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

December 26, 2007 updated by: Genelabs Technologies

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14000
        • Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90048
        • Wallace Rheumatic Study Center
      • North Hollywood, California, United States, 91607
        • Peng T Fan, MD & Wonil Lee, MD Partnership
      • Rancho Mirage, California, United States, 92270
        • Lifestyles Health Science Center
      • San Diego, California, United States, 92093-0943
        • University of California San Diego
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Center for Rheumatology, Immunology and Arthritis
      • Orlando, Florida, United States, 32806-6264
        • Rheumatology Associates of Central Florida
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Missouri
      • Springfield, Missouri, United States, 65804
        • St. John's Medical Research Group
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Medical School
      • Brooklyn, New York, United States, 11203
        • Suny Downstate Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital, Division of Rheumatology
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Oklahoma Center for Arthritis Therapy
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of PIttsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas, Medical Branch
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sentara Medical Group DBA
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Rheumatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelabs Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

January 30, 2003

First Submitted That Met QC Criteria

February 1, 2003

First Posted (Estimate)

February 3, 2003

Study Record Updates

Last Update Posted (Estimate)

January 7, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL02-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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