Trial Outcomes & Findings for Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (NCT NCT03292146)
NCT ID: NCT03292146
Last Updated: 2025-11-04
Results Overview
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
12 months (Period 1)
Results posted on
2025-11-04
Participant Flow
Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0
Randomized, double-blind, placebo-controlled trial. 30 subjects randomized in a 2:1 ratio to denosumab followed by alendronate or placebo followed by alendronate groups
Participant milestones
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Baseline to 12 months
STARTED
|
20
|
10
|
|
Baseline to 12 months
COMPLETED
|
18
|
9
|
|
Baseline to 12 months
NOT COMPLETED
|
2
|
1
|
|
12 months to 24 months
STARTED
|
18
|
9
|
|
12 months to 24 months
COMPLETED
|
15
|
6
|
|
12 months to 24 months
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Baseline to 12 months
Relocation
|
1
|
0
|
|
Baseline to 12 months
Seeking higher level of care for eating disorder
|
1
|
0
|
|
Baseline to 12 months
Seeking treatment for chronic fatigue syndrome
|
0
|
1
|
|
12 months to 24 months
Planning pregnancy
|
2
|
2
|
|
12 months to 24 months
Personal reasons
|
1
|
0
|
|
12 months to 24 months
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Baseline characteristics by cohort
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
n=20 Participants
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
n=10 Participants
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
30 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 8.0 • n=15 Participants
|
29.4 years
STANDARD_DEVIATION 6.8 • n=161 Participants
|
29.3 years
STANDARD_DEVIATION 7.5 • n=100 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
30 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
30 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
29 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=15 Participants
|
10 participants
n=161 Participants
|
30 participants
n=100 Participants
|
|
Body mass index (BMI)
|
19.0 kg / m^2
STANDARD_DEVIATION 1.7 • n=15 Participants
|
18.0 kg / m^2
STANDARD_DEVIATION 2.0 • n=161 Participants
|
18.7 kg / m^2
STANDARD_DEVIATION 1.9 • n=100 Participants
|
|
Postero-anterior (PA) lumbar spine areal bone mineral density (aBMD) Z-score
|
-1.6 Z-score
STANDARD_DEVIATION 0.9 • n=15 Participants
|
-1.7 Z-score
STANDARD_DEVIATION 1.4 • n=161 Participants
|
-1.6 Z-score
STANDARD_DEVIATION 1.1 • n=100 Participants
|
|
Postero-anterior (PA) lumbar spine aBMD
|
0.86 g/cm^2
STANDARD_DEVIATION 0.09 • n=15 Participants
|
0.85 g/cm^2
STANDARD_DEVIATION 0.16 • n=161 Participants
|
0.86 g/cm^2
STANDARD_DEVIATION 0.12 • n=100 Participants
|
PRIMARY outcome
Timeframe: 12 months (Period 1)Population: Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
Outcome measures
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
n=20 Participants
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
n=10 Participants
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
|
0.90 g/cm^2
Standard Error 0.03
|
0.87 g/cm^2
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsPopulation: Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0
Outcome measures
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
n=20 Participants
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
n=10 Participants
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
|
3.9 % change
Standard Deviation 4.3
|
5.8 % change
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 12 months to 24 months (Period 2)Population: Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0
Outcome measures
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
n=20 Participants
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
n=10 Participants
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
|
-2.0 % change
Standard Deviation 3.7
|
4.6 % change
Standard Deviation 3.2
|
Adverse Events
Denosumab (0-12 months) followed by alendronate (12-24 months)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (0-12 months) followed by alendronate (12-24 months)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Denosumab (0-12 months) followed by alendronate (12-24 months)
n=20 participants at risk
Denosumab 60 mg SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
Placebo (0-12 months) followed by alendronate (12-24 months)
n=10 participants at risk
Placebo SQ injections q6 months for 12 months followed by alendronate 70 mg PO weekly for 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Gallbladder biliary dyskinesia
|
0.00%
0/20 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
10.0%
1/10 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Infections and infestations
C. difficile
|
5.0%
1/20 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
0.00%
0/10 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Injury, poisoning and procedural complications
Disc degeneration and herniation
|
5.0%
1/20 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
0.00%
0/10 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Gastrointestinal disorders
constipation
|
15.0%
3/20 • Number of events 4 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
0.00%
0/10 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
10.0%
1/10 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Gastrointestinal disorders
nausea/stomach pain/bloating
|
5.0%
1/20 • Number of events 2 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
0.00%
0/10 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Injury, poisoning and procedural complications
bone fracture
|
5.0%
1/20 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
10.0%
1/10 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
|
Infections and infestations
Keratitis
|
5.0%
1/20 • Number of events 1 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
0.00%
0/10 • Baseline to 24 months
Serious adverse events reported to the IRB immediately upon the PI becoming aware.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place