COUNTRY OVERVIEW
India, with a population of 1.2 billion people, is the second largest emerging economy
and second most populated country in the world. Life expectancy is 67 years and is
expected to increase to 71 years by 2025 and to 77 years by 2050 [Figure 1].[1] Currently,
approximately 10% of India's population (more than 100 million) is aged over 50 years.
Based on current patterns of growth, India's population is expected to grow by 16%
to reach 1.4 billion by 2025. From 2025 to 2050 the population will increase by a
further 34%, reaching 1.88 billion [Figure 2].[1] Those above the age of 50 years
will constitute 22% of the population in 2025 and 33% of the population in 2050. With
estimates showing that approximately 80% of the urban Indian population is vitamin
D deficient[2] and hip fractures occur about a decade earlier than in Western nations[3],
osteoporosis is a major concern for this ageing population.
Figure 1
Life expectancy in India
Figure 2
Population projection for India until 2050
State of osteoporosis/osteopenia
In the 2009 International Osteoporosis Foundation (IOF) Asian Audit, expert groups
estimated that the number of osteoporosis patients in India was approximately 26 million
in 2003, with projections indicating that this would rise to 36 million patients by
2013.[4] Now, in 2013, sources estimate that 50 million people in India are either
osteoporotic (T-score lower than -2.5) or have low bone mass (T-score between -1.0
and -2.5).[5]
In a study among Indian women aged 30-60 years from low-income groups, bone mineral
density (BMD) at all skeletal sites was much lower than values reported from developed
countries, with a high prevalence of osteopenia (52%) and osteoporosis (29%), thought
to be due to inadequate nutrition.[6] In a more recent study from Delhi, 792 males
and 808 postmenopausal females with a mean age of 57.67 ± 9.46 years were evaluated.
Osteoporosis was present in 35.1% of subjects (M-24.6%, F-42.5%) and osteopenia in
49.5% (M-54.3%, F-44.9%).[7] Both of these studies used the manufacturer's White Caucasian
reference database.
In an attempt to generate an India-specific database, the Indian Council for Medical
Research (ICMR) carried out a large multicenter study, which confirmed data from smaller,
single-center studies, and showed that Indians have lower BMD than their North American
counterparts.[8] A study involving more than 3,500 subjects carried out at a tertiary
care center in South India to study the effect of the newly generated ICMR database
(ICMRD) on the diagnosis of osteoporosis reported that a greater proportion were diagnosed
as having osteoporosis with Hologic as compared to the ICMR database. Osteoporosis
at the spine and hip was present in 42.7% and 11.4% subjects using the Hologic database
and in 27.7% and 8.3% subjects using the ICMR database.[9]
Similarly in a study from North India where age-specified BMD reference ranges were
established in females between 18-85 years, the prevalence of osteoporosis among women
aged older than 50 yearswas significantly higher based on Caucasian T-scores as opposed
to using peak BMD/standard deviation values from the population under review at lumbar
spine. However, there was no major difference observed at femoral neck.[10]
Reasons ascribed for lower BMD in Indians include possible genetic differences, nutritional
deficiency, and smaller skeletal size.[11]
Lifestyle
Widespread vitamin D deficiency has been shown unequivocally across all ages throughout
India. More than 80% of urban Indians have serum 25(OH) D levels below 20 ng/mL. This
includes pregnant women and their newborns, children and adolescents, young adults,
and the elderly. Vitamin D deficiency during childhood and adolescence decreases peak
bone mass in adults and may increase the risk of developing osteoporosis.[11] Studies
indicate approximately 80-90% of hip fracture patients are vitamin D deficient.[12
13] The high rate of vitamin D deficiency may be due to several causes such as low
sun exposure, inadequate dietary vitamin D intake, lack of food fortification with
vitamin D, pigmented skin, environmental pollution, and traditional dress code.[4]
To combat the low levels of vitamin D a couple of states have recently initiated vitamin
D fortification of edible oil and milk fortification, which can be an effective means
of delivering vitamin D.[14]
Nutritionally, the Indian population consumes much lower amounts of calcium (300-500
mg/day) than the ideal daily intake.[15] Additionally, tea is a popular beverage consumed
by the Indian population; however, due to the high caffeine content, some studies
have suggested that it may be associated with a greater risk of hip fracture.[16]
As in other Asian countries, urbanization also appears to be associated with an increase
in prevalence of osteoporosis due to lifestyle changes, lower physical activity, increase
in indoor living, and lower sun exposure [Figure 3].[17
18]
Figure 3
Urban versus rural population in India
Glucocorticoids are taken on a long-term basis by an estimated 1% of the Indian adult
population, especially the elderly. This is a contributing factor to osteoporosis
in India.[19]
Expatriate Indians also show evidence of poorer bone health than their western counterparts.
Experts have found that women from India who have migrated to western countries are
at increased risk of accelerated age-related bone loss when compared to their counterparts
living in the same geographic region due to their darker skin, dressing habits, and
lower bone mass.[20]
Level of awareness
Awareness of osteoporosis is low in India with a number of small-scale surveys indicating
that in the urban population approximately 10-15% are familiar with the disease. However,
awareness varies widely according to the level of education and those with a family
history of the disease. One study reveals that Indians find information about osteoporosis
mostly through the television and radio (55%) when compared with family/friends, newspaper,
and doctors (approximately 20% each). Unfortunately, information from the media is
not always accurate, and with only 20% of information coming from physicians there
is a clear need for increased involvement of doctors in educating patients about osteoporosis.[21]
FRACTURE RATES
Hip fracture
Hospital-based studies suggest that hip fractures are common in India too.[22] A study
on expatriate Indians in Singapore showed that hip fracture rates in Indians are somewhat
lower than in the Chinese and higher than in Malays.[23] This study has been used
to develop the Fracture Risk Assessment Tool (FRAX) model for India. A recent study
from Rohtak district in North India shows an annual incidence rate of 163 and 121
per 100,000 per year in women and men, respectively, above the age of 55 years [Figure
4].[24] However, with the rapid increase in the ageing population, an exponential
rise is expected in the absolute numbers of fractures in the next decade.[1]
Figure 4
The age- and sex-specific hip fracture incidence in Rohtak district, North India during
2009
SOURCE Dhanwal D.K. et al. (2013) Incidence of hip fracture in Rohtak district, North
India
The female preponderance of hip fractures that is observed in western populations
is less striking in India.[3
24] In Caucasians, hip fractures are twice as common in women, whereas in India the
ratio of hip fractures in women to men is more in the order of 3:2.[24] Additionally,
it has been suggested that hip fractures occur at an earlier age in Indians in comparison
with western counterparts with the peak age for hip fractures in Indians occurring
in their 60s.[3] This may be a function of a shorter life span. Studies of osteoporotic,
postmenopausal women in India found that on average, 34% were aged below 60 years.[24]
The 1-year mortality after hip fractures is high at over 30% in the public hospital
setting.[24]
India does not have standardized criteria for the management and treatment of hip
fractures, and procedures vary by hospital setting. The Indian Society of Bone and
Mineral Research (ISBMR) estimate that 90% or more of hip fractures are managed surgically
in urban areas. While the average waiting time for hip surgery is less than one day
in private hospitals, Indians often wait over three days for hip surgery in public
hospitals where the majority of cases are seen. The proportion of patients undergoing
surgery in rural areas is likely to be much lower.
Other fragility fractures
In a large questionnaire-based study involving 14,271 subjects, population prevalence
of low trauma fractures at hip, spine, and wrist was 34.3/100,000.[25]
Vertebral fractures
Vertebral fractures are common in Indians, with 15-20% of older urban adults aged
over 50 years showing evidence of at least one vertebral fracture. The prevalence
of radiographic vertebral fractures in older adults in Delhi has been recently reported
to be 17.9% (18.8% male and 17.1% female); indicating that vertebral fracture prevalence
in India is similar to Western populations [Figure 5].[26]
Figure 5
Prevalence of vertebral fractures in males and females according to age strata
SOURCE Marwaha R.K. et al. (2012). The prevalence of and risk factors for radiographic
vertebral fractures in older Indian women and men: Delhi Vertebral Osteoporosis Study
COSTS OF FRACTURE
Costs vary according to town, bed type, and whether or not the hospital is governmental,
public, or private. In private hospitals, the total cost of hip surgery is between
Rs 150,000 to 250,000 (2,360-3,860 USD), and in public hospitals the cost is approximately
Rs 50,000 (772 USD) [Table 1]. Private hospitals generally report shorter bed days
of 5-6 days than public hospitals where the stay can often be 15 days.
Table 1
Hip fracture in India: Hospital costs, bed days, and surgically treated percentage
Fracture registries
There are no official fracture registries in India although there could possibly be
some at the hospital level.
Fracture liaison services
India does not have any coordinator-based models of care, otherwise known as fracture
liaison services (FLS) for secondary fracture prevention. However, at least two hospitals
in New Delhi are in the early stages of developing a FLS.
SPECIALISTS RESPONSIBLE FOR OSTEOPOROSIS
The general management of osteoporosis is by orthopaedists and endocrinologists, but
other specialities also manage patients, including family doctors, rheumatologists,
gynecologists, endocrinologists, geriatricians, rehabilitation specialists, and internal
medicine physicians.
There is little osteoporosis-related education at the medical undergraduate level.
However, osteoporosis is a recognized component of specialty training for endocrinologists.
Various aspects of osteoporosis are also a component of training for orthopaedic surgeons,
gynecologists, rheumatologists, and rehabilitation medicine physicians.
GOVERNMENT POLICIES
Osteoporosis as a documented national health priority
Osteoporosis is not a national health priority (NHP) in India. Of the NHPs, the one
that will most closely impact osteoporosis is the nutritional program aimed at school
children to provide vitamins and minerals including vitamin D and calcium. Although
not formally recognized in health programs, vitamin D deficiency is increasingly becoming
an important public-health issue, and there is a proposal currently under review for
musculoskeletal diseases to be a NHP.
Guidelines
The Indian guidelines on glucocorticoid-induced osteoporosis, ‘Indian Rheumatology
Association guidelines for management of glucocorticoid-induced osteoporosis (GIOP)’
were published in 2011 as collaboration between the Indian Rheumatology Association,
the Endocrine Society of India, and the Indian Society of Bone and Mineral Research.[27]
Postmenopausal Osteoporosis guidelines are in the process of development jointly by
the Endocrine Society of India and ISBMR and are expected to be released in late 2013.
There are numerous initiatives and programmes hosted by ISBMR, promoting osteoporosis
awareness and education, such as:
Education programmes and conferences for doctors
Research grants for young investigators awarded annually
Bone densitometry courses
Web-based education on osteoporosis
Printed educational material produced.
Additionally, there are numerous campaigns targeted toward health care providers:
Orthopaedic and gynecologic Initiative
IOF/International Society for Clinical Densitometry (ISCD) courses
Osteoporosis for students
National Bone Health Quiz for medical students organized every few years
Essay competition for nutritionists.
Audit and quality indicator systems in place
Audit and quality indicator systems are not in place in India.
TREATMENT (REIMBURSEMENT OF MEDICATION)
In general, patients pay for treatment directly out of pocket. Health care coverage
is limited to less than 10% of users. Those with health insurance (e.g. central government
employees, state insurance, or private coverage) are generally only reimbursed for
hospital-based services. Outpatient services, including diagnostics and medications,
are not commonly reimbursed. This is true for osteoporosis care as well with designated
first-line treatments such as bisphosphonates, vitamin D, and calcium, which are paid
for by the patients [Table 2]. In cases where reimbursement is available, it is based
on the doctor's prescription without any strict regulations. However, “cheaper” generic
medications are available and are usually preferred in public/government systems.
And, because only hospitalized patients are reimbursed by insurance companies, several
doctors prefer to infuse zoledronic acid in the hospital setting. For those who have
health care coverage, the chart below summarizes treatment coverage in India.
Table 2
Treatments available in India and reimbursement levels
DIAGNOSTICS
Most Indian women cannot afford dual-energy X-ray absorptiometry (DXA) due to the
costs involved.[28] Like medication treatments, reimbursement is also limited for
the diagnoses of osteoporosis. In general, DXA and ultrasound are not reimbursed,
and patients pay for scans out of pocket [Table 3]. There are approximately 0.26 DXA
machines per 1 million of the general population[29] and very few of these are based
at the government hospitals, a fact which further limits access. In the private centers
where DXA is available, there is no waiting time for DXA, but again a very small proportion
of the population is reimbursed through the private sector.
Table 3
Diagnostic access and costs in India
Due to the limited reimbursement for DXA and ultrasound, cost is a barrier to access.
In general, DXA costs 27-67 USD. Ultrasound has no waiting time and costs between
25-40 USD.
RECOMMENDATIONS
While there has been considerable progress in research and epidemiology of osteoporosis
in India since the last IOF Asian Audit in 2009, numerous gaps still exist. Some of
the high priority areas for action over the next 3 years are listed below.
Prevention
Fortification of food with vitamin D needs to be introduced as a universal government
program.
Greater emphasis is needed on attainment of peak bone mass/childhood adolescent bone
health by nutrition and life style measures. Intensive, sustained, awareness, and
intervention programs need to be initiated at the school level.
Treatment
Establishment of reliable, accurate hip fracture registries is urgently needed and
is a prerequisite to the improvement of hip fracture care and implementation of secondary
prevention strategies.
Introduction of fracture liaison services (FLS) will considerably help secondary fracture
prevention efforts.
Research
There is a need for multicenter, large-scale hip fracture incidence studies for which
attempts are being made by ISBMR. The validation of a FRAX tool specifically for India
would enable better use of diagnostic facilities and improve selection of patients
requiring treatment.