for study: 18 Years and older
    genders eligible for study: Female

    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.

  • Contacts and locations

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00053560

    Locations

    United States , Arizona  - University of Arizona

    facility: Tucson, Arizona, United States, 85724

    United States , California  - Wallace Rheumatic Study Center

    facility: Los Angeles, California, United States, 90048

    United States , California  - East Bay Rheumatology Group

    facility: San Leandro, California, United States, 94578

    United States , California  - Lifestyles Health Science Center

    facility: Rancho Mirage, California, United States, 92270

    United States , California  - University of California San Diego

    facility: San Diego, California, United States, 92093-0943

    United States , California  - Peng T Fan, MD & Wonil Lee, MD Partnership

    facility: North Hollywood, California, United States, 91607

    United States , Florida  - Rheumatology Associates of Central Florida

    facility: Orlando, Florida, United States, 32806-6264

    United States , Florida  - Tampa Medical Group, P.A.

    facility: Tampa, Florida, United States, 33614

    United States , Florida  - Center for Rheumatology, Immunology and Arthritis

    facility: Fort Lauderdale, Florida, United States, 33334

    United States , Illinois  - Northwestern University

    facility: Chicago, Illinois, United States, 60611

    United States , Louisiana  - Ochsner Clinic Foundation

    facility: New Orleans, Louisiana, United States, 70121

    United States , Maryland  - Johns Hopkins University

    facility: Baltimore, Maryland, United States, 21205

    United States , Missouri  - Washington University School of Medicine

    facility: St. Louis, Missouri, United States, 63110

    United States , Missouri  - St. John's Medical Research Group

    facility: Springfield, Missouri, United States, 65804

    United States , New York  - Albert Einstein Medical School

    facility: Bronx, New York, United States, 10461

    United States , New York  - SUNY Downstate Medical Center

    facility: Brooklyn, New York, United States, 11203

    United States , New York  - North Shore University Hospital, Division of Rheumatology

    facility: Manhasset, New York, United States, 11030

    United States , Oklahoma  - Oklahoma Center for Arthritis Therapy

    facility: Tulsa, Oklahoma, United States, 74114

    United States , Oregon  - Oregon Health & Science University

    facility: Portland, Oregon, United States, 97201

    United States , Pennsylvania  - University of Pittsburgh

    facility: Pittsburgh, Pennsylvania, United States, 15261

    United States , Pennsylvania  - Altoona Center for Clinical Research

    facility: Duncansville, Pennsylvania, United States, 16635

    United States , Tennessee  - Vanderbilt University

    facility: Nashville, Tennessee, United States, 37232

    United States , Texas  - University of Texas, Medical Branch

    facility: Galveston, Texas, United States, 77555

    United States , Virginia  - Sentara Medical Group DBA

    facility: Virginia Beach, Virginia, United States, 23462

    United States , Washington  - Seattle Rheumatology Associates

    facility: Seattle, Washington, United States, 98104

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

    facility: Mexico City, Mexico, 14000

  • Sponsors and collaborators

    Genelabs Technologies

  • More information

    first received: January 30, 2003
    last updated: December 26, 2007
    ClinicalTrials.gov Identifier: NCT00053560
    health authority: United States: Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

© 2009 NextBio