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Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

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. Identifier: NCT01870115
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : June 14, 2018
Information provided by (Responsible Party):
Duquesne University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Dietary Supplement: Fiber Pill Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia
Study Start Date : August 2013
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Fiber pill
2 plant fiber pills taken p.o. (by mouth) nightly for one year
Dietary Supplement: Fiber Pill
This fiber pill has been manufactured to mimic the pill that contains the dietary supplements melatonin (M), strontium citrate (S), vitamin D3 (D) and vitamin K2 (K) in appearance but does not contain the supplements

Active Comparator: strontium/melatonin/Vitamins K2 and D3
2 pills taken p.o. (by mouth) nightly for one year. Each pill contains strontium citrate (225 mg), melatonin (2.5 mg), Vitamin K2 (MK7) (30 mcg) and Vitamin D3 (1000 IU)
Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2
Each pill has been manufactured to contain the dietary supplements 2.5mg melatonin (M), 225mg strontium citrate (S), 1000IU vitamin D3 (D) and 30mcg vitamin K2 (K)

Primary Outcome Measures :
  1. Changes in bone mineral density from baseline to one year following treatment [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01870115

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United States, Pennsylvania
Duquesne University Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
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Principal Investigator: Paula A Witt-Enderby, PhD Duquesne University
Principal Investigator: Mark Swanson, ND Private Practice
Study Data/Documents: Publication  This link exits the site

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Responsible Party: Duquesne University Identifier: NCT01870115    
Other Study ID Numbers: Grant Protocol Number 13-59
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duquesne University:
Strontium Citrate
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Protective Agents
Central Nervous System Depressants