Trial Outcomes & Findings for Treatment of Osteopenia With Melatonin (NCT NCT01690000)
NCT ID: NCT01690000
Last Updated: 2016-05-06
Results Overview
Effects of melatonin on BMD will be assessed through DXA-scans
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
baseline and end of study (after 12 months)
Results posted on
2016-05-06
Participant Flow
We recruited 81 postmenopausal women with osteopenia to receive either melatonin (n=40) (1 or 3 mg) or similar placebo (n=41) nightly for 12 months. In addition, all women received a daily supplementation with 800mg calcium and 20ug D3
A total of 202 women were invited to participate. 81 were included in the study
Participant milestones
| Measure |
Melatonin1+3
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
Placebo
Identical placebo given nightly for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Osteopenia With Melatonin
Baseline characteristics by cohort
| Measure |
Melatonin1+3
n=40 Participants
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
Placebo
n=41 Participants
Identical placebo given nightly for 12 months
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and end of study (after 12 months)Effects of melatonin on BMD will be assessed through DXA-scans
Outcome measures
| Measure |
Melatonin1+3
n=39 Participants
1+3 mg melatonin nightly
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
Placebo
n=37 Participants
Identical placebo given nightly
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
|---|---|---|
|
Changes in Bone Mineral Density (BMD)
|
-0.05 percentage of change in BMD
Standard Error 3.07
|
-1.45 percentage of change in BMD
Standard Error 2.81
|
SECONDARY outcome
Timeframe: baseline, after 3, 6, 9 months, and end of study (after 12 months)Calcium homeostasis will be analyzed through blood and urines samples
Outcome measures
Outcome data not reported
Adverse Events
Melatonin1+3
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melatonin1+3
n=40 participants at risk
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
Placebo
n=41 participants at risk
Identical placebo given nightly for 12 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Planned operation
|
12.5%
5/40 • Number of events 5 • 12 months (entire study period)
|
17.1%
7/41 • Number of events 7 • 12 months (entire study period)
|
Other adverse events
| Measure |
Melatonin1+3
n=40 participants at risk
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
|
Placebo
n=41 participants at risk
Identical placebo given nightly for 12 months
|
|---|---|---|
|
Infections and infestations
Infection not assumed related to study medicine
|
47.5%
19/40 • Number of events 22 • 12 months (entire study period)
|
41.5%
17/41 • Number of events 21 • 12 months (entire study period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place