Clinical Trial Results:
The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women
Summary
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EudraCT number |
2020-002934-34 |
Trial protocol |
DK |
Global end of trial date |
01 Feb 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
24 May 2023
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First version publication date |
24 May 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2020-AKA
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04864509 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
Klinik for knogleskørhed, Anne Kristine Amstrup, anneamst@rm.dk
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Scientific contact |
Klinik for knogleskørhed, Anne Kristine Amstrup, anneamst@rm.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Feb 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Feb 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Feb 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Changes in gene expression in mesenchymal stem cells
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Protection of trial subjects |
At every visit the participants were asked whether or not they had experienced adverse event to the treatment.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 May 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 41
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Worldwide total number of subjects |
41
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EEA total number of subjects |
41
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were invited by letter. Recruitment period was from May to September 2021 | ||||||||||||||||||
Pre-assignment
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Screening details |
Participants responding positively to the invitation received a questionnaire regarding exclusion criteria. Those who did not fulfill the exclusions criteria received further information about the study. They were further invited to an interview at the study place. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall period trial
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | ||||||||||||||||||
Blinding implementation details |
Glostrup Pharmacy randomized the participants (using a computer) into blocks of 2,4, and 8 participants. The block-sizes were unknown to the investigators. The participants as well as the investigators were blinded to the study drug allocation
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Melatonin | ||||||||||||||||||
Arm description |
Nightly dose og 10mg melatonin | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
melatonin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg nightly
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Placebo | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg nightly
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Baseline characteristics reporting groups
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Reporting group title |
Overall period trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Melatonin
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Reporting group description |
Nightly dose og 10mg melatonin | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo |
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End point title |
Changes in mesenchymal stem cells | ||||||||||||
End point description |
data still being analyzed
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End point type |
Primary
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End point timeframe |
Changes after three months of treatment
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Statistical analysis title |
T-test | ||||||||||||
Comparison groups |
Melatonin v Placebo
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Number of subjects included in analysis |
29
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||
upper limit |
- | ||||||||||||
Variability estimate |
Standard deviation
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End point title |
Changes in 24H blood pressure | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Changes before and after three months of treatment
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No statistical analyses for this end point |
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End point title |
Changes in arterial stiffness | ||||||||||||
End point description |
data still being analyzed
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End point type |
Secondary
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End point timeframe |
Changes before and after three months of treatment
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No statistical analyses for this end point |
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End point title |
changes in biochemical parametres | ||||||||||||
End point description |
data still being analyzed
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End point type |
Secondary
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End point timeframe |
Changes before and after three months of treatment
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No statistical analyses for this end point |
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End point title |
Changes in BMD | ||||||||||||
End point description |
Data still being analyzed
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End point type |
Secondary
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End point timeframe |
Changes before and after three months of treatment
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No statistical analyses for this end point |
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End point title |
Changes in quality of sleep | ||||||||||||
End point description |
data still being analyzed
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End point type |
Secondary
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End point timeframe |
Changes before and after three months of treatment
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Period of reporting: june 2021- febuary 2022
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
x
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Reporting groups
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Reporting group title |
Melatonin
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |