Trial · NCT01690000
Treatment of Osteopenia With Melatonin
NCT01690000, Not applicable, Completed, University of Aarhus; results first posted 2016-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Osteopenia With Melatonin. Trials, record NCT01690000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01690000
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Osteopenia With Melatonin
- NCT number
- NCT01690000
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 81 participants, actual
- Lead sponsor
- University of Aarhus
- Conditions
- Osteoporosis
- Interventions
- Melatonin
- First posted
- 2012-09-21
- Last updated
- 2016-05-06
- Results first posted
- 2016-05-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Bone Mineral Density (BMD) | baseline and end of study (after 12 months) | Effects of melatonin on BMD will be assessed through DXA-scans |
| Secondary | Changes in Calcium Homeostasis | baseline, after 3, 6, 9 months, and end of study (after 12 months) | Calcium homeostasis will be analyzed through blood and urines samples |
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 | Changes in Bone Mineral Density (BMD) | baseline and end of study (after 12 months) | percentage of change in BMD | MEAN | |
| SECONDARY | Changes in Calcium Homeostasis | baseline, after 3, 6, 9 months, and end of study (after 12 months) |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Bone Mineral Density (BMD) | Melatonin1+3 | -0.05 | Standard Error 3.07 | percentage of change in BMD | |
| Changes in Bone Mineral Density (BMD) | Placebo | -1.45 | Standard Error 2.81 | percentage of change in BMD |
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 | Melatonin1+3 | 40 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | Melatonin1+3 | 37 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Melatonin1+3 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events4
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 | Infection not assumed related to study medicine | Infections and infestations | Melatonin1+3 | 19 | 40 | 22 |
| other | Infection not assumed related to study medicine | Infections and infestations | Placebo | 17 | 41 | 21 |
| serious | Planned operation | Musculoskeletal and connective tissue disorders | Melatonin1+3 | 5 | 40 | 5 |
| serious | Planned operation | Musculoskeletal and connective tissue disorders | Placebo | 7 | 41 | 7 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melatonin1+3 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Melatonin1+3 | 19 | 40 |
| Total, other adverse events | Placebo | 17 | 41 |
| Total, serious adverse events | Melatonin1+3 | 5 | 40 |
| Total, serious adverse events | Placebo | 7 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26424587 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Melatonin1+3 vs Placebo: serious adverse events |
Source 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/NCT01690000
GET https://conductscience.org/api/trials/v1/NCT01690000/registered