Trial record 2 of 113 for:    MOPS

Melatonin Osteoporosis Prevention Study (MOPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duquesne University
ClinicalTrials.gov Identifier:
NCT01152580
First received: June 28, 2010
Last updated: March 9, 2012
Last verified: March 2012
Results First Received: January 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Osteoporosis
Osteopenia
Interventions: Dietary Supplement: melatonin
Dietary Supplement: sugar pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Sugar Pill Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Melatonin Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months

Participant Flow:   Overall Study
    Sugar Pill     Melatonin  
STARTED     5     14  
COMPLETED     5     13  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
Melatonin Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Melatonin     Total  
Number of Participants  
[units: participants]
  5     13     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     13     18  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.5  ± 2.0     50.3  ± 3     49.5  ± 3.0  
Gender  
[units: participants]
     
Female     5     13     18  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     5     13     18  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     5     13     18  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  21.7  ± 3.5     25.7  ± 3.7     24.6  ± 4.0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Baseline and 6 months ]

2.  Primary:   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.   [ Time Frame: Baseline and 6 months ]

3.  Primary:   The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   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.   [ Time Frame: Baseline and 6 mos ]

5.  Secondary:   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.   [ Time Frame: Baseline and 6 mos ]

6.  Secondary:   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.   [ Time Frame: Baseline and 6 mos ]

7.  Secondary:   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.   [ Time Frame: Baseline and 6 mos ]

8.  Secondary:   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.   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Dr. Paula Witt-Enderby, Professor of Pharmacology and Toxicology
Organization: Duquesne University
phone: 412-396-4346
e-mail: wittp@duq.edu


Publications of Results:
Other Publications:


Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT01152580     History of Changes
Other Study ID Numbers: 07-88
Study First Received: June 28, 2010
Results First Received: January 4, 2012
Last Updated: March 9, 2012
Health Authority: United States: Institutional Review Board