Effects of Anorexia Nervosa on Bone Mass in Adolescents
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in
      adolescents. Whether administration of estrogen, a normal hormone present during puberty, can
      help maintain bone development in girls with anorexia nervosa will be determined.
    

Detailed description: 
      Adolescence is a critical time for bone mineral accretion as between 60-90% of peak bone mass
      is established during this period, and peak bone mass is a major determinant of bone density
      and osteoporosis risk during adulthood. Anorexia nervosa (AN) is the third most common
      chronic illness among adolescent girls, with a prevalence of 0.2-1.0%. Therefore, AN occurs
      at a time during which patients are the most vulnerable to disruption of bone mineral
      accretion. Osteopenia is a major co-morbid complication of AN in 50-75% of female adolescents
      and adult women with this eating disorder. Women with the onset of the disorder during
      adolescence have more severe osteopenia than women with onset during adulthood. Little is
      known about the pathogenesis of osteopenia in this adolescent population and there are no
      established therapies. Improved understanding of bone mineral metabolism and factors which
      predict recovery of bone mineral accretion are critical in the development of therapeutic
      strategies to preserve and maximize bone mass in girls with the onset of AN during
      adolescence. Estrogen is known to be a critical factor in the development of peak bone mass.
      Although AN is associated with profound estrogen deficiency, there are no controlled studies
      investigating the effects of estrogen administration in this population.

      This research proposal will address critical unanswered questions regarding bone
      abnormalities in adolescents with anorexia nervosa. Defining changes in bone formation with
      weight recuperation and hormonal variables would provide insight into the factors essential
      for bone mineral accretion during adolescence, as well as those that predict recovery.
      Determination of dose-dependent estrogen effects in this population will be key in targeting
      interventions during the time of active disease, with the long-term goal of preserving peak
      bone mass accretion in this vulnerable group of patients. Data obtained from women with
      post-menopausal osteoporosis or from women with AN cannot be extrapolated to adolescent
      patients who are in an active period of bone growth and mineralization as well as remodeling.
      Given the increasing prevalence of AN and its profound consequences on bone health, these
      studies will provide much needed data to enable treatment strategies for this severe
      co-morbid disease.
    

Intervention name(s): Physiologic Estrogen/progesterone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month; Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month
Other intervention name(s): Bone age >=15: Vivelle Dot patch with cyclic Provera
Intervention MeSH terms: Progesterone; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Amenorrhea; Bone Mass; Growth hormone