Overview

This trial is active, not recruiting.

Conditions osteoporosis, osteopenia
Treatments fiber pill, melatonin, strontium citrate, vitamins d3 and k2
Phase phase 1
Sponsor Duquesne University
Start date August 2013
End date January 2016
Trial size 20 participants
Trial identifier NCT01870115, Grant Protocol Number 13-59

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
2 plant fiber pills taken p.o. (by mouth) nightly for one year
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)
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)
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)

Primary Outcomes

Measure
Changes in bone mineral density from baseline to one year following treatment
time frame: One year

Eligibility Criteria

Female participants of any age.

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.

Additional Information

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
Principal investigator Paula A Witt-Enderby, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Duquesne University.