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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2002

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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