1 Appraisal Committee's preliminary recommendations
1.1 Bisphosphonates (alendronate, etidronate and risedronate) are recommended as treatment options for the prevention of osteoporotic fractures in postmenopausal women aged 65 years and older who have experienced a fragility fracture 1 without need for dual energy X-ray absorptiometry (DEXA) scanning.
1 For fragility fracture definition, see Section 2.7
1.2 Bisphosphonates are recommended as treatment options for postmenopausal women younger than 65 years of age with a fragility fracture if they have either of the following:
T-score2 below -3.2 SD established by a DEXA scan
T-score below -2.5 SD and either a history of maternal hip fracture or long-term use of systemic corticosteroids.
2 For T-score definition, see Section 2.3 and 2.4
1.3 Bisphosphonates are not recommended for the treatment of osteoporosis in postmenopausal women of any age who do not have a fragility fracture.
1.4 Teriparatide is only recommended as an option for the treatment of osteoporosis in postmenopausal women aged 70 years and older who have multiple fragility fractures, if they have had an inadequate clinical response to bisphosphonates and a very high fracture risk, defined as one of the following:
T-score below -4.0 SD, established by a DEXA scan
T-score below -3.2 SD and either a history of maternal hip fracture or long-term use of systemic corticosteroid
1.5 Before bisphosphonates or teriparatide are prescribed, it should be established that the woman has adequate levels of calcium and vitamin D, and dietary supplements should be prescribed or advised if levels are below normal.
1.6 Raloxifene is not recommended for the treatment of osteoporosis in postmenopausal women.
2 Clinical need and practice
2.1 Osteoporosis is defined as a progressive, systemic skeletal disorder characterised by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.
2.2 Bone formation exceeds bone resorption in youth, but by the third decade of life there is a gradual loss of bone mass. Therefore, primary osteoporosis is usually an age-related disease. It can affect both sexes, but women are at greater risk because bone loss is accelerated, to varying degrees, after the menopause because of loss of oestrogen production.
2.3 The World Health Organization's classification of osteoporosis has been widely adopted and is based on the measurement of bone mineral density (BMD), with reference to the number of standard deviations (SD) from the BMD in an average 25-year-old woman (T-score):
normal: T-score of -1 SD or more
osteopenia: T-score between -1 and -2.5 SD
osteoporosis: T-score below -2.5 SD
established/severe osteoporosis: T-score below -2.5 SD, with one or more associated fractures.
2.4 BMD T-scores can vary by site and method of measurement. A reference standard has therefore been adopted of measurement at the femoral neck using DEXA.
2.5 It is estimated that there are 2.1 million women with osteoporosis (that is, BMD T-score below -2.5 SD) in England and Wales. Prevalence increases markedly with age after menopause and approximately 50% of women aged 80 years and older are estimated to have the condition.
2.6 Risk factors for osteoporosis include smoking, low body mass index, early menopause, family history of osteoporosis, long-term systemic corticosteroid use and conditions affecting bone metabolism. It is most common in white women.
2.7 Fragility fracture is the clinically apparent and relevant (adverse) outcome in osteoporosis. Fragility fractures are fractures that result from low-level trauma, which means mechanical forces that would not ordinarily cause fracture. The World Health Organization has quantified this as forces equivalent to a fall from a standing height or less. In the absence of fragility fracture, the condition is asymptomatic and often remains undiagnosed.
2.8 Fragility fractures occur most commonly in the vertebrae, hips and wrists, and are associated with substantial disability, pain and reduced quality of life. It is estimated that there are 180,000 osteoporosis-related symptomatic fractures annually in England and Wales. Of these, 70,000 are hip, 25,000 are vertebral, and 41,000 are wrist fractures. As with osteoporosis, the incidence of osteoporosis-related fractures rises with age in postmenopausal women. In 2000, it was estimated that the total cost of treating osteoporosis-related fractures in postmenopausal women was between £1.5 and £1.8 billion. This is expected to increase to £2.1 billion by 2010.
2.9 In women older than 50 years of age, the lifetime risk of vertebral fracture is estimated to be about one in three, and approximately one in six for hip fracture. Postmenopausal women with an initial fracture are at much greater risk of subsequent fractures.
2.10 After treatment for hip fracture many women are unable to walk independently and perform other activities of daily living, and so are unable to continue to live independently. Hip fractures are also associated with increased mortality. In the 12 months after hip fracture, estimates of the relative mortality risk vary from two to more than ten, depending on age. However, it is unclear to what extent this can be independently attributed to fracture.
2.11 Vertebral fractures are associated with loss of height and curvature of the spine. They result in pain, breathing difficulties and gastrointestinal (GI) problems, and difficulties with activities of daily living. Many vertebral fractures (50-70%) may not come to clinical attention. Vertebral fractures are also associated with increased mortality. Estimates of the age-standardised relative mortality risk in the 12 months after vertebral fracture range from two to nine.
2.12 The Royal College of Physicians' guidelines on the treatment of osteoporosis and the National Service Framework for Older People recommend a selective case-finding approach, the use of BMD measurement, and drug treatment focused on women with fractures or multiple risk factors.
2.13 A number of interventions are used to prevent and treat osteoporosis. Lifestyle modifications include regular weight-bearing exercise, smoking avoidance, and moderation of alcohol intake. In older patients, fall prevention measures, such as home modifications, and hip protectors may also be considered. Drug therapies and supplements include hormone replacement therapy (HRT), bisphosphonates, selective oestrogen receptor modulators (SERMs), parathyroid hormone, calcitonin, calcium, vitamin D, and calcitriol. It is estimated that in the UK 10-20% of women with osteoporosis receive drug treatment for the condition. The choice of interventions is influenced by factors such as BMD, stage of disease progression, nature and site of fracture, patient age, underlying co-morbidities and side effects.
2.14 Acute management of osteoporotic fractures may include pain relief, physiotherapy and appropriate orthopaedic management. Surgery is required for most hip fractures, but for vertebral fractures surgery is generally reserved for cases involving neurological deficit or spinal instability.
Note: Note that these are still recommendations by NICE and have not been formalised as guidelines yet.