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Trial record 2 of 3 for:    melatonin and osteoporosis

Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Duquesne University Identifier:
First received: June 3, 2013
Last updated: July 9, 2014
Last verified: July 2014

June 3, 2013
July 9, 2014
August 2013
August 2015   (final data collection date for primary outcome measure)
Changes in bone mineral density from baseline to one year following treatment [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01870115 on Archive Site
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Melatonin-Micronutrients for Osteopenia Treatment Study
Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia

The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well as improve quality of life (QOL). These conditions generally begin silently as early as the menopause transition and progress to osteopenia and osteoporosis during the post-menopausal years in aging women. The investigators also envision this will be beneficial in aging andropausal men with these conditions. The investigators postulate that melatonin in novel combination with other natural bone-protective agents may act in a "chronosynergy" manner to prevent and correct these perturbations, reducing the risk of bone fractures, and lessening the stiffness and pain associated with bone, joint and cartilage degeneration and improving quality of life (QOL). The objective here, which is the investigators' next step in pursuit of our goal, is to assess the efficacy of an alternative therapy that uses a novel combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to current treatment(s) because it has multiple bone-protective and sleep-promoting activities within the body, and it is relatively safe so it can be used in an aging population without untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and improve post-menopausal osteoporosis. The project goal is to identify if this combination therapy improves bone health and QOL compared to women taking placebo. The investigators' central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by improving subjective measures of stress, anxiety, depression and menopause-related symptoms.

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Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Osteopenia
  • Dietary Supplement: Fiber pill
  • Drug: Strontium citrate/melatonin/Vitamins K2 and D3
  • Placebo Comparator: Fiber pill
    2 fiber pills given p.o. nightly for one year
    Intervention: Dietary Supplement: Fiber pill
  • Active Comparator: strontium/melatonin/Vitamins K2 and D3
    2 pills given p.o. nightly containing strontium citrate (450 mg), melatonin (5 mg), Vitamin K2 (MK7) (60 mcg) and Vitamin D3 (2000 IU)
    Intervention: Drug: Strontium citrate/melatonin/Vitamins K2 and D3
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • postmenopausal
  • must be osteopenic (T-score between -2.5 and -1)
  • willingness to participate in the 12-month study
  • willingness to undergo testing of bone turnover markers before and after the drug therapies
  • willingness to provide a self-assessment on quality of life throughout the program
  • willingness to take their treatments right before bed
  • willingness to not to consume alcohol with this medication

Exclusion Criteria:

  • women in whom osteopenia is a result of some other known process (e.g. hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use).
  • women on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine
  • women with severe sleep apnea, severe COPD and those with moderate or severe hepatic or renal impairment.
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
Grant Protocol Number 13-59
Duquesne University
Duquesne University
Not Provided
Principal Investigator: Paula A Witt-Enderby, PhD Duquesne University
Principal Investigator: Mark Swanson, ND Private Practice
Duquesne University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP