Trial · NCT01301183
Effects of Anorexia Nervosa on Peak Bone Mass
NCT01301183, Phase 3, Completed, Massachusetts General Hospital; results first posted 2021-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Anorexia Nervosa on Peak Bone Mass. Trials, record NCT01301183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01301183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Anorexia Nervosa on Peak Bone Mass
- NCT number
- NCT01301183
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Anorexia Nervosa
- Interventions
- RhIGF-1 with transdermal 17-beta estradiol, Placebo and transdermal 17-beta estradiol
- First posted
- 2011-02-23
- Last updated
- 2021-07-13
- Results first posted
- 2021-07-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bone Density Over a 12-month Period | 12 months | Change in lumbar spine BMD z-score over 12 months as assessed by dual energy x-ray absorptiometry (DXA) The z-score indicates the number of standard deviations that BMD is away from the mean for age, sex and race. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher values. A positive change in z-scores indicates a favorable outcome whereas a negative change in z-scores indicates an unfavorable outcome. |
| Secondary | Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period | 12 months | Change in trabecular number at the ultradistal radius over 12 months as assessed by high resolution peripheral quantitative computed tomography (HRpQCT) |
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 | Change in Bone Density Over a 12-month Period | 12 months | score on a scale | MEDIAN | |
| SECONDARY | Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period | 12 months | 1/mm | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bone Density Over a 12-month Period | Rh IGF-1 + Transdermal Estradiol | 0.045 | Inter-Quartile Range -0.083 to 0.174 | score on a scale | |
| Change in Bone Density Over a 12-month Period | Placebo + Transdermal Estradiol | 0.280 | Inter-Quartile Range 0.085 to 0.475 | score on a scale | |
| Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period | Rh IGF-1 + Transdermal Estradiol | -0.10 | Inter-Quartile Range -0.18 to -0.02 | 1/mm | |
| Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period | Placebo + Transdermal Estradiol | -0.02 | Inter-Quartile Range -0.12 to 0.07 | 1/mm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rh IGF-1 + Transdermal Estradiol | 38 | |
| Overall Study | STARTED | Placebo + Transdermal Estradiol | 37 | |
| Overall Study | COMPLETED | Rh IGF-1 + Transdermal Estradiol | 12 | |
| Overall Study | COMPLETED | Placebo + Transdermal Estradiol | 21 | |
| Overall Study | NOT COMPLETED | Rh IGF-1 + Transdermal Estradiol | 26 | |
| Overall Study | NOT COMPLETED | Placebo + Transdermal Estradiol | 16 |
Source ClinicalTrials.gov
Adverse events24
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 | Rash at injection site | Skin and subcutaneous tissue disorders | Rh IGF-1 + Transdermal Estradiol | 2 | 38 | |
| other | Rash at injection site | Skin and subcutaneous tissue disorders | Placebo + Transdermal Estradiol | 0 | 37 | |
| other | Irritation at patch site | Skin and subcutaneous tissue disorders | Rh IGF-1 + Transdermal Estradiol | 1 | 38 | |
| other | Irritation at patch site | Skin and subcutaneous tissue disorders | Placebo + Transdermal Estradiol | 2 | 37 | |
| other | Irregular menses | Reproductive system and breast disorders | Rh IGF-1 + Transdermal Estradiol | 0 | 38 | |
| other | Irregular menses | Reproductive system and breast disorders | Placebo + Transdermal Estradiol | 3 | 37 | |
| other | Breast tenderness | Reproductive system and breast disorders | Rh IGF-1 + Transdermal Estradiol | 0 | 38 | |
| other | Breast tenderness | Reproductive system and breast disorders | Placebo + Transdermal Estradiol | 2 | 37 | |
| other | Vasovagal with venipuncture | Vascular disorders | Rh IGF-1 + Transdermal Estradiol | 1 | 38 | |
| other | Vasovagal with venipuncture | Vascular disorders | Placebo + Transdermal Estradiol | 3 | 37 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rh IGF-1 + Transdermal Estradiol | 0 | 38 |
| Total, all-cause mortality | Placebo + Transdermal Estradiol | 0 | 37 |
| Total, other adverse events | Rh IGF-1 + Transdermal Estradiol | 8 | 38 |
| Total, other adverse events | Placebo + Transdermal Estradiol | 19 | 37 |
| Total, serious adverse events | Rh IGF-1 + Transdermal Estradiol | 7 | 38 |
| Total, serious adverse events | Placebo + Transdermal Estradiol | 12 | 37 |
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 |
|---|---|
| Rh IGF-1 + Transdermal Estradiol vs Placebo + Transdermal Estradiol: deaths from any cause | Trial comparisons |
| Rh IGF-1 + Transdermal Estradiol vs Placebo + Transdermal Estradiol: 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/NCT01301183
GET https://conductscience.org/api/trials/v1/NCT01301183/events?page=2