Can a bone drug help women with anorexia? small study hints at hope
NCT ID NCT03292146
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether denosumab, a drug used for osteoporosis, can improve bone density in women with anorexia nervosa. Thirty women received either denosumab or placebo injections over 12 months, with an optional year of alendronate. The goal was to see if bone density and structure improved, offering a potential new option for bone loss in this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Denosumab (Prolia) injection
- What this could lead to
- If it works, this could point toward a treatment for bone loss in women with anorexia nervosa, potentially reducing fracture risk.
- What could go wrong
- This is a small pilot study with only 30 participants, so results may not apply to everyone. The treatment also requires ongoing monitoring and may have side effects like infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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30 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Jul 2021
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 60 years
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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