Trial record 2 of 117 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
  Purpose

Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep disturbances when compared to their placebo controls since melatonin is known to modulate estrogen levels in the body and regulate sleep. The data from these studies may provide novel and alternative uses for melatonin; in particular its use for the prevention and/or treatment of osteoporosis.


Condition Intervention Phase
Osteoporosis
Osteopenia
Dietary Supplement: melatonin
Dietary Supplement: sugar pill
Phase 1

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
Official Title: Assessing the Efficacy of Melatonin on Bone Health in Peri-menopausal Women

Resource links provided by NLM:


Further study details as provided by Duquesne University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Nature's Bounty Melatonin
  • Natrol Melatonin
  • Spring Valley Melatonin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 54 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152580

Locations
United States, Pennsylvania
Duquesne University School of Pharmacy Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
Investigators
Principal Investigator: Paula A Witt-Enderby, PhD Duquesne University School of Pharmacy
Principal Investigator: Judith L Balk, MD Magee-Womens Hospital, University of Pittsburgh
  More Information

Additional Information:
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

Keywords provided by Duquesne University:
melatonin
menopause
perimenopause
sleep
osteoporosis
osteopenia
anxiety
depression
hypertension

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014