Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study

Inclusion/Exclusion Criteria:

Inclusion Criteria:

- Female

- Age 20-60 years, skeletally mature with closed epiphyses

- Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria

- BMD T-score < -1.0

- Normal serum 25-OH vitamin D (>30 ng/mL) and calcium levels

- For women of reproductive age, agree to use an effective contraceptive method. Highly
effective methods of birth control include:

- Combined (estrogen and progestogen) hormonal methods (pills, vaginal ring, or
skin patch)

- Intrauterine device (IUD)

- Intraduterine hormonal-releasing system (IUS)

- Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion)

- Your male partner has had a vasectomy and testing shows there is no sperm in the
semen

- Dental check up within the past year

Exclusion Criteria:

- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's
or renal failure

- Subjects with a known esophageal disease cannot participate in the alendronate
extension study

- Any medication known to affect bone metabolism within 3 months of the study, excluding
oral contraceptives or other forms of estrogen administration. Bisphosphonates must
have been discontinued for at least one year before participation

- Immunodeficiency or taking immunosuppressive therapy

- Serum potassium <3.0 meq/L

- Serum ALT >3 times upper limit of normal

- eGFR of less than 30 ml/min

- Hypocalcemia

- Diabetes mellitus

- Active substance abuse, including alcohol

- History of malignancy

- Paget disease of bone

- Osteomalacia

- Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental
procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months),
poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of
corticosteroids.

- Planned invasive dental procedure over the next 24 months.

- Known senstivity to any of the products or components to be administered during dosing
or known sensitivity to mammalian cell derived drug products

- Sensitivity to calcium or vitamin D supplements

- Pregnant, planning to become pregnant with 7 months after the end of treatment and/or
breastfeeding