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



Status:Recruiting
Conditions:Orthopedic, Orthopedic, Psychiatric, Psychiatric, Eating Disorder
Therapuetic Areas:Psychiatry / Psychology, Orthopedics / Podiatry
Healthy:No
Age Range:20 - 60
Updated:3/31/2019
Start Date:October 25, 2017
End Date:May 2020
Contact:Karen K Miller, MD
Email:KKMILLER@partners.org
Phone:617-726-3870

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Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to
investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators
hypothesize that 12 months of denosumab administration will result in an increase in bone
mineral density, decrease in markers of bone resorption and improvement in bone
microarchitecture in osteopenic women with anorexia nervosa compared with placebo.


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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-3870
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Boston, MA
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