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Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study

Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03292146
Enrollment
30
Registered
2017-09-25
Start date
2017-10-25
Completion date
2021-07-22
Last updated
2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Atypical Anorexia Nervosa, Bone Density, Bone Loss, Eating Disorder

Brief summary

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

Interventions

DRUGDenosumab 60 MG [Prolia]

Denosumab 60mg injection at baseline and 6 months

DRUGPlacebo Injection

Placebo Injection at baseline and 6 months

DRUGAlendronate 70Mg Tab

Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Sponsors

Amgen
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double blind

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Inclusion/

Exclusion criteria

Inclusion Criteria: * Female * Age 20-60 years, skeletally mature with closed epiphyses * Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria * BMD T-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) * Intraduterine hormonal-releasing system (IUS) * Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion) * Your male partner has had a vasectomy and testing shows there is no sperm in the semen * Dental check up within the past year

Design outcomes

Primary

MeasureTime frameDescription
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)12 months (Period 1)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).

Secondary

MeasureTime frame
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXABaseline to 24 months

Countries

United States

Participant flow

Recruitment details

Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0

Pre-assignment details

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

Participants by arm

ArmCount
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.
20
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
10
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
12 months to 24 monthsLost to Follow-up01
12 months to 24 monthsPersonal reasons10
12 months to 24 monthsPlanning pregnancy22
Baseline to 12 monthsRelocation10
Baseline to 12 monthsSeeking higher level of care for eating disorder10
Baseline to 12 monthsSeeking treatment for chronic fatigue syndrome01

Baseline characteristics

CharacteristicTotalDenosumab (0-12 months) followed by alendronate (12-24 months)Placebo (0-12 months) followed by alendronate (12-24 months)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants20 Participants10 Participants
Age, Continuous29.3 years
STANDARD_DEVIATION 7.5
29.2 years
STANDARD_DEVIATION 8
29.4 years
STANDARD_DEVIATION 6.8
Body mass index (BMI)18.7 kg / m^2
STANDARD_DEVIATION 1.9
19.0 kg / m^2
STANDARD_DEVIATION 1.7
18.0 kg / m^2
STANDARD_DEVIATION 2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants20 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Postero-anterior (PA) lumbar spine aBMD0.86 g/cm^2
STANDARD_DEVIATION 0.12
0.86 g/cm^2
STANDARD_DEVIATION 0.09
0.85 g/cm^2
STANDARD_DEVIATION 0.16
Postero-anterior (PA) lumbar spine areal bone mineral density (aBMD) Z-score-1.6 Z-score
STANDARD_DEVIATION 1.1
-1.6 Z-score
STANDARD_DEVIATION 0.9
-1.7 Z-score
STANDARD_DEVIATION 1.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
29 Participants19 Participants10 Participants
Region of Enrollment
United States
30 participants20 participants10 participants
Sex: Female, Male
Female
30 Participants20 Participants10 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 10
other
Total, other adverse events
6 / 203 / 10
serious
Total, serious adverse events
0 / 200 / 10

Outcome results

Primary

Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)

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).

Time frame: 12 months (Period 1)

Population: Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Denosumab (0-12 months) followed by alendronate (12-24 months)Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)0.90 g/cm^2Standard Error 0.03
Placebo (0-12 months) followed by alendronate (12-24 months)Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)0.87 g/cm^2Standard Error 0.04
p-value: 0.009Mixed Models Analysis
Secondary

Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

Time frame: Baseline to 24 months

Population: Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0

ArmMeasureValue (MEAN)Dispersion
Denosumab (0-12 months) followed by alendronate (12-24 months)Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA3.9 % changeStandard Deviation 4.3
Placebo (0-12 months) followed by alendronate (12-24 months)Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA5.8 % changeStandard Deviation 5.3
p-value: 0.41t-test, 2 sided
Secondary

Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

Time frame: 12 months to 24 months (Period 2)

Population: Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0

ArmMeasureValue (MEAN)Dispersion
Denosumab (0-12 months) followed by alendronate (12-24 months)Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA-2.0 % changeStandard Deviation 3.7
Placebo (0-12 months) followed by alendronate (12-24 months)Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA4.6 % changeStandard Deviation 3.2
p-value: 0.06Matched pairs
p-value: 0.01Matched pairs

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026