Trial Outcomes & Findings for Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (NCT NCT04779216)
NCT ID: NCT04779216
Last Updated: 2025-12-16
Results Overview
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Baseline to 12 Months
Results posted on
2025-12-16
Participant Flow
Randomized, double-blind, placebo-controlled trial. 30 subjects randomized in a 2:1 ratio to romosozumab followed by zoledronic acid or placebo followed by zoledronic acid
Participant milestones
| Measure |
Active Romosozumab 210mg Injection
Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Placebo
Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Active Romosozumab 210mg Injection
Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Placebo
Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One subject's BMI was adjusted for amputation.
Baseline characteristics by cohort
| Measure |
Active Romosozumab 210mg Injection
n=20 Participants
Romosozumab 210mg Injection monthly for 12 months
A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Placebo
n=10 Participants
Placebo injection monthly for 12 months.
A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 13 • n=6 Participants
|
27 years
STANDARD_DEVIATION 6 • n=5 Participants
|
31 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=6 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=6 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Postero-anterior (PA) lumbar spine bone mineral density (BMD) Mean (Standard Deviation)
|
0.84 g/cm^2
STANDARD_DEVIATION 0.092 • n=6 Participants
|
0.81 g/cm^2
STANDARD_DEVIATION 0.065 • n=5 Participants
|
0.83 g/cm^2
STANDARD_DEVIATION 0.084 • n=5 Participants
|
|
Postero-anterior (PA) lumbar spine BMD Z-score
|
-1.60 Z-score
STANDARD_DEVIATION 0.88 • n=6 Participants
|
-2.06 Z-score
STANDARD_DEVIATION 0.60 • n=5 Participants
|
-1.75 Z-score
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Body mass index (BMI)
|
19.3 kg/m^2
STANDARD_DEVIATION 2.2 • n=6 Participants • One subject's BMI was adjusted for amputation.
|
18.8 kg/m^2
STANDARD_DEVIATION 1.2 • n=5 Participants • One subject's BMI was adjusted for amputation.
|
19.1 kg/m^2
STANDARD_DEVIATION 1.9 • n=5 Participants • One subject's BMI was adjusted for amputation.
|
PRIMARY outcome
Timeframe: Baseline to 12 MonthsPopulation: Women, age 20-60 years, with anorexia nervosa
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Active Romosozumab 210mg Injection
n=20 Participants
Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Placebo
n=10 Participants
Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
|---|---|---|
|
Percent Change From Baseline to 12 Months in Postero-anterior Lumbar Spine Bone Mineral Density by Dual Energy X-ray Absorptiometry (DXA).
|
12.4 % change
Standard Deviation 4.2
|
-0.3 % change
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPercent 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.
Outcome measures
Outcome data not reported
Adverse Events
Active Romosozumab 210mg Injection
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Romosozumab 210mg Injection
n=20 participants at risk
Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
Placebo
n=10 participants at risk
Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg at the 12-month visit.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Irritation/soreness/swelling at injection sites
|
40.0%
8/20 • Baseline to 12 months.
|
10.0%
1/10 • Baseline to 12 months.
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • Baseline to 12 months.
|
10.0%
1/10 • Baseline to 12 months.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
General disorders
Headache
|
10.0%
2/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
Reproductive system and breast disorders
Intermittent galactorrhea
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Baseline to 12 months.
|
0.00%
0/10 • Baseline to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place