Bagi CM, Berryman E, Zakur DE, Wilkie D, Andresen CJ Effect of antiresorptive and anabolic bone therapy on development of osteoarthritis in a posttraumatic rat model of OA. Arthritis Res Ther. 2015 Nov 6;17:315. doi: 10.1186/s13075-015-0829-5.
Buckland-Wright JC, Messent EA, Bingham CO 3rd, Ward RJ, Tonkin C A 2 yr longitudinal radiographic study examining the effect of a bisphosphonate (risedronate) upon subchondral bone loss in osteoarthritic knee patients. Rheumatology (Oxford). 2007 Feb;46(2):257-64. Epub 2006 Jul 11.
Dearmin MG, Trumble TN, García A, Chambers JN, Budsberg SC Chondroprotective effects of zoledronic acid on articular cartilage in dogs with experimentally induced osteoarthritis. Am J Vet Res. 2014 Apr;75(4):329-37. doi: 10.2460/ajvr.75.4.329. Erratum in: Am J Vet Res. 2014 Jun;75(6):594.
Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Econ. 2018 Jan;27(1):7-22. doi: 10.1002/hec.3564. Epub 2017 Aug 22.
Dobson F, Hinman RS, Hall M, Marshall CJ, Sayer T, Anderson C, Newcomb N, Stratford PW, Bennell KL Reliability and measurement error of the Osteoarthritis Research Society International (OARSI) recommended performance-based tests of physical function in people with hip and knee osteoarthritis. Osteoarthritis Cartilage. 2017 Nov;25(11):1792-1796. doi: 10.1016/j.joca.2017.06.006. Epub 2017 Jun 22.
Duarte JH Osteoarthritis: alendronate treatment improves pathology in animal model of OA by blocking osteoclastic bone resorption. Nat Rev Rheumatol. 2014 Aug;10(8):446. doi: 10.1038/nrrheum.2014.107. Epub 2014 Jul 8.
Duarte Sosa D, Fink Eriksen E Women with previous stress fractures show reduced bone material strength. Acta Orthop. 2016 Dec;87(6):626-631. Epub 2016 Jun 20.
Laslett LL, Kingsbury SR, Hensor EM, Bowes MA, Conaghan PG Effect of bisphosphonate use in patients with symptomatic and radiographic knee osteoarthritis: data from the Osteoarthritis Initiative. Ann Rheum Dis. 2014 May;73(5):824-30. doi: 10.1136/annrheumdis-2012-202989. Epub 2013 Apr 12.
Maas O, Joseph GB, Sommer G, Wild D, Kretzschmar M Association between cartilage degeneration and subchondral bone remodeling in patients with knee osteoarthritis comparing MRI and (99m)Tc-DPD-SPECT/CT. Osteoarthritis Cartilage. 2015 Oct;23(10):1713-20. doi: 10.1016/j.joca.2015.05.014. Epub 2015 May 29.
Miller PD The kidney and bisphosphonates. Bone. 2011 Jul;49(1):77-81. doi: 10.1016/j.bone.2010.12.024. Epub 2011 Jan 11. Review.
Prieto-Potin I, Largo R, Roman-Blas JA, Herrero-Beaumont G, Walsh DA Characterization of multinucleated giant cells in synovium and subchondral bone in knee osteoarthritis and rheumatoid arthritis. BMC Musculoskelet Disord. 2015 Aug 27;16:226. doi: 10.1186/s12891-015-0664-5.
Richette P, Roux C Impact of treatments for osteoporosis on cartilage biomarkers in humans. Osteoporos Int. 2012 Dec;23 Suppl 8:S877-80. doi: 10.1007/s00198-012-2165-9. Epub 2012 Nov 22. Review.
Sellam J, Berenbaum F The role of synovitis in pathophysiology and clinical symptoms of osteoarthritis. Nat Rev Rheumatol. 2010 Nov;6(11):625-35. doi: 10.1038/nrrheum.2010.159. Epub 2010 Oct 5. Review.
Shabestari M, Vik J, Reseland JE, Eriksen EF Bone marrow lesions in hip osteoarthritis are characterized by increased bone turnover and enhanced angiogenesis. Osteoarthritis Cartilage. 2016 Oct;24(10):1745-1752. doi: 10.1016/j.joca.2016.05.009. Epub 2016 May 24. Erratum in: Osteoarthritis Cartilage. 2017 Apr;25(4):611.
Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M Comment on: Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study: reply. Rheumatology (Oxford). 2015 Nov;54(11):2117-8. doi: 10.1093/rheumatology/kev302. Epub 2015 Sep 2.
Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study. Rheumatology (Oxford). 2015 Oct;54(10):1826-32. doi: 10.1093/rheumatology/kev123. Epub 2015 May 20.
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.