Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melatonin Osteoporosis Prevention Study (MOPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01152580
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : March 12, 2012
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Duquesne University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Osteoporosis
Osteopenia
Interventions Dietary Supplement: melatonin
Dietary Supplement: sugar pill
Enrollment 19
Recruitment Details Recruitment started in September, 2008 and continued through February, 2010 using neighborhood and city newspapers, posting of flyers, on-campus advertising and news features in campus, local and city newspapers and the local news. Eligible subjects reported to the Center for Pharmacy Care at Duquesne University for screenings and assessments.
Pre-assignment Details Eligible subjects were randomly assigned using a computer-generated randomization scheme to receive either placebo or melatonin at a 3:1 ratio (treatment:placebo). Participants and principle investigators were completely blinded to the group assignments throughout the entire study thus achieving allocation concealment.
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Period Title: Overall Study
Started 5 14
Completed 5 13
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Sugar Pill Melatonin Total
Hide Arm/Group Description Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months Total of all reporting groups
Overall Number of Baseline Participants 5 13 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
13
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 13 participants 18 participants
47.5  (2.0) 50.3  (3) 49.5  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 18 participants
Female
5
 100.0%
13
 100.0%
18
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 18 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
13
 100.0%
18
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 13 participants 18 participants
5 13 18
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 5 participants 13 participants 18 participants
21.7  (3.5) 25.7  (3.7) 24.6  (4.0)
1.Primary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline
Hide Description Osteocalcin is a measure of osteoblast activity because it is secreted from osteoblasts. Osteocalcin levels were measured in the serum of women at baseline and after 6 months of taking placebo or melatonin (3 mg) and the data are reported as ng/mL. Osteoblasts are bone-forming cells so a more positive mean change in osteoblast activity over time (6 months - baseline) could indicate an improvement in bone mineral density. A more negative mean change in osteocalcin levels over time (6 months - baseline) could indicate a worsening of bone mineral density.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.6  (0.596) 1.83  (1.066)
2.Primary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Type-1 Collagen Cross-linked N-telopeptide (NTX) Levels in Women After 6 Months, as Compared to Baseline.
Hide Description Type-1 collagen cross-linked N-telopeptide (NTX) levels were measured in the serum of women at baseline and after taking placebo or melatonin (3 mg) nightly for 6 months. NTX, reported as bone collagen equivalents (BCE), is released from bone due to the actions of osteoclasts or bone breakdown cells. A more positive mean change in NTX levels (6 months - baseline) could result in a worsening of bone mineral density due to an increase in bone breakdown whereas a more negative mean change in NTX levels could result in an improvement in bone mineral density due to a decrease in bone breakdown.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: nM BCE
-0.36  (0.97) -0.32  (1.4)
3.Primary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.
Hide Description The mean change in bone mineral density (BMD), represented by T-scores, was assessed by calcaneal ultrasound in women taking melatonin (3 mg) or placebo nightly at baseline and after 6 months. A T-score is a comparison of a subject's BMD to that of a healthy 30 year old female of the same ethnicity. The more negative the T-score, the worse the BMD. Osteoporosis or brittle bone disease is defined as a T-score -2.5 or less. A more negative mean change in a T-score would indicate a worsening of BMD. A more positive mean change in a T-score would indicate an improvement of BMD.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: T-score
-0.02  (0.113) 0.05  (0.01)
4.Secondary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Physical Domain Scores in Women After 6 Months, as Compared to Baseline.
Hide Description Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of "not bothered" (score 0) or "bothered ranging from 1(not too bothered) to 6 (really bothered)". A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms.
Time Frame Baseline and 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (0.5) -0.6  (0.8)
5.Secondary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Vasomotor Domain Scores in Women After 6 Months, as Compared to Baseline.
Hide Description Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of "not bothered" (score 0) or "bothered ranging from 1(not too bothered) to 6 (really bothered)". A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms.
Time Frame Baseline and 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.4) 0.4  (1.8)
6.Secondary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Psychosocial Domain Scores in Women After 6 Months, as Compared to Baseline.
Hide Description Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of "not bothered" (score 0) or "bothered ranging from 1(not too bothered) to 6 (really bothered)". A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms.
Time Frame Baseline and 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.3) -0.4  (1.3)
7.Secondary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Sexual Domain Scores in Women After 6 Months, as Compared to Baseline.
Hide Description Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of "not bothered" (score 0) or "bothered ranging from 1(not too bothered) to 6 (really bothered)". A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms.
Time Frame Baseline and 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (1.4) -0.4  (1.2)
8.Secondary Outcome
Title The Effect of Melatonin (3 mg) or Placebo on the Mean Change in the Pittsburgh Sleep Quality Index (PSQI) in Women After 6 Months, as Compared to Baseline.
Hide Description Pittsburgh Sleep Quality Index (PSQI) Questionnaire is a validated questionnaire that assesses the quality and quantity of sleep and sleep disorders.This survey is designed to identify “good” and “poor” sleepers and has a score scale that ranges from "0-21" with "0" being good quality of sleep and "21" being poor quality of sleep and/or indicating as having a sleep disorder. A more positive mean change in the PSQI over time indicates a worsening of sleep. A more negative mean change in the PSQI over time indicates an improvement in sleep.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description:
Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (1.4) -0.5  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Melatonin
Hide Arm/Group Description Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
All-Cause Mortality
Sugar Pill Melatonin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Melatonin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugar Pill Melatonin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/13 (0.00%) 
Limitations to this study include small sample sizes, length of follow-up, and heterogeneity in terms of stage of perimenopause and prevalence of menopausal symptoms.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paula Witt-Enderby, Professor of Pharmacology and Toxicology
Organization: Duquesne University
Phone: 412-396-4346
EMail: wittp@duq.edu
Other Publications:
www.osteo.org. Osteoporosis Overview. National Institute of Health Osteoporosis and Related Bone Disease. June 2005.
Layout table for additonal information
Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT01152580     History of Changes
Other Study ID Numbers: 07-88
First Submitted: June 28, 2010
First Posted: June 29, 2010
Results First Submitted: January 4, 2012
Results First Posted: March 12, 2012
Last Update Posted: March 13, 2012