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LupusPhase 3NCT00053560

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

A Phase 3 study testing Prasterone (GL701) in people with Lupus, run by Genelabs Technologies at 26 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lupus
What is being tested?
Prasterone (GL701)
How many people
155 participants
Where
26 sitesin 2 countries
Study dates
Dec 2002to Aug 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States25 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Northwestern University

    Chicago, Illinois, 60611

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33334

  • University of Texas, Medical Branch

    Galveston, Texas, 77555

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • North Shore University Hospital, Division of Rheumatology

    Manhasset, New York, 11030

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Peng T Fan, MD & Wonil Lee, MD Partnership

    North Hollywood, California, 91607

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806-6264

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Lifestyles Health Science Center

    Rancho Mirage, California, 92270

  • University of California San Diego

    San Diego, California, 92093-0943

  • East Bay Rheumatology Group

    San Leandro, California, 94578

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

  • St. John's Medical Research Group

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Albert Einstein Medical School

    The Bronx, New York, 10461

  • University of Arizona

    Tucson, Arizona, 85724

  • Oklahoma Center for Arthritis Therapy

    Tulsa, Oklahoma, 74114

  • Sentara Medical Group DBA

    Virginia Beach, Virginia, 23462

Other trials in United States

Mexico1 site

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

    Mexico City, 14000

Other trials in Mexico

About this 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

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
Being tested
Prasterone (GL701)
Keywords
lupus, systemic lupus erythematosus, SLE, bone loss, DHEA
Medical subject headings
Lupus Erythematosus, Systemic, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prasterone (GL701)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2003 (estimated)
  2. Study startDec 2002
  3. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
155 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053560
Sponsor's protocol ID
GL02-01
Status last verified
Nov 2004
First submitted
30 Jan 2003
Last updated
7 Jan 2008
Results posted
No

Publications

  • 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.

    PubMed 18634158

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasterone (GL701) in people with Lupus, run by Genelabs Technologies at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00053560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2008.

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