Effects of Anorexia Nervosa on Bone Mass in Adolescents

This study has been completed.
Sponsor:
Collaborators:
The Hospital for Sick Children
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00088153
First received: July 20, 2004
Last updated: October 6, 2011
Last verified: September 2011
Results First Received: July 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anorexia Nervosa
Interventions: Drug: Physiologic Estrogen/progesterone
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Period of recruitment: 2003-2009. Location: Massachusetts General Hospital (Boston) and Hospital for Sick Children (Toronto).

We screened 150 girls with anorexia nervosa (AN) (110 at MGH and 40 at SickKids) and 88 normal-weight controls 12-18 years. Following the screen, 110 AN and 40 controls were enrolled for the prospective study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Reasons for enrolled participants being excluded from the trial before assignment to groups primarily included identification of exclusion criteria, loss of interest on the part of the participant, and loss to follow-up.

Reporting Groups
  Description
Physiologic Estrogen Replacement

Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).

Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study

Placebo Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills

Participant Flow:   Overall Study
    Physiologic Estrogen Replacement     Placebo  
STARTED     55     55  
COMPLETED     31     30  
NOT COMPLETED     24     25  
Physician Decision                 3                 3  
Withdrawal by Subject                 10                 10  
Lost to Follow-up                 11                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Physiologic Estrogen Replacement

Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).

Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study

Placebo Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
Total Total of all reporting groups

Baseline Measures
    Physiologic Estrogen Replacement     Placebo     Total  
Number of Participants  
[units: participants]
  55     55     110  
Age  
[units: participants]
     
<=18 years     55     55     110  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  16.6  ± 1.6     16.3  ± 1.6     16.5  ± 0.2  
Gender  
[units: participants]
     
Female     55     55     110  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     55     55     110  



  Outcome Measures
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1.  Primary:   Percent Change in Spine Bone Density Over the Study Duration (18 Months)   [ Time Frame: Baseline and 18 months ]

2.  Primary:   Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)   [ Time Frame: Baseline and 18 months ]

3.  Secondary:   Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)   [ Time Frame: Baseline and 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anne Klibanski
Organization: Massachusetts General Hospital
phone: 617-726-3870
e-mail: aklibanski@partners.org


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00088153     History of Changes
Other Study ID Numbers: DK062249, R01DK062249
Study First Received: July 20, 2004
Results First Received: July 6, 2011
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration