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Trial record 50 of 236 for:    PRASTERONE

Hormonal Therapy for Teens With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01343771
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine M. Gordon, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE April 20, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Bone Marrow Fat by MRI/MRS [ Time Frame: Baseline; M12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01343771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • BMD by DXA (spine, hip, whole body) [ Time Frame: Baseline; M6; M12 ]
  • Bone biomarkers [ Time Frame: Baseline; M3; M6; M9; M12 ]
  • BMD by pQCT of tibia [ Time Frame: Baseline; M6; M12 ]
  • Hormonal panel (serum) [ Time Frame: Baseline; M3; M6; M9; M12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormonal Therapy for Teens With Anorexia Nervosa
Official Title  ICMJE Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular BMD
Brief Summary The following randomized controlled trial will examine the effects of one year of dehydroepiandrosterone and estrogen replacement therapy (DHEA +ERT) on bone mineral density (BMD) and bone marrow composition in adolescents with anorexia nervosa (AN). The investigators will use imaging techniques including dual-energy x-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), visual assessments of magnetic resonance imaging (MRI) data, MR relaxometry and magnetic resonance spectroscopy (MRS) to measure bone mineral density and evaluate bone marrow composition. The investigators will also collect serum to measure hormonal mediators of the changes observed in both bone density and bone marrow composition, including adrenal and gonadal steroids, insulin-like growth factors, growth hormone, and ghrelin, adiponectin, and leptin.
Detailed Description

This double-blinded randomized controlled trial will include 2 treatment arms of 35 patients. Group 1 will receive micronized oral DHEA in a dose of 50 mg daily + ERT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse, 20 mg ethinyl estradiol + 0.1 mg levonorgestrel for 9 months); and Group 2 will receive placebo.There will be 12 months of therapy with follow up assessments every 3 months. DXA and pQCT measurements will be obtained at baseline, 6 months, and 12 months; MRI and MRS will be performed at baseline and 1 year; serum samples will be obtained at baseline and every 3 months throughout the 12-month trial; psychological and nutrition surveys will be carried out at baseline, 6, and 12 months.

The investigators anticipate that this study will enable us to evaluate the efficacy of oral DHEA + ERT as a treatment strategy to optimize peak bone mass and to prevent development of osteoporosis in patients with AN.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa (AN)
Intervention  ICMJE
  • Drug: DHEA (Prasterone) + ERT (Aviane)
    Micronized oral DHEA in a dose of 50 mg daily + ERT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse, 20 mcg ethinyl estradiol + 0.1 mg levonorgestrel for 9 months)
    Other Names:
    • Dehydroepiandrosterone (DHEA)
    • Estrogen Replacement Therapy (ERT)
  • Other: Placebo
    A placebo tablet will be developed by the Children's Hospital Pharmacy. Both treatments (DHEA+ERT and placebo) will be administered in a gelatin capsule.
    Other Name: Sugar Pill
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Active Comparator: DHEA + ERT
    Intervention: Drug: DHEA (Prasterone) + ERT (Aviane)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2011)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 11-18 years (potential subjects age 11-13 years must have a bone age x-ray (obtained within previous 6 months) that is 13 years or more advanced)
  • diagnosis of AN based on DSM-IV criteria
  • female gender
  • postmenarchal

Exclusion Criteria:

  • concomitant chronic diseases which affect bone health (e.g., cystic fibrosis, celiac disease)
  • use of medications known to affect bone metabolism during the last 3 months
  • use of depot medroxyprogesterone acetate during the last 12 months
  • current pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343771
Other Study ID Numbers  ICMJE 11-01-0634
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catherine M. Gordon, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine M Gordon, MD, MSc Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP