Melatonin-Micronutrients for Osteopenia Treatment Study
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/16/2018 |
| Start Date: | August 2013 |
| End Date: | February 9, 2017 |
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.
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.
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.
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