Melatonin-Micronutrients for Osteopenia Treatment Study

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Dietary Supplement: Fiber Pill
* Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fiber pill<br>2 plant fiber pills taken p.o. (by mouth) nightly for one year | Dietary Supplement: Fiber Pill<br>* 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<br>|
| Active Comparator: strontium/melatonin/Vitamins K2 and D3<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mineral density from baseline to one year following treatment |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Strontium Citrate, Osteoporosis, Osteopenia