Fracture healing: a consensus report from the International Osteoporosis Foundation Fracture Working Group
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We used the RAND UCLA appropriateness method to decide appropriateness of use of osteoporosis medication after incident fracture and potential for fracture healing and make suggestions for trial design for clinical and preclinical research.
To develop appropriateness criteria to assist in the use and study of osteoporosis medications in patients with recent fracture and in the potential use of osteoporosis medications to enhance delayed fracture healing. To promote further research by suggesting preclinical and clinical trial design for studies where fracture healing is the endpoint.
Design: RAND/UCLA appropriateness method (RUAM). Participants: A panel of experts, both members and non-members of the International Osteoporosis Foundation Fracture Working Group, were identified consisting of geriatricians, rheumatologists, orthopedists, endocrinologists, and internists. This resulted in a round 1 panel of 15 panelists, round 2 panel of 15 members, and a round 3 panel of 14 members. Main outcome measure: Agreement on statements and scenarios using RUAM. Three rounds of voting by panelists took place. Agreement in a third round was reached for 111 statements and scenarios, measured by median panel ratings and the amount of dispersion of panel ratings, based on the interpercentile range.
An expert panel validated a set of statements and scenarios about the use of osteoporosis medications after incident fracture and use of these medications to enhance delayed fracture healing and made recommendations for study designs to investigate the effect of osteoporosis medications on fracture healing.
The result of this exercise is intended to assist in improving patient care by identifying the appropriateness of use of osteoporosis medications after fracture and in fracture healing and to make suggestions for further preclinical and clinical research.
KeywordsFracture healing Osteoporotic fracture Trial design
Conflicts of interest
Stuart Silverman is a consultant for Amgen, Alexion, Eli Lilly, and Pfizer. He is a member of the Speakers Bureau for Lilly and Pfizer. He has received research grants from Pfizer, Lilly, and Amgen. Susan V. Bukata is a consultant for Amgen and Eli Lilly and a member of the Speakers Bureau for Eli Lilly, Amgen, and Novartis. Eli Kupperman has no disclosures.
- 1.The Rand UCLA Appropriateness method user’s manual (2001) Rand Corporation, Los AngelesGoogle Scholar
- 2.Hemingway H, Crook AM, Banerjee S, Dawson JR, Feder G, Magee PG, Wood A, Philpott S, Timmis A (2001) Hypothetical ratings of coronary angiography appropriateness: are they associated with actual angiographic findings, mortality, and revascularisation rate? The ACRE study. Heart 85:672–679CrossRefPubMedPubMedCentralGoogle Scholar
- 9.Colon-Emeric CX, Nordslettern L, Olson S, Major N, Boonen S, Haentjens P, Mesenbrink P, Magaziner J, Adachi J, Lyles KW, et al. (2011) Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int 22(8):2329–36Google Scholar
- 17.Adami S, Libanati C, Boonen S, Cummings SR, Ho PR, Wang A, Siris E, Lane J, FREEDOM Fracture-Healing Writing Group (2012) Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. J Bone Joint Surg 94:2113–2119CrossRefPubMedGoogle Scholar
- 19.Andreassen TT,Ejersted C, Oxlund H (1999) Intermittent parathyroid (1–34) treatment increases callus formation and mechanical strength of healing rat fractures. J Bone Miner Res 14:960–8Google Scholar
- 20.Alkhiary YM, Gerstenfeld LC, Krall E, Westmore M, Sato M, Mitlak B, Einhorn TA (2005) Enhancement of experimental fracture healing by systemic administration of human parathyroid hormnone (PTH 1–34). 87: 731–41Google Scholar
- 25.Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, García-Hernández PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC (2010) Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res 25:404–414CrossRefPubMedGoogle Scholar
- 32.Ohtori S, Inoue G, Orita S, Yamauchi K, Eguchi Y, Ochiai N, Kishida S, Kuniyoshi K, Aoki Y, Nakamura J, Ishikawa T, Miyagi M, Kamoda H, Suzuki M, Kubota G, Sakuma Y, Oikawa Y, Inage K, Sainoh T, Takaso M, Ozawa T, Takahashi K, Toyone T (2012) Teriparatide accelerates lumbar posterolateral fusion in women with postmenopausal osteoporosis: prospective study. Spine 37:E1464–E1468CrossRefPubMedGoogle Scholar
- 33.European Medicine Agency (2013) Recommendations to restrict the use of Protelos/Osseor (strontium ranelate). www.ema.europa.edu/docs/en_GB/document_library/Press_release/2013/04/wc500142507.pdfAccessed May 25,2015
- 38.Aslam MZ, Khan MA, Chinoy MA, Jillani SA, Sultan SA, Ahmed SK (2014)Significance of strontium ranelate in healing of surgically fixed tibial diaphyseal fractures treated with strontium ranelate vs placebo; a randomised double blind controlled trial. 64(12 Suppl 2):S123-6Google Scholar
- 39.Scaglione M, Fabbri L, Casella F, Guido G (2015) Strontium ranelate as an adjuvant for fracture healing: clinical, radiological, and ultrasound findings in a randomized controlled study on wrist fractures. Osteoporos IntGoogle Scholar
- 50.Bhandari M, Chiavaras MM, Parasu N, et al. (2013) Radiographic union score for hip substantially improves agreements between surgeons and radiologists. BMC Musculoskelet Disord 14: article 70Google Scholar
- 60.Adler RA, Fuleihan GE, Bauer DC, Camacho PM, Clarke BL, Clines GA, Compston JE, Drake MT, Edwards BJ, Favus MJ, Greenspan SL, McKinney R, Pignolo RJ, Sellmeyer DE (2016) Managing osteoporosis in patients on long-term bisphosphonate treatment: report of a task force of the American Society of Bone and Mineral Research. J Bone Miner Res 31(1):16–35CrossRefPubMedPubMedCentralGoogle Scholar
- 62.Miyakoshi N, Aizawa T, Sasaki S, Ando S, Maekawa S, Aonuma H, Tsuchie H, Sasaki H, Kasukawa Y, Shimada Y (2015) Healing of bisphosphonate-associated atypical femoral fractures in patients with osteoporosis: a comparison between treatment with and without teriparatide. J Bone Miner Metab 33(5):553–559CrossRefPubMedGoogle Scholar