Clinical Practice Guidelines on Postmenopausal Osteoporosis: *An Executive Summary and Recommendations – Update 2019–2020

Review on Vitamin D: Michael F. Holick, Professor of Medicine, Physiology and Biophysics and Molecular Medicine. Director, Vitamin D, Skin, and Bone Research Laboratory. Programme Director General Clinical Research Unit. Director, Biologic Effects of Light Research Centre, Director, Bone Healthcare, Boston.

External Review Board: A Muruganathan, Anil K. Jain, Dinesh K. Dhanwal, G. R. Sridhar, Hema Divakar, K. V. Radha Krishna, Prof. Nihal Thomas, N. S. Neki, P. K. Shah, S. K. S. Marya, Sandhya Kamath, Sarita Bajaj, Thomas Paul, Vishal Tandon.

Advisory Board: Asha Kapadia, Atul Munshi, Duru Shah, Rama Vaidya, Saroj Srivastava, Sonia Malik, Sunila Khandelwal, Urvashi Prasad Jha.

Resource Faculty: Alap Shah, Amita Pandey, Anil Mahajan, Ashok Vaidya, Beena Bansal, Bharti Kalra Prof. Dr. C. V. Harinarayan, Dilip Mehta, Hemant Tiwari, I. V. Reddy, Jyothi Unni, Ketan Mehta, Manisha Sahay, Meeta Meeta, Nagamani, Neelam Agarwal, Rabindera Nath Mehrotra, Raghava Dutt Mulukutla, Rakesh Sahay, Major General (Dr.) Raman Kumar Marwaha, Ram Prabhoo, Rama Vaidya, Ranu Patni, Rashmi Shah, Sanjay Bhadada, Sanjay Kalra, Sailesh B., Seema Puri, Sharad Kumar, Shashank Joshi, Shushrut Babhulkar, Siddharth Sarkar, Sudha Sharma, Sunila Khandelwal, Sushil Gupta, Vishal R. Tandon, Vivek Arya, U. R. K. Rao, Yatan Pal Singh Balhara.

*This is a short summary and recommendations from the detailed monogram on clinical practice guidelines on postmenopausal osteoporosis available at the Indian Menopause Society Website: www. indianmenopausesociety.org.

Received 2020 Jun 27; Revised 2020 Jul 10; Accepted 2020 Jul 19. Copyright : © 2020 Journal of Mid-life Health

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

See commentary "Commentary on Indian Menopause Society Guidelines" in volume 11 on page 115.

I NTRODUCTION

Among the several challenges faced by the growing elderly population with increasing longevity in India, postmenopausal osteoporosis (PMO) is emerging as one of the major public health issues. Osteoporosis is an asymptomatic or “silent” disease and generally presents as a fragility fracture. Typical osteoporotic fractures are those of the hip, spine, and wrist. Global data indicate that 20% of women with hip fracture die within 1 year of the fracture and 50% of them never regain their functional independence.[1] Vertebral fractures can also have significant mortality and are associated with increased long-term morbidity.[2] The World Health Organization (WHO) has identified osteoporosis as an important noncommunicable disease. Osteoporotic fractures impose great financial, medical, and social burden on society. These guidelines are intended to be used as a resource document by the healthcare providers involved in postmenopausal women's health at all levels of healthcare with specific reference to India. Although framed for India, it is hoped that these guidelines will be useful for menopause practitioners across the globe.

This is one of the endeavors of the Indian Menopause Society to work toward the slogan, “Fit @ Forty Strong @ Sixty, and Independent @ Eighty”.

B ASIC C ONCEPTS

Definitions

1. Osteoporosis: The WHO defines osteoporosis as “a systemic skeletal disease characterized by low bone mass (measured as bone mineral density [BMD]) and micro-architectural deterioration of the bone tissue with a consequent increase in bone fragility and susceptibility to fractures, involving the wrist, spine, hip, pelvis, ribs, or humerus”[3]

2. Fragility fracture, the end point of inadequate skeletomuscular health, has been defined by the WHO as “a fracture caused by injury, which would be insufficient to fracture normal bone: the result of reduced compressive and/or torsional strength of bone.” Clinically, a fragility fracture can be defined as one which occurs as a result of minimal trauma, such as a fall from a standing height or less, or no identifiable trauma[4]

3. The most common sites of fragility fracture are the hip, spine, and forearm. The other sites are pelvis, proximal femur, proximal humerus, proximal tibia, and fractures involving three ribs simultaneously[5]

4. Sarcopenia is a progressive and generalized skeletal muscle disorder that is associated with increased likelihood of adverse outcomes, including falls, fractures, physical disability, and mortality. Severe sarcopenia is confirmed by the presence of low muscle quantity or quality and/or low physical performance. Sarcopenia is diagnosed in the presence of low muscle quantity or quality. Low muscle strength indicates the probability of sarcopenia[6]

5. Frailty: Physical frailty is defined as “a medical syndrome with multiple causes and contributors that is characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death.”[7]

C RITERIA FOR D IAGNOSIS OF O STEOPOROSIS

6. The diagnosis of an osteoporosis is by the presence of fragility fracture (clinical or radiological) and/or by BMD (T-score below or equal to −2.5) in a postmenopausal woman [ Table 1 ]

Table 1

Diagnosis of osteoporosis

GradingScore
NormalT-score above (i.e., better than) −1.0
Osteopenia or low bone massT-score between −1.0 and −2.5
OsteoporosisT-score below (i.e., worse than) or equal to −2.5
Severe osteoporosisT-score below −2.5 with fragility fracture

7. The “gold standard” method of BMD testing is by dual X-ray absorptiometry (DXA). Its value is expressed in standard deviation (SD) units from the population mean in young adults (T-score) or from the mean in an age-matched population (Z-score)

8. The reference range recommended by the International Osteoporosis Foundation, International Society of Clinical Densitometry (ISCD), WHO, and National Osteoporosis Foundation (NOF) for calculating the T-score in the postmenopausal women is the National Health and Nutrition Examination Survey III reference database in Caucasian women aged 20–29 years (Grade C)[8,9,10,11]

9. The ISCD diagnostic criteria for osteoporosis in postmenopausal women and in men aged 50 and older is if the T-score of the lumbar spine, total hip, or femoral neck is −2.5 or less. In certain circumstances, the 33% of radius (also called 1/3 radius) may be utilized[12]

10. The Z-score describes the number of SDs by which the BMD in an individual differs from the mean value expected for age and sex. It is mostly used in children, adolescents, and premenopausal women. A Z-score below −2 is regarded as abnormal and should be referred to as “low for age.” A low Z-score in a postmenopausal woman indicates the need to evaluate for secondary osteoporosis.[12]

T YPES OF O STEOPOROSIS

11. Osteoporosis is classified as primary (includes type I and type II) and secondary

Primary osteoporosis is seen in the postmenopausal women in whom there is no specific pathogenetic mechanism other than age

Type I or PMO affects mainly trabecular bone occurring in the early part of the menopause transition. There is an accelerated bone loss at the rate of 1%–2% per year (range 1%–5% yearly) due to declining estrogen levels and is seen in the first 5–7 years after menopause[13]

Type II or senile osteoporosis is age related, and bone loss occurs at a rate of 1% per year in both sexes and affects the cortical and trabecular bone.

Secondary osteoporosis is due to specific causes.[14]

12. Osteoporosis and osteomalacia: Bone is a dynamic tissue with a continuous remodeling, leading to the formation of new bone and resorption of old bone. A mismatch of this process forms the basis for osteoporosis, while defective mineralization of the newly formed osteoid is called osteomalacia.[15]

E PIDEMIOLOGY

13. There is a wide prevalence of low dietary calcium in Indians of all age groups, with majority of postmenopausal women consuming

14. Studies on bone mineral health from different parts of India indicate a wide prevalence of Vitamin D deficiency in all age groups, including infancy, adulthood, postmenopausal women, pregnancy, and lactation[21,22,23,24,25,26,27,28,29,30,31]

P EAK B ONE M ASS

15. Peak bone mass (PBM) is the highest level of bone mass achieved as a result of normal growth and is important as it determines resistance or susceptibility to osteoporosis and fractures. PBM is the result of the interaction of the various factors: genetic, hormonal, racial, nutritional, lifestyle, and physical exercise.[32,33,34,35,36] Environmental factors modulate the expression of the genetic potential to achieve PBM[37,38]

16. Age, sex, and genetic predisposition are important nonmodifiable risk factors for osteoporosis

17. Although PBM is achieved by 25–30 years, 40%–50% of bone mass is achieved by the age of 18 years. At skeletal maturity, women have 10%–15% lower bone mass than men. Asian Indians have a significant lower PBM than Caucasians.[39,40,41]

S CREENING AND D IAGNOSIS

18. Osteoporosis is asymptomatic unless a fracture occurs. Fracture risk is defined by BMD (both primary and secondary causes) and clinical risk factors. For treatment purpose, combining BMD with clinical risk factors provides a better estimate of fracture risk. We simply should not treat T-scores but must take a patient's full clinical status into account when we make therapeutic decisions

19. Early diagnosis in the asymptomatic period is essential, and timely management of osteoporosis will prevent the associated morbidity and mortality. Osteoporotic fracture risk screening of large-scale whole population groups is not likely to be cost-effective, so more selective approaches, i.e., targeted screening for disease detection, are advocated. In the absence of a validated population screening tool for PMO in India, a case-finding strategy utilizing clinical risk factors with the addition of DXA as needed is suggested (Grade C)

20. Asymptomatic women: Opportunistic screening for women above 40 years is suggested [Flowchart 1 Refer Appendix 1]

21. Risk assessment factors for fractures are derived by history and clinical examination. It is important to distinguish between those risk factors that lead to reduced bone mass from those that predispose to osteoporotic fractures with a BMD not in the osteoporotic range. Risk assessment tools such as The Osteoporosis Self-Assessment Tool (OSTA)8788] for Asians and Simple Calculated Risk Estimation Score (SCORE)89 are simple and cost-effective to screen women at risk for osteoporotic fracture

22. The WHO Fracture Risk Assessment Tool (FRAX) is country specific, and an online tool is available for India (http: www.shef.ac.uk/FRAX). FRAX is used to identify patients in the osteopenia group most likely to benefit from treatment. It predicts the 10-year absolute risk for a fracture in an individual, and the cost-effective analysis determines the interventional threshold above which the treatment is cost-effective. FRAX is country specific, and until more Indian data are available on the prevalence of osteoporotic fractures and mortality rates, it may not serve the true purpose for the usage of FRAX in the Indian context (Grade C)

23. Major risk factors defined by the WHO are (Grade A):