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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by Genelabs Technologies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Genelabs Technologies
ClinicalTrials.gov Identifier:
NCT00053560
First received: January 30, 2003
Last updated: December 26, 2007
Last verified: November 2004
  Purpose

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).


Condition Intervention Phase
Lupus
Drug: Prasterone (GL701)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Genelabs Technologies:

Estimated Enrollment: 155
Study Start Date: December 2002
Estimated Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 26 Study Locations
Sponsors and Collaborators
Genelabs Technologies
  More Information

No publications provided by Genelabs Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth E. Schwartz, MD/Vice President, Medical Affairs, Genelabs Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00053560     History of Changes
Other Study ID Numbers: GL02-01
Study First Received: January 30, 2003
Last Updated: December 26, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Genelabs Technologies:
lupus
systemic lupus erythematosus
SLE
bone loss
DHEA

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dehydroepiandrosterone
Glucocorticoids
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014