Melatonin Osteoporosis Prevention Study (MOPS)
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ClinicalTrials.gov Identifier: NCT01152580 |
Recruitment Status :
Completed
First Posted : June 29, 2010
Results First Posted : March 12, 2012
Last Update Posted : March 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Osteopenia | Dietary Supplement: melatonin Dietary Supplement: sugar pill | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Assessing the Efficacy of Melatonin on Bone Health in Peri-menopausal Women |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sugar pill |
Dietary Supplement: sugar pill
lactose p.o. at bedtime daily
Other Name: Lactose |
Active Comparator: melatonin |
Dietary Supplement: melatonin
3mg p.o. at bedtime daily
Other Names:
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- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.

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Ages Eligible for Study: | 45 Years to 54 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Inclusion criteria include perimenopausal women,
- willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program.
- Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication.
Exclusion Criteria:
- Exclusion criteria will include women in whom osteopenia is a result of some other known process such as hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use.
- Those individuals on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine or those with severe sleep apnea, severe COPD and those with moderate or severe hepatic impairment will also be excluded.
- Individuals who are lactose intolerant will also be excluded because the placebo and melatonin capsules will contain lactose.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152580
United States, Pennsylvania | |
Duquesne University School of Pharmacy Center for Pharmacy Care | |
Pittsburgh, Pennsylvania, United States, 15282 |
Principal Investigator: | Paula A Witt-Enderby, PhD | Duquesne University School of Pharmacy | |
Principal Investigator: | Judith L Balk, MD | Magee-Womens Hospital, University of Pittsburgh |
Publications of Results:
Other Publications:
Responsible Party: | Duquesne University |
ClinicalTrials.gov Identifier: | NCT01152580 |
Other Study ID Numbers: |
07-88 |
First Posted: | June 29, 2010 Key Record Dates |
Results First Posted: | March 12, 2012 |
Last Update Posted: | March 13, 2012 |
Last Verified: | March 2012 |
melatonin menopause perimenopause sleep osteoporosis |
osteopenia anxiety depression hypertension |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Melatonin |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |