Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
Amgen
Age
20–60
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
