Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health, vol. -, no. -, 1e6, 2013� Copyright 2013 by The International Society for Clinical Densitometry1094-6950/-:1e6/$36.00

http://dx.doi.org/10.1016/j.jocd.2013.06.002

Original Article

Consensus of Official Position of IOF/ISCD FRAX Initiativesin Asia-Pacific Region

Chih-Hsing Wu,*,1 Eugene V. McCloskey,2 Joon Kiong Lee,3 Akira Itabashi,4

Richard Prince,5 Wei Yu,6 Julie Li-Yu,7 Siok Bee Chionh,8 Yanling Zhao,9

Chan Soo Shin,10 Tirtarahardja Gunawan,11 Keh-Sung Tsai,12 Poon-Ung Chieng,13

Sheng-Pin Changlai,14 Ding-Cheng Chan,15 Jung-Fu Chen,16 S. Bobo Tanner,17

Didier B. Hans,18 John A. Kanis,19 Yin-Fan Chang,1 Zih-Jie Sun,20 and Rong-Sen Yang,21

on behalf of the Asia Pacific Panel of ISCD1Department of Family Medicine, National Cheng Kung University Hospital and College of Medicine, Tainan, Taiwan;

2Academic Unit of Bone Metabolism, University of Sheffield, Sheffield, UK; 3Osteoporosis Treatment Centre, KualaLumpur, Malaysia; 4SCBR (Saitama Center for Bone Research), Kubojima Clinic, Saitama, Japan; 5Department of

Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia; 6Department of Radiology,Peking Union Medical College Hospital Beijing, Beijing, China; 7Department of Medicine, University of Santo TomasHospital, Manila, Philippines; 8Division of Endocrinology, Department of Medicine, National University Health System,

Singapore; 9Obstetrician and Gynecologist in Beijing United Family Hospital, Beijing, China; 10Seoul NationalUniversity College of Medicine, Seoul, Korea; 11Jakarta Osteoporosis Center, Jakarta, Indonesia; 12Department ofInternal Medicine, National Taiwan University Hospital, Taipei, Taiwan; 13Osteoporosis Center, Taiwan AdventistHospital, Taipei, Taiwan; 14Department of Nuclear Medicine and Radiology, Lin Shin Hospital, Taichung, Taiwan;15Department of Geriatrics and Gerontology, National Taiwan University Hospital, Taipei, Taiwan; 16Division of

Endocrinology and Metabolism, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College ofMedicine, Kaohsiung, Taiwan; 17Division of Rheumatology & Allergy, Vanderbilt University Medical Center, Nashville,TN, USA; 18Center of Bone Diseases, Department of Bone & Joint, Lausanne University Hospital, Lausanne, Switzerland;

19WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK;20Secction of Family Medicine, Department of Internal Medicine, National Cheng Kung University Hospital Dou-LiouBranch, Douliou City, Taiwan; and 21Department of Orthopedics, National Taiwan University Hospital, Taipei, Taiwan

Abstract

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The fracture risk assessment tool (FRAX�) has been developed for the identification of individuals with high riskof fracture in whom treatment to prevent fractures would be appropriate. FRAX models are not yet available for allcountries or ethnicities, but surrogate models can be used within regions with similar fracture risk. The InternationalSociety for Clinical Densitometry (ISCD) and International Osteoporosis Foundation (IOF) are nonprofit multidis-ciplinary international professional organizations. Their visions are to advance the awareness, education, prevention,and treatment of osteoporosis. In November 2010, the IOF/ISCD FRAX initiative was held in Bucharest, bringingtogether international experts to review and create evidence-based official positions guiding clinicians for the prac-tical use of FRAX. A consensus meeting of the Asia-Pacific (AP) Panel of the ISCD recently reviewed the mostcurrent Official Positions of the Joint Official Positions of ISCD and IOF on FRAX in view of the different

ceived 05/27/13; Accepted 06/18/13.ih-HsingWuandRong-SenYangcontributedequally to this study.ddress correspondence to: Chih-Hsing Wu, MD, Departmentmily Medicine, National Cheng Kung University Hospital

and College of Medicine, 138 Sheng-Li Road, Tainan 70428,Taiwan. E-mail: paulo@mail.ncku.edu.tw

1

2 Wu et al.

Journa

population characteristics and health standards in the AP regions. The reviewed position statements included notonly the key spectrum of positions but also unique concerns in AP regions.

Key Words: Bone mineral density; clinical risk factor; fracture; FRAX; osteoporosis.

Introduction

Osteoporotic fracture is an increasing burden among coun-tries of the Asia-Pacific (AP) region (1). For early preventionand effective intervention of osteoporotic fractures, the frac-ture risk assessment tool (FRAX�) estimating an individual’s10-yr major and hip fracture probability has been launched toassist in the identification of individuals at high risk ofosteoporosis-related fractures (2). FRAX is being used bymultidisciplinary professionals worldwide (3) and is updatedperiodically (4). There are approx 2.8 million calculationsconducted via the FRAX Web site annually (http://www.shef.ac.uk/FRAX). In a survey at the first Asian regional os-teoporosis meeting of the International Osteoporosis Founda-tion (IOF) in 2010, 76% of attending experts were aware ofFRAX; however, among them only 62% were using it. Themain reason for not using FRAX was the lack of a country-specific model (5). As of August 2012, only 12 Asian countriesor regions had their own specific FRAX�model demonstratinga need to develop more FRAX models and implement FRAXinto local and/or regional guidelines (4).

The International Society for Clinical Densitometry(ISCD) is an international nonprofit professional society link-ing multiple disciplines with an interest in bone mass mea-surement and assessment of skeletal integrity. The ISCD’smission is to advance excellence in the assessment of skeletalhealth by promoting education and a broader understandingof the clinical applications of bone mass measurement andother skeletal health assessment technologies; assuring profi-ciency and quality in the assessment of skeletal healththrough certification and accreditation; supporting clinicaland scientific advances in the diagnosis and treatment of os-teoporosis; and promoting appropriate patient access tobone mass measurement and other skeletal health assessmenttechnologies.

IOF is a nonprofit, nongovernmental umbrella organizationdedicated to the worldwide fight against osteoporosis, thedisease known as ‘‘the silent epidemic.’’ IOF’s membersdcommittees of scientific researchers, patients, medical and re-search societies, and industry representatives from around theworlddshare a common vision of a world free of osteopo-rotic fractures. IOF currently represents 195 societies in 93 lo-cations.

ISCD and IOF convened the FRAX Position DevelopmentConference (PDC) in Bucharest, Romania, on November 14,2010, following a 2-d joint meeting of ISCD and IOF on the‘‘Interpretation and Use of FRAX in Clinical Practice’’ (6).All IOF/ISCD Official Positions are for worldwide applica-tion. For comprehensive information, these official positionscan be downloaded from the ISCD and IOF Web sites atwww.iscd.org and www.iofbonehealth.org.

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The visions of the AP Panel of ISCD are to enhance aware-ness of methods of prevention of osteoporotic fracture amonghealth professionals, to give regional input from this region(7), to advance the excellence of osteoporotic prevention, aswell as to be one of the most valued partners of ISCD and IOFin improving the regional awareness of health professionals onosteoporosis and its consequent fractures. Tomake FRAXappli-cable to AP regions, the Taiwanese Osteoporosis Association(TOA), ISCD, and IOF organized a 2-d expert panel meetingin Taipei, Taiwan, on August 24 and 25, 2012. Its mission wasto develop a Consensus Statement in the AP regions using theIOF/ISCD official document on the ‘‘Interpretation and Use ofFRAX� in Clinical Practice’’ as the basis. The Expert Panel ofIOF/ISCD was composed of AP Panel members of ISCD;FRAX developers from countries within the AP region; TaskForce members or Expert Panel in the new joint IOF/ISCDPDC; and invited scientists from IOF, ISCD, andTOA.This con-sensus meeting focused on the reviewed official positions in-cluding not only the key spectrum of positions but also uniqueconcerns in AP regions. The following sections are the consen-sus of the IOF/ISCD initiatives as modified for the AP region.The modified statements are highlighted in bold.

Introductory Statements

Considering the practical usage of FRAX, the term of‘‘health professionals’’ would be much better than ‘‘clinician’’as the key user. Putting focus on the osteoporosis-related frac-ture will be the major aim of FRAX. The statement was mod-ified as:

� The fracture risk assessment tool (FRAX) is a computer-based algorithm which uses the easily obtained clinicalrisk factors (CRFs) to estimate an individual’s 10-yearfracture probability.

� It may be utilized by health professionals to assist in theidentification of individuals at high risk for osteoporosis-related fractures.

FRAX: Clinical Statements

The clinical statements enrolled the key clinical risk factors(CRFs) of FRAX and had been summarized by the ClinicalTask Force (8,9). For the convenience, the position was statedaccording to the order of FRAX Web page in a reader-friendly manner. The consensus emphasizes the importanceof prior fracture as the first statement (10) as follows:

� Prior fracture is a very important risk factor for pre-dicting future fractures.

� There is a relationship between number of prior fracturesand subsequent fracture risk. FRAX underestimates

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Asia-Pacific Consensus of Official Position of IOF/ISCD on FRAX 3

fracture probability in persons with a history of multiplefractures.

� There is a relationship between severity of prior vertebralfractures and subsequent fracture risk. FRAX may under-estimate fracture probability in individuals with prevalentsevere vertebral fractures.

� While there is evidence that hip, vertebral, and humeralfractures appear to confer greater risk of subsequent frac-ture than fractures at other sites, quantification of this in-cremental risk in FRAX is not possible.

� A parental history of non-hip fragility fracture may bea risk factor for fracture. FRAX may underestimate frac-ture probability in individuals with a parental history ofnon-hip fragility fracture.

Current smoking is one of the independent CRFs per seand should be highlighted as a new statement. The impactof duration and dosage of tobacco are crucial but cannot bequantified appropriately at present (11).

� Current smoking is a risk factor for fracture.� While there is evidence that duration and dose of tobaccomay impact on fracture risk, quantification of this risk isnot possible.

The experts discussed the unique concerns over the use of glu-cocorticoids in theAP region. Glucocorticoids can bemisused oroverused in different way forms including traditional medicine,herbal drugs, or health foods. The experts agree with the officialpositions related to glucocorticoids (12) but raised concernsabout the possibility of underestimating risks of fracture in indi-viduals with any history of misusage of glucocorticoids.

� There is a dose relationship between glucocorticoid use ofgreater than 3 months and fracture risk. The average doseexposure captured within FRAX is likely to be a predni-sone dose of 2.5e7.5 mg/day or its equivalent. Fractureprobability is under-estimated when prednisone dose isgreater than 7.5 mg/day and is over-estimated when pred-nisone dose is less than 2.5 mg/day.

� Frequent intermittent use of higher doses of glucocorti-coids increases fracture risk. Because of variability inthe dose and dosing schedule, quantification of this riskis not possible.

� High dose inhaled glucocorticoids may be a risk factor forfracture. FRAX may underestimate fracture probability inusers of high dose inhaled glucocorticoids.

� Appropriate glucocorticoid replacement in individualswith adrenal insufficiency has not been shown to increasefracture risk. In such patients, use of glucocorticoidsshould not be included in FRAX calculations.

In Chinese traditional medicine, musculoskeletal pain, forexample during cold weather, is termed ‘‘rheumatism.’’Therefore, patients may get confused and enter a ‘‘yes’’ tothe rheumatoid arthritis input in FRAX. This particularCRF should be confirmed as the diagnosis of rheumatoid ar-thritis by physician only. The experts agree with the officialstatements (13) related to rheumatoid arthritis as follows:

Journal of Clinical Densitometry: Assessment & Management of Muscu

� Impaired functional status in patients with rheumatoid ar-thritis may be a risk factor for clinical fractures. FRAXmay underestimate fracture probability in such patients.

� There is no consistent evidence that non-glucocorticoidmedications for rheumatoid arthritis alter fracture risk.

Fall is arguably the most important CRF not directly in-cluded in the algorithm of FRAX. The experts admit the im-portance of fall (14). However, some of the CRFs in FRAXmay interact with falls or reflect the risk of falling. A newstatement is provided to encompass this consideration. How-ever, this statement is significant only when data showing thequantitative relationship between the falls, FRAX, and frac-tures are available.

� Falls are a risk factor for fractures but are not accommo-dated as an entry variable in the current FRAX model.

� Several factors in the FRAX modeling capture someelements of fall risk.

� Fracture probability may be underestimated in individualswith a history of frequent falls, but quantification of thisrisk is not currently possible.

The biochemical markers are potentially interesting butstill inconclusive in clinical interpretation. Therefore, the of-ficial position related to biochemical markers (15) was sup-ported by the experts.

� Evidence that bone turnover markers predict fracture riskindependent of bone mineral density (BMD) is inconclu-sive. Therefore, bone turnover markers are not included asrisk factors in FRAX.

As in PDC, CRFs such as drinking and secondary osteopo-rosis were not discussed further in the consensus meeting.

FRAX: BMD Statements

FRAX probabilities can be calculated with or withoutBMD, providing convenience in clinical practice (2). In theFRAX� algorithm, only the dual-energy X-ray absorptiome-try (DXA) derived femoral neck BMD or T-score can beused. Many clinicians and experts highlight the desire to in-corporate measurements made at other skeletal sites andalso understand how to interpret discrepancies between differ-ent skeletal sites of BMD, especially the discordance oflumbar-hip BMD. The experts agreed all the statements re-lated to BMD but highlighted the important role of spinalBMD in the future FRAX algorithm as a new statement.The evidence of adjusting FRAX estimation based on theT-score difference between lumbar spine and femoral neckwas reported (16). However, the application of this findingin AP region is still uncertain. The experts addressed thestatement in a relatively soft manner by using ‘‘may’’ andnot ‘‘can’’ in the consensus. Considering the possible influ-ence of vertebral fracture on the spinal BMD and the variouscombination of applicable spinal BMD, the definite applica-tion of spinal BMD needs further investigation. Where theDXA BMD is not easily available, the quantitative ultrasound

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(QUS) is a popular device to be used for the osteoporoticscreening. Although QUS is not recommended for diagnosisor monitoring (7), whether the QUS-derived parameters canplay a role in the FRAX remains interesting and debatable.For heel QUS, the experts follow the official position state-ment (17). FRAX can provide more precise fracture riskprobability based on CRFs or BMD alone. The experts rec-ommend generating the FRAX score at the DXA scan report,if available. The consensus of BMD statements were asfollows:

� Measurements other than BMD or T-score at the femoralneck by DXA are not recommended for use in FRAX.

� FRAX may underestimate or overestimate major osteopo-rotic fracture risk when lumbar spine T-score is muchlower or higher (O1 Standard Deviation discrepancy)than femoral neck T-score.

� The incorporation of spinal BMD in the future FRAXalgorithm is plausible.

� A procedure based upon the difference (off set) betweenthe Lumbar Spine and Femoral Neck T-scores may en-hance fracture prediction in the current version of FRAX.

� The ISCD 2007 PDC Statements on fracture risk predic-tion and application of heel Quantitative Ultrasounds(QUS) are supported by a higher level of evidence inmen and women than was available in 2007.

� Currently validated heel QUS devices, using criteria de-fined in the 2007 ISCD PDC, predict fracture risk simi-larly.

� FRAX with BMD predicts fracture risk better than clini-cal risk factors or BMD alone. Use of FRAX withoutBMD is appropriate when BMD is not readily availableor to identify individuals who may benefit from a BMDmeasurement.

� It is not appropriate to use FRAX to monitor treatment re-sponse.

� Evidence that rate of bone loss may be an independentrisk factor for fracture is conflicting. Therefore, rate ofbone loss is not included as a FRAX risk factor.

� The generation of the FRAX score during DXA scanfor untreated subjects is recommended where appro-priate.

TableClassification of Countries Within Asia-Pacific Region

Category of riska Sim

Very high Taiwanb

High Hong Kongb, Singaporeb

Medium Australiab, Japanb, Korea Republicb, MalaysLow China Mainlandb, Indiab, Indonesiab, PakistaUndetermined Bangladesh, Bhutan, Brunei Darussalam, Ca

Union of Myanmar, Papua New Guinea

aThe category of risk is summarized from the International Osteopoaged 50 yr and older (1).

bWith country-specific FRAX algorithm.

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FRAX: International Statements

Even given the frequent updates of FRAX� (4), thecountry-specific models will not be able to satisfy all thecountry/ethnicity needs worldwide. More than 130 countriesremain without its own FRAX� model to assess the osteopo-rotic fracture risk. In the absence of a FRAX� model for a par-ticular country/ethnicity, it has been suggested to usea surrogate country/ethnicity for which the epidemiology ofosteoporosis or public health most closely approximates theindex country (8). Therefore, the International Task Forcesynthesized the data regarding geographic or ethnicity differ-ences in osteoporosis or fracture and summarized the state-ments about use of FRAX� in North American and Globalregions (8).

Of the 25 countries, only 12 countries or regions have de-veloped country-specific or ethnic-specific FRAX� model inAP region (4). Many countries in AP region still have no na-tional data on fracture incidence to formulate new FRAXmodels (15). The experts agree with all the International state-ments and adopt the recent published review by Kanis et al(1) to categorize the 25 countries of AP region into 4 sub-groups (very high, high, low, and undetermined) of fracturerisk (Table 1). In that, Taiwan stands for the only one countrywith ‘‘very high’’ risk of osteoporotic fracture. This classifica-tion provides an important reference for choosing a surrogatemodel in a country without country-specific FRAX model.The consensus was listed as follows:

� Separate FRAX models are available for United States(US) Asians, Blacks and Hispanics because hip and majorosteoporotic fracture rates are lower in these ethnicgroups than in US Whites. Until additional data are avail-able, the US Caucasian FRAX calculator should be usedto assess fracture risk in US Native American women.

� Changing fracture and mortality rates and improved qual-ity of data are expected. Therefore, periodic review ofcountry-specific fracture rates used in the FRAX modelis recommended.

� There is significant variability in hip fracture ratesthroughout the world. The minimum requirement forconstruction of a country-specific FRAX model is hip

1s According to the Population Risk of Hip Fracture

ilar region/country

ia, New Zealandb, Thailandb

n, Philippinesb, Sri Lankab, Vietnammbodia, Laos, Korea DPR, New Caledonia, Republic of The

rosis Foundation and country-specific representative data of women

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fracture incidence data that are of high quality and repre-sentative of that country.

� The accuracy of FRAX models is improved by the inclu-sion of country-, age- and sex-specific rates of other ma-jor osteoporotic fractures (clinical vertebral, humerus,distal forearm).

� In the absence of high quality, national hip fracture data,a country-specific FRAX model can be built using hipfracture incidence rates from a surrogate country, butwith incorporation of country-specific mortality rates.

� In the absence of any hip fracture data, development ofFRAX models based on broad categories of fracturerisk (e.g., low, medium, high), adjusted for country-specific mortality rates is recommended.

� The classification of countries within AP Regions accord-ing to the population risk of hip fracture is recommended(Table 1).

FRAX: Interventional Threshold

FRAX can be used as a component of guidelines forcountry-specific fracture risk thresholds at which it is likelyto be cost-effective to initiate pharmacological therapy to re-duce fracture risk (2e4,18). The 20% of 10-yr major fractureprobability and 10% in hip fracture recommended by NOFwere the 2 most commonly used thresholds in clinical prac-tice or guideline (3). However, the health system and publicpolicy are not compatible between the countries that might in-fluence the application of the FRAX threshold worldwide.The new joint IOF/ISCD official positions (13) did not dis-cuss a universal intervention threshold, as it is a complexissue, which should be determined in a country-specific man-ner. For clinical practice, the FRAX score is always expectedto be as an intervention threshold. Therefore, in the consensusmeeting, the experts addressed this issue and summarized therecommendations to guide the decision of interventionalthreshold in AP region as follows:

� FRAX is used for identification of untreated subjects athigh risk of fractures.

� The FRAX tool does not make recommendation abouttherapeutic intervention.

� Intervention thresholds may vary among countries, evenin the same risk classification.

� The strategy of clinical intervention is best determined byclinicians based on a patient-centered approach.

In conclusion, a consensus of Official Positions of the JointOfficial Positions of ISCD and IOF on FRAX by the AP Panelof ISCD has been presented in this current review, consider-ing the different population characteristics and health stan-dards in the AP region. We hope that these reviewedposition statements can help meet the unique concerns inAP regions and help the promotion of FRAX worldwide.

Acknowledgments

The authors acknowledge the extraordinary efforts of theIOF/ISCD PDC Task Force Chairpersons and members,

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who represented a distinguished group of international ex-perts. Financial support for the meeting was received in theform of educational grants from TOA, IOF, ISCD, Eli-Lilly& Company, Servier, GlaxoSmithKline, GE Healthcare, andTaiwan MICE International Meetings Hosting Project. Theselection of PDC topics, participants, or development of theconsensus was independently made by the experts and APPanels of ISCD. The AP consensus statement of official posi-tions are endorsed by ISCD.

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Appendix

Consensus Meeting Members

Organizers: Chih-Hsing (Paulo) Wu (Chair), Rong-SenYang (Co-Chair).

Moderators: Keh-Sung Tsai, Poon-Ung Chieng, Sheng-PinChanglai, Jung-Fu Chen, Ding-Cheng Chan.

Experts: Eugene V. McCloskey, Joon Kiong Lee, AkiraItabashi, Richard Prince, Wei Yu, Julie Li-Yu, Siok BeeChionh, Yanling Zhao, Chan Soo Shin, Tirtarahardja Guna-wan, S. Bobo Tanner, Chao-Jan Wang, Zih-Jie Sun, Yin-FanChang.

DXA Company Representatives: Amy Hsieh, Issac T.T.Lin, Jim Tsai, Albert L.S. Yang, Qi Zhou, Thomas V. San-chez.

Invited Reviewers: Didier B. Hans, John A. Kanis.Supporting Person: Christine Lee.

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