Bone Density, LowPhase 3NCT04779216
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
A Phase 3 study testing Romosozumab Prefilled Syringe and Zoledronic acid 5 mg in people with Bone Density, Low and Bone Loss, run by Karen Klahr Miller, MD at 1 site in United States.
Trial summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Bone Density, Low, Bone Loss, Anorexia Nervosa
- What is being tested?
- Romosozumab Prefilled Syringe and Zoledronic acid 5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 17 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effects of Romosozumab on Bone 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 romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
In Phase 2, participants will receive a single infusion of open-label zoledronic acid (an intravenous bisphosphonate) 5 mg after the initial 12-month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by a single intravenous infusion of open-label zoledronic acid will result in a greater increase in BMD compared to 12 months of placebo followed by a single intravenous infusion of open-label zoledronic acid. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by a single intravenous infusion of zoledronic acid, the investigators hypothesize BMD will be maintained between 12 and 24 months following administration of zoledronic acid.
- Conditions
- Bone Density, Low, Bone Loss, Anorexia Nervosa, Eating Disorders
- Being tested
- Romosozumab Prefilled Syringe, Placebo, Zoledronic acid 5 mg
- Medical subject headings
- Bone Diseases, Metabolic, Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romosozumab Prefilled SyringeDrug
Romosozumab 210mg Injection monthly for 12 months
PlaceboDrug
Placebo Injection monthly for 12 months
Zoledronic acid 5 mgDrug
Also called Zoledronate, Reclast
A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab or placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Romosozumab 210mg Injection | Experimental | Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab. Receives: Drug: Romosozumab Prefilled Syringe; Drug: Zoledronic acid 5 mg |
| Placebo | Placebo comparator | Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of placebo. Receives: Drug: Placebo; Drug: Zoledronic acid 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
Measured: Baseline to 12 Months
Secondary outcomes (1)
Percent Change From Baseline to 24 Months in Postero-anterior Lumbar Spine BMD.
Percent change from baseline to 24 months in postero-anterior lumbar spine bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA). This is a secondary endpoint at 24 months (study completion). The 24-month completion date was 11/17/2025. The 24-month results will be reported in November 2026.
Measured: Baseline to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start20 Sep 2021
- Primary completion24 Oct 2024
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Density, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Klahr Miller, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779216
- Sponsor's protocol ID
- 2020P000329
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2021
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Romosozumab on Bone Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
- ClinicalTrials.gov ID
- NCT04779216
- Acronym / sponsor ID
- 2020P000329
- Conditions
- Bone Density, Low, Bone Loss, Anorexia Nervosa, Eating Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karen Klahr Miller, MDUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
In Phase 2, participants will receive a single infusion of open-label zoledronic acid (an intravenous bisphosphonate) 5 mg after the initial 12-month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by a single intravenous infusion of open-label zoledronic acid will result in a greater increase in BMD compared to 12 months of placebo followed by a single intravenous infusion of open-label zoledronic acid. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by a single intravenous infusion of zoledronic acid, the investigators hypothesize BMD will be maintained between 12 and 24 months following administration of zoledronic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Romosozumab 210mg Injection | Experimental | Drug: Romosozumab Prefilled Syringe, Drug: Zoledronic acid 5 mgRomosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Zoledronic acid 5 mgPlacebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of placebo. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Romosozumab Prefilled SyringeRomosozumab 210mg Injection monthly for 12 months | Drug | Active Romosozumab 210mg Injection |
| PlaceboPlacebo Injection monthly for 12 months | Drug | Placebo |
| Zoledronic acid 5 mgAlso: Zoledronate, ReclastA single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab or placebo | Drug | Active Romosozumab 210mg Injection, Placebo |
Primary outcome
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).
Time frame: Baseline to 12 Months
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
1 secondary outcome
Percent Change From Baseline to 24 Months in Postero-anterior Lumbar Spine BMD.
Time frame: Baseline to 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romosozumab Prefilled Syringe and Zoledronic acid 5 mg in people with Bone Density, Low and Bone Loss, run by Karen Klahr Miller, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA). (time frame: Baseline to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.