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Could a bone drug help women with anorexia? new study investigates

NCT ID NCT04779216

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether romosozumab, a drug that builds bone, can improve bone density in women with anorexia nervosa. Thirty women received either romosozumab or a placebo for 12 months, followed by a single dose of zoledronic acid. The goal was to see if bone density and structure improved, offering a potential way to prevent fractures 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
romosozumab (a bone-building drug) and zoledronic acid (a bone-strengthening drug)
What this could lead to
If successful, this could point toward a treatment to improve bone density and reduce fracture risk in women with anorexia nervosa.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to everyone. The long-term benefits and risks are still uncertain.

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

30 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2025

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

20 to 60 years

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female * Age 20-60 years, skeletally mature with closed epiphyses * Body mass index (BMI) ≥ 16.5 kg/m2 * Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria * BMD Z-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); Intrauterine hormonal-releasing system (IUS); Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion); Woman's 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: * Hospitalization within 3 months of baseline study visit, including inpatient eating disorder treatment facility; participating in a residential eating disorder treatment program within 3 months of study participation is permitted * Myocardial infarction or stroke within 1 year preceding enrollment * History of hypertension or use of anti-hypertensive medications within the past 6 months * Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure * 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 25-OH vitamin D level \<30 ng/mL * Serum potassium \<3.0 meq/L * Serum magnesium \<1.5 meq/L * Serum ALT \>3 times upper limit of normal * eGFR of less than 30 ml/min * LDL \> 190 mg/dL * Hypocalcemia * Diabetes mellitus * Active substance abuse, including alcohol * Current smoker * 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 sensitivity to any of the products or components of the medication to be administered * Sensitivity to calcium or vitamin D supplements * Pregnant, planning to become pregnant within 12 months after the end of treatment and/or breastfeeding * Hypersensitivity to any component of zoledronic acid

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Conditions

The condition(s) this trial relates to.

anorexia nervosa Bone Diseases, Metabolic eating disorder Feeding and Eating Disorders osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.