Clinical trial NCT01870115: Melatonin-Micronutrients for Osteopenia Treatment Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Osteopenia
Keywords: Melatonin
Strontium Citrate
Osteoporosis
Osteopenia
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Changes in bone mineral density from baseline to one year following treatment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University Center for Pharmacy Care
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Paula A Witt-Enderby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice
name: Mark Swanson, ND
role: PRINCIPAL_INVESTIGATOR
References: