Trial record 2 of 3 for:    melatonin and osteoporosis

Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duquesne University
ClinicalTrials.gov Identifier:
NCT01870115
First received: June 3, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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
Osteoporosis
Osteopenia
Dietary Supplement: Fiber pill
Drug: Strontium citrate/melatonin/Vitamins K2 and D3
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: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fiber pill
2 fiber pills given p.o. nightly for one year
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)
Drug: Strontium citrate/melatonin/Vitamins K2 and D3

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01870115

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

No publications provided

Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT01870115     History of Changes
Other Study ID Numbers: Grant Protocol Number 13-59
Study First Received: June 3, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duquesne University:
Melatonin
Strontium Citrate
Osteoporosis
Osteopenia

Additional relevant MeSH terms:
Osteoporosis
Melatonin
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin K
Vitamin K 2
Vitamins
Vitamin MK 7
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Hematologic Agents
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 18, 2014