Seattle, WA, Aug 6 – Mark Swanson, ND (shown on the right), naturopathic physician from Sequim, Washington (Bastyr,1984) has been treating his osteopenia / osteoporosis patients with his FOOT Plan (Fully Optimized Osteoporosis Therapy) for the past seven years. The results have consistently shown improvements in bone density and fracture reductions. (NDNR, Jan 2010, www.NDNR.com).
The FOOT Plan's combination of all natural ingredients has eliminated the need for osteoporosis drugs in the majority of his patients. “In our experience it works better, faster and is safer. A unique aspect of the protocol is the concept of melatonin chronosynergy
, which combines strontium and melatonin together at night to improve the anabolic effects on bone formation”, said Swanson.
Dr. Paula Witt-Enderby, professor of pharmacology at Duquesne University, PA has recently published melatonin research on bone loss too. Her MOPS study (Melatonin Osteoporosis Prevention Study) published in the J Pineal Research, May 2012,
examined whether melatonin, a natural pineal hormone and over-the-counter sleep aid could help prevent bone loss in healthy women entering menopause. The answer was yes.
Now both are collaborating and expanding on each others work with melatonin and bone support to include a follow-up study with women diagnosed with osteopenia. With a translational research grant from Duquesne Mylan School of Pharmacy and the study formulation provided by Pure Encapsulations, Inc., Sudbury, Mass., Witt-Enderby and her research team with Dr. Swanson will study a unique nutraceutical formulation consisting of a combination of melatonin, strontium citrate, with vitamin's D3 and K2. “The population burden of fractures occurs far more with osteopenia than osteoporosis. That's the best time to intervene”, said Swanson.
“Melatonin has profound health promoting effects in many organs and tissues of the body, including bone. We hypothesize that melatonin will have a chronosynergyeffect with strontium in bone that is greater than strontium alone and at a lower dose. We think it makes better bone building sense when given both together at night,” said Witt-Enderby.
The mineral strontium outperforms calcium for increasing bone formation and stopping bone loss. It's safe and starts to increase bone density and reduce fractures within weeks. Vitamin D3 and K2 (MK7) are included in the study formula because they also have a synergy effect on bone strength and quality. “We think melatonin will also act as a catalyst and give an extra bone building boost to the other three ingredients. Besides sleep quality, melatonin is good for the heart, blood sugar, blood pressure and belly fat too. It's icing on the cake”, Swanson added.
The clinical trial is scheduled to start in late summer 2013, and will be based in the Dusquesne Center for Pharmacy Care, Uptown, PA. Members of Dr. Witt-Enderby's study team will conduct the double blind, placebo controlled study. Osteopenia participants will be assigned to take either two capsules of the study formulation or a placebo at bedtime for one year. Each will have DXA scans (dual-energy X-ray absorptiometry), bone turnover markers tests, health assessments and be asked to keep diaries. A third arm of the study will also test each formulation ingredient on cell culture lines for bone associated responses.
“Current drug treatments for osteoporosis are not ideal. Osteopenia treatment is usually postponed until it advances to osteoporosis. Then it's only at about 30% compliance, which really drops after 6 months”, said Witt-Enderby. “What's needed is a natural, convenient, well tolerated, effective, preemptive therapy. In the end, its all about normalizing bone density, restoring quality bone, preventing fractures, and improving quality of life in the most amount people who need it”, she added.
“This study isn't about waiting for advanced boned loss or comparing efficacy with osteoporosis drugs. It's about prevention and avoiding the need for the drugs altogether”, said Dr. Swanson.
Mark Swanson, ND 360 683-1110 firstname.lastname@example.org
Paula-Witt Enderby, PhD (412) 396-4346 email@example.com
Division of Pharmaceutical Sciences, 421 Mellon Hall, Duquesne University School of Pharmacy, Pittsburgh, PA 15282