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: August 19, 2015
Last verified: August 2015
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 Intervention Phase
Dietary Supplement: Fiber Pill
Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Duquesne University:

Primary Outcome Measures:
  • Changes in bone mineral density from baseline to one year following treatment [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Genders 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01870115

United States, Pennsylvania
Duquesne University Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
Principal Investigator: Paula A Witt-Enderby, PhD Duquesne University
Principal Investigator: Mark Swanson, ND Private Practice
  More Information

Responsible Party: Duquesne University Identifier: NCT01870115     History of Changes
Other Study ID Numbers: Grant Protocol Number 13-59 
Study First Received: June 3, 2013
Last Updated: August 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duquesne University:
Strontium Citrate

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Citric Acid
Vitamin D
Vitamin K
Vitamin K 2
Vitamin MK 7
Antifibrinolytic Agents
Bone Density Conservation Agents
Calcium Chelating Agents
Central Nervous System Depressants
Chelating Agents
Fibrin Modulating Agents
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Sequestering Agents processed this record on May 26, 2016