|Year : 2019 | Volume
| Issue : 6 | Page : 1824-1827
Utility of FRAX (fracture risk assessment tool) in primary care and family practice setting in India
Kripa Elizabeth Cherian, Nitin Kapoor, Thomas Vizhalil Paul
Department of Endocrinology, Christian Medical College and Hospital, Vellore, Tamil Nadu, India
|Date of Submission||12-May-2019|
|Date of Decision||13-May-2019|
|Date of Acceptance||22-May-2019|
|Date of Web Publication||26-Jun-2019|
Dr. Thomas Vizhalil Paul
Department of Endocrinology, Christian Medical College and Hospital, Vellore, Tamil Nadu
Source of Support: None, Conflict of Interest: None
The prevalence of osteoporosis in postmenopausal women is about 35 to 50% and the mortality associated with hip fractures is about 20%. Despite these figures, osteoporosis continues to be under diagnosed in the primary care setting. One of the reasons for this is attributed to the poor availability of DXA (Dual Energy X-ray Absorptiometry) scanners in rural areas. The fracture risk assessment tool (FRAX) is an online web-based tool that takes into account multiple factors that help in predicting the 10-year risk of developing hip or major osteoporotic fractures. The tool was developed and validated in independent cohorts. The advantages of using the FRAX tool are that, it is inexpensive, easily available, and does not need the technical expertise that is required in the use of a DXA scanner. Besides these merits, it is a tool that is easy to use for the rural health care worker as well as the family physician in identifying those subjects at risk for developing osteoporotic fractures. These benefits make it a suitable fracture prediction tool in the primary care setting in India.
Keywords: Frax, India, osteoporosis, primary Care
|How to cite this article:|
Cherian KE, Kapoor N, Paul TV. Utility of FRAX (fracture risk assessment tool) in primary care and family practice setting in India. J Family Med Prim Care 2019;8:1824-7
|How to cite this URL:|
Cherian KE, Kapoor N, Paul TV. Utility of FRAX (fracture risk assessment tool) in primary care and family practice setting in India. J Family Med Prim Care [serial online] 2019 [cited 2020 Aug 10];8:1824-7. Available from: http://www.jfmpc.com/text.asp?2019/8/6/1824/261440
| Introduction|| |
Despite the availability of various treatment modalities for prevention of osteoporotic fractures, their incidence is on the rise, mainly owing to the increased life expectancy of the world population. The treatment of osteoporosis is aimed at preventing the occurrence of fragility fractures, which pose significant economic burden and lead to a loss of independence, increased morbidity, and a high risk of mortality. The prevalence of osteoporosis in postmenopausal women has been reported to 35 to 50% in Indian studies and the mortality after 1 year of sustaining a hip fracture is about 20 to 30%., Osteoporosis continues to be under-diagnosed among those at risk (e.g., postmenopausal women and elderly men) and unfortunately, many remain untreated even after having sustained a fragility fracture. The reasons cited for this include less awareness among primary care and family physicians about the need for referral and treatment, limited access to an ideal diagnostic modality like dual-energy X-ray absorptiometry (DXA) scan, and lack of precise fracture risk prediction tools.,
Although osteoporosis is defined by low bone mineral density (BMD), its clinical significance depends on the occurrence of fractures following low-velocity trauma. Besides low BMD, there are several other causes, which predispose to fractures like increased propensity to falls, lifestyle factors including smoking and alcohol consumption, systemic disorders, and medications, especially glucocorticoids. It was realized that the estimation of fracture risk should incorporate additional parameters (risk factors for fragility fractures) in its assessment.
Although DXA scan has been realized to be the “gold standard” in diagnosing osteoporosis, its widespread availability is limited in a developing country like India. This problem assumes greater proportions in rural settings especially in primary care and family practice settings. An ideal screening tool for assessing osteoporotic fracture risk should be widely available, inexpensive and easy to use, and make therapeutic decisions from the perspective of family practice. These characteristics will offset the constraints posed by the high costs and limited availability of a DXA scanner. Thus, an ideal tool to assess osteoporotic fracture risk in a developing country like India may depend on the composite assessment of multiple risk factors that increase the propensity to fracture. The Fracture Risk Assessment Tool (FRAX) is a web-based internationally validated tool, which has been developed to assess fracture risk of patients based on various risk factors.
| Development of Frax Tool|| |
The World Health Organization (WHO) collaborating Center at Sheffield analyzed different potential risk factors from 60,000 men and women belonging to 12 prospective cohorts recruited from the general population. The cohorts included the subjects from the Rotterdam study in the Netherlands, the European Vertebral Osteoporosis Study (EVOS) from 13 centers in Europe, the Canadian Multicentre Osteoporosis Study (CaMos) and cohorts from Rochester (USA), Sheffield (England), the Dubbo Osteoporosis Epidemiology Study (DOES, Australia), the Epidémiologie de l'ostéoporose (EPIDOS) and Os des Femmes de Lyon (OFELY) studies (France), as well as those from Kuopio (Finland), Hiroshima (Japan), and two from Gothenburg (Sweden). The total follow-up was over 250,000 person-years. The following risk factors were chosen, based on whether they would be amenable to pharmacological intervention:
- Bone mineral density
- Body mass index (BMI)
- Prior fragility fracture
- Use of oral glucocorticoids
- Parental history of fracture
- Current smoking
- Alcohol intake
- Rheumatoid arthritis.
Four models were then constructed from the risk factor analysis. Fracture probabilities were computed. These included the probability of hip fracture and other major osteoporotic fractures (with and without BMD). Fracture and death as continuous hazard were estimated using a Poisson regression.
The performance characteristics of these risk factors gave birth to “FRAX tool,” which is widely used to predict the 10-year probability of hip fracture or major osteoporotic fracture (hip, spine, distal forearm, and proximal humerus),.
| Validation of Frax Tool|| |
The validation of FRAX was subsequently done in other independent cohorts that did not participate in the original model preparation. Some of these cohorts included the Study of Osteoporotic Fractures (SOF) in the United States, two cohorts from the Geelong study in Australia, the Osteoporosis Ultrasound Study (OPUS) drawn from five European countries, the Prospective Epidemiological Risk Factors Study (PERF) from Denmark, the York cohort in the United Kingdom, the Health Improvement Network (THIN) research database from the United Kingdom, the Swiss Evaluation of Measurement of Osteoporotic Fracture Risk (SEMOF) study in Switzerland, the Women's Health Initiative (WHI) from the United States, and the Miyama cohort from Japan.
The usage of FRAX in initiating treatment for osteoporosis varies from country to country. In the UK, women with a previous fragility fracture are eligible for anti-osteoporotic treatment without doing FRAX or BMD. However, those without a past history of a fragility fracture would be treated if they met the age specific cut-off for their FRAX score as set up by NOGG (National Osteoporosis Guideline Group). If their threshold of FRAX is in the lowest category, then they do not warrant any further assessment or therapeutic intervention. BMD is performed only in those who have no previous history of fragility fracture and belong to the intermediate risk category as per their FRAX score.
However, in the United States, FRAX is only done in women who have their BMD in the osteopenic range (T-Score between -1 and -2.5 SD) and are offered treatment in those with a 10-year probability of major osteoporotic fractures equal to or exceeding 20%, or when 10-year probability of hip fracture exceeds 3%.
As the FRAX tool was validated mostly in cohorts from a Caucasian ethnicity, its use in other countries may require revised cut-offs for therapeutic decision making and follow-up for the occurrence of incident fractures.,
Till date, the FRAX tool is the most widely used fracture risk assessment tool throughout the world. It is presently used in many countries comprising about 80% of the world population. The main objective of using the FRAX tool is to enable medical professionals especially in family practice and in primary care setting to identify those patients who would benefit from pharmacological therapy in reducing fracture risk. However, like any other scientific tool, FRAX is beset with merits and limitations, as outlined below.
| Merits of Using the Frax Tool|| |
The major benefit of FRAX includes its extensive data driven origin from multiple cohorts and its further validation in different populations. It has also been integrated as part of the National Osteoporosis Foundation (NOF) guidelines and therapeutic decisions for management of osteoporosis could now be based on the FRAX score of an individual. The FRAX model is further calibrated by local epidemiological studies to generate region specific risks in different populations. The currently available version is available in 34 languages and applicable to 64 countries.
| Limitations of the Frax Tool|| |
Although FRAX can be utilized to predict fracture risk using both clinical risk factors and bone mineral density in a global setting, it has certain limitations. The first and the most cited limitation of FRAX is that it does not encompass all the important factors that may predict fracture risk in a given individual like physical activity, vitamin D deficiency, likelihood of fall assessment, bone turnover markers, or the rate of bone loss on sequential BMDs.
Relevance of FRAX in the primary care and family practice settings in India
The major brunt of osteoporosis and its fracture-related complications are borne by postmenopausal women. There are more than 100 million postmenopausal women in India, and more than two-thirds of them reside in rural areas., Therefore, primary care physicians and family care practitioners play an important role in pre-emptively screening them for fracture risk. As the availability of DXA scanners is limited in resource poor conditions, FRAX may be utilized to identify those at risk for osteoporotic fractures. In a recent study by Asirvatham et al., out of a total of 239 patients, 207 had identical fracture risk predictions utilizing FRAX, with and without BMD. Thus, FRAX proves to be an inexpensive tool to make fracture risk predictions, where availability of DXA is restricted. Also, the use of DXA scanners requires suitable technical expertise for their standardization and calibration as well as for accurate positioning of skeletal regions of interest. The costs involved in performing a DXA scan is often prohibitive; this further substantiates the utilization of FRAX in the primary care setting. The easy availability of this simple online tool makes it possible for primary health-care workers especially in the rural setting as well as family medicine physicians to objectively identify subjects at risk for osteoporotic fractures. Initiation of treatment in at-risk subjects as identified by the FRAX tool, also endorses good health economics as it is more cost-effective to prevent rather than to treat osteoporotic fractures especially at hip.
In conclusion, FRAX tool has been shown to have good utility in the management of osteoporosis in many nations. Hence, primary care and family physicians across the country need to avail themselves of this widely available and user friendly tool to assess the fracture risk secondary to osteoporosis and plan therapeutic decisions in Indian postmenopausal women.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Mithal A, Bansal B, Kyer CS, Ebeling P. The Asia-pacific regional audit-epidemiology, costs, and burden of osteoporosis in India 2013: A report of International Osteoporosis Foundation. Indian J Endocrinol Metab 2014;18:449-54.
Paul TV, Selvan SA, Asha HS, Thomas N, Venkatesh K, Oommen AT, et al
. Hypovitaminosis D and other risk factors of femoral neck fracture in South Indian postmenopausal women: A pilot study. J Clin Diagn Res 2015;9:OC19-22.
Khadilkar AV, Mandlik RM. Epidemiology and treatment of osteoporosis in women: An Indian perspective. Int J Womens Health 2015;7:841-50.
Thakur P, Kuriakose C, Cherian KE, Asha HS, Kapoor N, Paul TV. Knowledge gap regarding osteoporosis among medical professionals in Southern India. J Eval Clin Pract 2019. doi: 10.1111/jep.13164.
Salminen H, Piispanen P, Toth-Pal E. Primary care physicians' views on osteoporosis management: A qualitative study. Arch Osteoporos 2019;14:48.
Bledsoe L, Alessi K, Toro JB, Giordano B, Hanypsiak BT. Fragility fractures: Diagnosis and treatment. Am J Orthop 2018;47. doi: 10.12788/ajo. 2018.0112.
Varthakavi PK, Joshi AS, Bhagwat NM, Chadha MD. Osteoporosis treatment in India: Call for action. Indian J Endocrinol Metab 2014;18:441-2.
Siris ES, Baim S, Nattiv A. Primary care use of FRAX: Absolute fracture risk assessment in postmenopausal women and older men. Postgrad Med 2010;122:82-90.
Kanis JA, Johansson H, Harvey NC, McCloskey EV. A brief history of FRAX. Arch Osteoporos 2018;13:118.
Kanis JA, Harvey NC, Johansson H, Odén A, Leslie WD, McCloskey EV. FRAX and fracture prediction without bone mineral density. Climacteric 2015;18(Suppl 2):2-9.
Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 2008;19:385-97.
Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A. How to decide who to treat. Best Pract Res Clin Rheumatol 2009;23:711-26.
Cherian KE, Kapoor N, Shetty S, Naik D, Thomas N, Paul TV. Evaluation of different screening tools for predicting femoral neck osteoporosis in rural South Indian postmenopausal women. J Clin Densitom 2018;21:119-24.
Bansal B, Mithal A, Chopra SR, Bhanot S, Kuchay MS, Farooqui KJ. Judicious use of DXA-BMD in assessing fracture risk by using clinical risk factors in the Indian population. Arch Osteoporos 2018;13:115.
Kanis JA, McCloskey EV, Johansson H, Oden A, Ström O, Borgström F. Development and use of FRAX in osteoporosis. Osteoporos Int 2010;21(Suppl 2):S407-13.
Kanis JA, Johansson H, Oden A, Cooper C, McCloskey EV; Epidemiology and Quality of Life Working Group of IOF. Worldwide uptake of FRAX. Arch Osteoporos 2014;9:166.
McClung MR. To FRAX or not to FRAX. J Bone Miner Res Off J Am Soc Bone Miner Res 2012;27:1240-2.
Kanis JA, Harvey NC, Cooper C, Johansson H, Odén A, McCloskey EV, et al
. A systematic review of intervention thresholds based on FRAX: A report prepared for the National Osteoporosis Guideline Group and the International Osteoporosis Foundation. Arch Osteoporos 2016;11:25.
Compston J. FRAX--Where are we now? Maturitas 2015;82:284-7.
Kanis JA, Oden A, Johansson H, Borgström F, Ström O, McCloskey E. FRAX and its applications to clinical practice. Bone 2009;44:734-43.
Asirvatham AR, Balachandran K, Kannan S, Balasubramaniam SK, Mahadevan S. FRAX first-Pragmatic approach in resource poor settings. Indian J Endocrinol Metab 2018;22:757-9.
Gadam RK, Schlauch K, Izuora KE. FRAX prediction without BMD for assessment of osteoporotic fracture risk. Endocr Pract 2013;19:780-4.
Marques A, Lourenço Ó, Ortsäter G, Borgström F, Kanis JA, da Silva JA. Cost-effectiveness of intervention thresholds for the treatment of osteoporosis based on FRAX(®) in Portugal. Calcif Tissue Int 2016;99:131-41.