MOTS: Melatonin-Micronutrients for Osteopenia Treatment Study

Sponsor

Duquesne University (Other)

Overall Status

Completed

CT.gov ID

NCT01870115

Collaborator

(none)

Enrollment

Location

Arms

42.3

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Osteopenia	Dietary Supplement: Fiber Pill Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Feb 9, 2017

Actual Study Completion Date :

Feb 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Changes in bone mineral density from baseline to one year following treatment [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes 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.