Trial · NCT03292146
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
NCT03292146, Phase 3, Completed, Massachusetts General Hospital; results first posted 2022-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study. Trials, record NCT03292146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
- NCT number
- NCT03292146
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Bone Density, Bone Loss, Anorexia Nervosa, Eating Disorder, Atypical Anorexia Nervosa
- Interventions
- Denosumab 60 MG [Prolia], Placebo Injection, Alendronate 70Mg Tab
- First posted
- 2017-09-25
- Last updated
- 2025-11-04
- Results first posted
- 2022-10-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Baseline to 24 months | |
| Secondary | Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | 12 months to 24 months (Period 2) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA) | 12 months (Period 1) | Women, age 20-60 years, with anorexia nervosa or atypical anorexia nervosa and BMD T-score \< -1.0 | g/cm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Baseline to 24 months | Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0 | % change | MEAN |
| SECONDARY | Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | 12 months to 24 months (Period 2) | Women ages 20-60 with anorexia nervosa/atypical anorexia nervosa and BMD T-score \< -1.0 | % change | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA) | Denosumab (0-12 months) followed by alendronate (12-24 months) | 0.90 | Standard Error 0.03 | g/cm^2 | |
| Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA) | Placebo (0-12 months) followed by alendronate (12-24 months) | 0.87 | Standard Error 0.04 | g/cm^2 | |
| Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Denosumab (0-12 months) followed by alendronate (12-24 months) | 3.9 | Standard Deviation 4.3 | % change | |
| Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Placebo (0-12 months) followed by alendronate (12-24 months) | 5.8 | Standard Deviation 5.3 | % change | |
| Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Denosumab (0-12 months) followed by alendronate (12-24 months) | -2.0 | Standard Deviation 3.7 | % change | |
| Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA | Placebo (0-12 months) followed by alendronate (12-24 months) | 4.6 | Standard Deviation 3.2 | % change |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline to 12 months | STARTED | Denosumab (0-12 months) followed by alendronate (12-24 months) | 20 | |
| Baseline to 12 months | STARTED | Placebo (0-12 months) followed by alendronate (12-24 months) | 10 | |
| Baseline to 12 months | COMPLETED | Denosumab (0-12 months) followed by alendronate (12-24 months) | 18 | |
| Baseline to 12 months | COMPLETED | Placebo (0-12 months) followed by alendronate (12-24 months) | 9 | |
| Baseline to 12 months | NOT COMPLETED | Denosumab (0-12 months) followed by alendronate (12-24 months) | 2 | |
| Baseline to 12 months | NOT COMPLETED | Placebo (0-12 months) followed by alendronate (12-24 months) | 1 | |
| 12 months to 24 months | STARTED | Denosumab (0-12 months) followed by alendronate (12-24 months) | 18 | |
| 12 months to 24 months | STARTED | Placebo (0-12 months) followed by alendronate (12-24 months) | 9 | |
| 12 months to 24 months | COMPLETED | Denosumab (0-12 months) followed by alendronate (12-24 months) | 15 | |
| 12 months to 24 months | COMPLETED | Placebo (0-12 months) followed by alendronate (12-24 months) | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
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 | Events |
|---|---|---|---|---|---|---|
| other | constipation | Gastrointestinal disorders | Denosumab (0-12 months) followed by alendronate (12-24 months) | 3 | 20 | 4 |
| other | constipation | Gastrointestinal disorders | Placebo (0-12 months) followed by alendronate (12-24 months) | 0 | 10 | 0 |
| other | COVID-19 | Infections and infestations | Denosumab (0-12 months) followed by alendronate (12-24 months) | 1 | 20 | 1 |
| other | COVID-19 | Infections and infestations | Placebo (0-12 months) followed by alendronate (12-24 months) | 1 | 10 | 1 |
| other | nausea/stomach pain/bloating | Gastrointestinal disorders | Denosumab (0-12 months) followed by alendronate (12-24 months) | 1 | 20 | 2 |
| other | nausea/stomach pain/bloating | Gastrointestinal disorders | Placebo (0-12 months) followed by alendronate (12-24 months) | 0 | 10 | 0 |
| other | bone fracture | Injury, poisoning and procedural complications | Denosumab (0-12 months) followed by alendronate (12-24 months) | 1 | 20 | 1 |
| other | bone fracture | Injury, poisoning and procedural complications | Placebo (0-12 months) followed by alendronate (12-24 months) | 1 | 10 | 1 |
| other | Keratitis | Infections and infestations | Denosumab (0-12 months) followed by alendronate (12-24 months) | 1 | 20 | 1 |
| other | Keratitis | Infections and infestations | Placebo (0-12 months) followed by alendronate (12-24 months) | 0 | 10 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Denosumab (0-12 months) followed by alendronate (12-24 months) | 0 | 20 |
| Total, all-cause mortality | Placebo (0-12 months) followed by alendronate (12-24 months) | 0 | 10 |
| Total, other adverse events | Denosumab (0-12 months) followed by alendronate (12-24 months) | 6 | 20 |
| Total, other adverse events | Placebo (0-12 months) followed by alendronate (12-24 months) | 3 | 10 |
| Total, serious adverse events | Denosumab (0-12 months) followed by alendronate (12-24 months) | 0 | 20 |
| Total, serious adverse events | Placebo (0-12 months) followed by alendronate (12-24 months) | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Denosumab (0-12 months) followed by alendronate (12-24 months) vs Placebo (0-12 months) followed by alendronate (12-24 months): deaths from any cause | Trial comparisons |
| Denosumab (0-12 months) followed by alendronate (12-24 months) vs Placebo (0-12 months) followed by alendronate (12-24 months): 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.
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/NCT03292146
GET https://conductscience.org/api/trials/v1/NCT03292146/registered