Trial · NCT04779216

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

NCT04779216, Phase 3, Completed, Karen Klahr Miller, MD; results first posted 2025-12-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa. Trials, record NCT04779216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04779216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
NCT number: NCT04779216
Status: Completed
Phases: Phase 3
Enrollment: 30 participants, actual
Lead sponsor: Karen Klahr Miller, MD
Conditions: Bone Density, Low, Bone Loss, Anorexia Nervosa, Eating Disorders
Interventions: Romosozumab Prefilled Syringe, Placebo, Zoledronic acid 5 mg
First posted: 2021-03-03
Last updated: 2025-12-16
Results first posted: 2025-12-16

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).	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).
Secondary	Percent Change From Baseline to 24 Months in Postero-anterior Lumbar Spine BMD.	Baseline to 24 Months	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).	Baseline to 12 Months	Women, age 20-60 years, with anorexia nervosa	% change	MEAN
SECONDARY	Percent Change From Baseline to 24 Months in Postero-anterior Lumbar Spine BMD.	Baseline to 24 Months

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).	Active Romosozumab 210mg Injection		12.4	Standard Deviation 4.2	% change
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).	Placebo		-0.3	Standard Deviation 3.7	% change

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Romosozumab 210mg Injection	20
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	Active Romosozumab 210mg Injection	18
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	Active Romosozumab 210mg Injection	2
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Irritation/soreness/swelling at injection sites	Skin and subcutaneous tissue disorders	Active Romosozumab 210mg Injection	8	20
other	Irritation/soreness/swelling at injection sites	Skin and subcutaneous tissue disorders	Placebo	1	10
other	COVID-19	Infections and infestations	Active Romosozumab 210mg Injection	1	20
other	COVID-19	Infections and infestations	Placebo	1	10
other	Nausea	Gastrointestinal disorders	Active Romosozumab 210mg Injection	1	20
other	Nausea	Gastrointestinal disorders	Placebo	0	10
other	Headache	General disorders	Active Romosozumab 210mg Injection	2	20
other	Headache	General disorders	Placebo	0	10
other	Vaginal Discharge	Reproductive system and breast disorders	Active Romosozumab 210mg Injection	1	20
other	Vaginal Discharge	Reproductive system and breast disorders	Placebo	0	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Romosozumab 210mg Injection	0	20
Total, all-cause mortality	Placebo	0	10
Total, other adverse events	Active Romosozumab 210mg Injection	12	20
Total, other adverse events	Placebo	2	10
Total, serious adverse events	Active Romosozumab 210mg Injection	0	20
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39703866	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active Romosozumab 210mg Injection vs Placebo: deaths from any cause	Trial comparisons
Active Romosozumab 210mg Injection vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04779216

GET https://conductscience.org/api/trials/v1/NCT04779216/registered

API reference For AI assistants