Osteoporosis — Melatonin Osteoporosis Prevention Study
Citation(s)
Bonnick SL, Shulman L Monitoring osteoporosis therapy: bone mineral density, bone turnover markers, or both? Am J Med. 2006 Apr;119(4 Suppl 1):S25-31. Review.
Burgess HJ, Revell VL, Eastman CI A three pulse phase response curve to three milligrams of melatonin in humans. J Physiol. 2008 Jan 15;586(2):639-47. Epub 2007 Nov 15. Erratum in: J Physiol. 2008 Mar 15;586(6):1777.
Koyama H, Nakade O, Takada Y, Kaku T, Lau KH Melatonin at pharmacologic doses increases bone mass by suppressing resorption through down-regulation of the RANKL-mediated osteoclast formation and activation. J Bone Miner Res. 2002 Jul;17(7):1219-29.
Ostrowska Z, Kos-Kudla B, Marek B, Kajdaniuk D Influence of lighting conditions on daily rhythm of bone metabolism in rats and possible involvement of melatonin and other hormones in this process. Endocr Regul. 2003 Sep;37(3):163-74.
Parfitt AM, Villanueva AR, Foldes J, Rao DS Relations between histologic indices of bone formation: implications for the pathogenesis of spinal osteoporosis. J Bone Miner Res. 1995 Mar;10(3):466-73.
Radio NM, Doctor JS, Witt-Enderby PA Melatonin enhances alkaline phosphatase activity in differentiating human adult mesenchymal stem cells grown in osteogenic medium via MT2 melatonin receptors and the MEK/ERK (1/2) signaling cascade. J Pineal Res. 2006 May;40(4):332-42.
Ray NF, Chan JK, Thamer M, Melton LJ 3rd Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation. J Bone Miner Res. 1997 Jan;12(1):24-35.
Sethi S, Radio NM, Kotlarczyk MP, Chen CT, Wei YH, Jockers R, Witt-Enderby PA Determination of the minimal melatonin exposure required to induce osteoblast differentiation from human mesenchymal stem cells and these effects on downstream signaling pathways. J Pineal Res. 2010 Oct;49(3):222-38. doi: 10.1111/j.1600-079X.2010.00784.x. Epub 2010 Jul 6. Erratum in: J Pineal Res. 2011 Apr;50(3):356.
Witt-Enderby PA, Radio NM, Doctor JS, Davis VL Therapeutic treatments potentially mediated by melatonin receptors: potential clinical uses in the prevention of osteoporosis, cancer and as an adjuvant therapy. J Pineal Res. 2006 Nov;41(4):297-305. Review.
Wolinsky FD, Fitzgerald JF, Stump TE The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403.
www osteo.org. Osteoporosis Overview. National Institute of Health Osteoporosis and Related Bone Disease. June 2005.
Assessing the Efficacy of Melatonin on Bone Health in Peri-menopausal Women
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.