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Help with Anorexia Study

Massachusetts General Hospital

The Neuroendocrine Unit at the Massachusetts General Hospital is conducting an important research study that focuses on the effects of anorexia nervosa on peak bone mass. Please review and pass along to any one you may know in the Massachusetts area that may also be interested in participating in this research study.

The young adult years are a very important time to build bones in order to help prevent future fractures. Two hormones that help build bones during this time are estrogen and insulin. These hormones increase and peak during the years of puberty, and contribute greatly to building bone. These two hormones are also extremely important for both bone formation and preservation. Low weight and/or nutritional restriction due to anorexia can lead to low levels of these two hormones. Girls and young women with anorexia are at an increased risk for low bone mineral density as well as fractures. We have previously shown that small replacement doses of estrogen help prevent further bone loss in girls with anorexia nervosa. However, bone density does not become normal, likely because of a persistent deficiency of other hormones such as insulin. This study will assess whether adding insulin to estrogen replacement is effective in further increasing and potentially normalizing bone density young women with anorexia nervosa.

The study involves:

· Coming to Massachusetts General Hospital for a visit to assess whether you or not you are eligible for the study. This consists of a medical and hormonal evaluation, as well as a bone density test. All of this would be performed at no cost to you.

· The results will be available to be shared and discussed with you, and if you wish, the results can also be shared with your doctor.

If you are eligible for the study and would like to participate, you will be asked to:

· Take a replacement dose of estrogen using a patch that sticks to your skin (which would be approximately the size of a postage stamp) and delivers estrogen that is absorbed through the skin.You will be asked to apply this patch twice a week.

· You will also be asked to take another hormone called progesterone for 10 days of every month,

· You will be asked to take calcium and vitamin D supplement.

· You will be randomized (assigned by chance, like the flip of a coin) to receive either replacement doses of IGF-1 replacement or placebo (no active medication).

· You will be asked to take these medications for twelve months.

· There will be 11 total study visits (10 visits, including the screening visit to assess eligibility, take place during the initial twelve months and an additional visit is scheduled one year later). Some of these visits can be completed with a local physician if travel to Massachusetts General Hospital is difficult. Bone density tests will be performed at the start, middle, and end of the trial.

· A stipend is not provided for the screening visit; however, you will receive $75 per study visit (after the screening visit) for a total of $750 at completion of the study. The cost of parking/public transportation is covered for each visit to Massachusetts General Hospital.

If you are interested in learning more about the study, please contact:   Study Research Coordinator, Hannah Clarke,  (617) 724-6046, hclarke@partners.org   Study MD, Dr. Madhusmita Misra  (617) 724-5602