Abstract
Summary
Using the FRAX® model for India, thresholds for osteoporosis evaluation and treatment without bone mineral density measurement were derived and were validated in a cohort of 300 patients. We suggest the use of this newer age and ethnic-specific FRAX®-derived thresholds for management of osteoporosis in India.
Purpose
Our study aimed to formulate population-specific intervention thresholds for treatment of osteoporosis in India which can be used even without dual X-ray absorptiometry (DXA).
Methods
Using the FRAX® model for India, thresholds for different age groups for men and women were calculated without bone mineral density (BMD) measurement. The lower assessment threshold (LAT) was based on the 10-year probability of a major osteoporosis fracture (MOF) or hip fracture (HF) equivalent to patients without clinical risk factors. The intervention threshold (IT) was based on the 10-year probability equivalent to patients with fracture. The upper assessment threshold (UAT) was set at 1.2 times the IT. Probability-based thresholds for no intervention (LAT), treatment initiation (UAT) and BMD assessment (between LAT and UAT) were derived. The thresholds were validated in a cohort of 300 patients who were referred for BMD testing.
Results
Graphs for age, gender, BMI and ethnic-specific LAT, IT and UAT for MOF and HF are derived. In the validation cohort, BMD testing to initiate/defer treatment was required in only 32.3% patients. The intervention thresholds derived without BMD testing were valid in 98.7% patients. Use of National Osteoporosis Foundation (NOF) guidelines would have resulted in overtreatment in 56/300 (18.6%) patients.
Conclusion
We suggest the use of this newer age and ethnic-specific FRAX®-derived thresholds for management of osteoporosis. Adopting these cut-offs will ensure that those requiring osteoporosis treatment will not be denied of it just because of lack of a DXA machine and will also help avoid overtreatment.
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Data availability
Yes.
Code availability
Yes.
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Concepts: LN, NB, UMV, NA, HK; design: LN, NB, VN; definition of intellectual content: LN, NB, NA, HK; literature search: LN, NB, PVP, VN; clinical studies: LN, NB, UMV, PVP, AM, HK; data acquisition: LN, NB, UMV, PVP, AM; data analysis: LN, NB, PVP; statistical analysis: LN, NB; manuscript preparation: LN, NB, UMV, PVP, AM; manuscript editing: LN, NB, UMV, NA, VN, HK; manuscript review: LN, NB, UMV, PVP, AM, NA, VN, HK; guarantor: LN, NB, UMV
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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The research work was done when Lakshmi Nagendra was doing Senior Residency at the Department of Endocrinology, Amrita Institute of Medical Sciences, Cochin, Kerala, India.
Supplementary Information
Supplementary Fig. 1
Flowchart representing categorisation of the study cohort into 4 groups based on the application of intervention thresholds and the validation of risk categorisation after BMD measurement (PNG 56 kb)
Supplementary Fig. 2
Receiver operating characteristic (ROC) curve to study the ability of FRAX-MOF and FRAX-HF to predict fragility fractures. Area under the curve (AUC) for FRAX-MOF is 0.819 and for FRAX-HF is 0.757 (PNG 66 kb)
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Nagendra, L., Bhavani, N., Menon, V.U. et al. FRAX-based osteoporosis treatment guidelines for resource-poor settings in India. Arch Osteoporos 16, 69 (2021). https://doi.org/10.1007/s11657-021-00931-8
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DOI: https://doi.org/10.1007/s11657-021-00931-8