1.1 The need for a guideline

Osteoporosis affects both men and women. Its prevalence increases with age, and it is particularly common in postmenopausal women. One in three women and one in twelve men over the age of 50 will suffer an osteoporotic fracture, affecting around 200,000 women and 40,000 men in Scotland.¹ Given the increasingly sedentary lifestyle followed by many people, particularly children,² and an increasing elderly population,³ the number of men and women suffering an osteoporotic fracture is likely to grow.

The significance of osteoporosis lies in the increased risk of fracture as the disease progressively reduces bone mineral density (BMD). In Scotland there are over 20,000 cases of osteoporotic fractures annually. More than 20% of orthopaedic bed days are taken up by patients who have suffered hip fractures.

Figure 1: Presentations with low impact fracture

Figure 1 shows presentations with fracture (sustained in the absence of major trauma) in men and women over the age of 50 as a percentage of approximately 2,600 fracture events presenting over a two year period at a Scottish teaching hospital serving a catchment population of around 250,000 people.

There is a personal cost to each patient in addition to the £1.7 billion annual cost to the UK exchequer of treating osteoporotic fractures.⁴

Fifty per cent of hip fracture patients are no longer able to live independently and 20% die within 6 months. In addition there is the pain, deformity and disability associated with vertebral fracture.

It is difficult to tease out the risk factors for osteoporosis, falls, and fracture. Osteoporosis is itself a risk factor for fracture while, for example, a sedentary lifestyle contributes to osteoporosis risk and also to the risk of falling. The three are inextricably linked and this complicates the review of the evidence.

A wide range of diagnostic and monitoring tools are available to identify those at risk of, or suffering from, osteoporosis, and it is important to identify the most effective of these. Across Scotland there is significant variation in the availability of physicians with an interest in osteoporosis, in availability of diagnostic equipment, and in referral and treatment rates.¹ A guideline to inform the public, clinicians, and those who allocate funding within NHSScotland is required to minimise variation and provide an evidence base for commissioning services.

1.2 Remit of the guideline

This guideline explores the selection of patients for referral or further investigation and monitoring, and treatment options. The objective is to ensure the timely identification of those individuals at highest risk of osteoporosis, as well as those who already have the disease. Patients who have already suffered a low impact fracture, including those who have just been admitted to hospital with such a fracture, are at highest risk.^5,6

Women and men over 50 who present with fractures (that occur in the absence of major trauma, such as road traffic accidents) have a high prevalence of osteoporosis, which can be readily identified and treated either within an orthopaedic setting or by liaison between orthopaedic and other secondary or primary care services. NHS Quality Improvement Scotland (formerly CEPS) have funded an audit of existing models of care for the secondary prevention of osteoporotic fractures. This will report in 2004 and may inform future service development.

This guideline pays particular attention to the treatment options that can be used in these patients to reduce their increased risk of further fractures with the aim of achieving "secondary prevention of fracture". Further information on the specific management of hip fracture can be found in SIGN Guideline 56.⁷

Specifically excluded from the remit are population screening, primary prevention of osteoporosis, and osteoporosis in children or adolescents.

1.3 Definitions

A World Health Organisation (WHO) working group and consensus conference have defined osteoporosis as "A disease characterised by low bone mass and microarchitectural deterioration of bone tissue, leading to enhanced bone fragility and a consequent increase in fracture risk".⁸

Osteoporosis is a systemic skeletal disease and osteoporotic fractures can occur at any site, though the fractures classically associated with this disorder are those involving the thoracic and lumbar spine, distal radius, and proximal femur. The definition does not imply that all fractures at sites associated with osteoporosis are due to the disorder. The interaction between bone geometry and the dynamics of the fall or the traumatic event, happening in a given environment, are also important factors in causing fracture. These can happen independently of, or in association with, low bone density.

1.3.1 Bone mineral density (BMD)

The risk of falls and the resultant trauma are difficult to assess and predict. The WHO definition of osteoporosis therefore captures only the bone-specific estimate of fracture risk. This is best captured by bone mineral density. The WHO working group used this technique to stratify risk as follows:

This definition only applies to women. Recent reviews have suggested that applying the same definition to men, based on a male normative range, would have the same utility⁹ although this is not universally accepted.¹⁰

1.3.2 T-Scores and z-scores

Measurements of bone mineral density are often cited in terms of a T-score, which is the number of standard deviations by which the patient's BMD differs from the mean peak BMD for young normal subjects of the same gender. Another measure of BMD is the Z-score, which is the number of standard deviations by which the patient's BMD differs from the mean BMD for subjects of the same age

1.4 Patient concerns and how they influenced the guideline

Patient concerns regarding osteoporosis were identified through contact with patients themselves and via the published literature. A review of the literature highlighted issues that are of concern to people suffering from, or concerned about their risk of suffering from, osteoporosis. Similar concerns were also identified from calls received by the National Osteoporosis Society (NOS) helpline (managed by a team of osteoporosis nurse advisers). The concerns raised by patients are summarised below.

1.4.1 am i at risk of developing osteoporosis?

Lack of awareness of risk factors or lack of visibility of osteoporosis as a health problem means that women may not perceive themselves to be at risk of developing the disease.^{11,12,13,14,15}

Patients may be aware of the importance of some risk factors, such as family history, and seek out advice and treatment. Men tend to be less aware of the risk and what it implies for their health and lifestyle.

"I knew I was at risk of it because my mum and auntie both had... you know.. the hump back. ... am quite happy now on my HRT and I do plenty walking."

Risk factors are discussed in section 2

1.4.2 do I NEED a bone scan?

Patients are concerned that they do not have access to bone scans. Current provision in Scotland is variable.

Some patients report anxiety if they are not offered a repeat bone scan following treatment.

"It really helps to have a bone scan every now and then as I feel I am doing the right thing and carrying on with the treatment- my bones have not got any worse - I don't want to end up like my mother - she really suffered an awful lot of pain."

Bone densitometry is discussed in sections 3 and 6

1.4.3 what can i do to make things better for myself?

The majority of people with osteoporosis, if given appropriate information, are very keen to do what they can to influence their bone health and protect themselves from (further) fractures. This means not just taking medication but also having a calcium rich diet and being able to take regular exercise without the fear of having a fall and/or fracture.^16,17,18

"How much calcium should be taken? Do I take tablets, or rely on calcium rich foods?"

"I have been told not to have too much fat because of my heart problems - so what do I eat when I am not allowed too much cheese or milk?"

"For the last three months I have attended exercise classes twice weekly and now attend a maintenance class which I find very beneficial ... I was too frightened to do much on my own before ... I kept thinking I would do myself some damage."

"Getting some exercise has really helped my confidence."

Diet and exercise are discussed in section 4

1.4.4 are there any risks associated with my medication?

Many patients report feeling confused and anxious about the type of medication they have been prescribed. Women express concern about taking hormone replacement therapy (HRT), and the fear of breast cancer is very real.¹⁹

Undesirable side effects mean that some patients do not continue with their medication.^{12,13,20,21,22} Some experience gastric discomfort that they attribute to bisphosphonates.¹⁷

Pharmacological treatments are discussed in section 6

1.4.5 how can i manage this pain?

Patients report the pain following a vertebral fracture as excruciating. Everyday activities such as going to the hairdresser or on an outing to the theatre or cinema can be very painful, and many women are depressed by the difficulty they have in finding clothes that fit comfortably and also look good. It would be immensely helpful to know that health professionals understood these problems and could take them into account when assessing the impact on patients and their families.^23,24,25

"I slept in a chair for three months ... or crawled about the floor ... couldn't even wash my hair ... there seemed no end to the pain ... the painkillers didn't really work ... I became very depressed... I have lost all my confidence."

Pain management is discussed in section 6.11

1.4.6 other concerns

Calls made to the NOS helpline indicate that many patients diagnosed with osteoporosis do not receive enough information and support from the health professionals looking after them. Patients are often told that they have osteoporosis but are not given an adequate explanation of what this means or the implications of the disease, and this can be a bewildering and frightening experience for them.

As the patient with osteoporosis makes his or her journey from being identified as at risk, then through diagnosis and treatment, studies suggest that good communication, support and explanation is important at all stages. Good communication between patients, their families, carers, and health professionals alleviates some of the anxieties and concerns and improves compliance with long term treatments.^26,27 Practical information on such things as diet and exercise, and on adjunct methods of pain relief empowers patients to contribute to the management of their condition.²⁴

Going into hospital for any reason can be alarming for people with osteoporosis, especially if it is severe and they have already experienced fractures.^28,29

"I had terrible toothache... and abscess... I needed more treatment and he wanted me to go for a general anaesthetic in the hospital but I couldn't ... I might get broken when asleep!"

1.5 Statement of intent

This guideline is not intended to be construed or to serve as a standard of medical care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. These parameters of practice should be considered guidelines only. Adherence to them will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor in light of the clinical data presented by the patient and the diagnostic and treatment options available. However, it is advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken.

1.6 Review and updating

This guideline was issued in 2003 and will be considered for review in 2007, or sooner if new evidence becomes available. Any updates to the guideline in the interim period will be noted on the SIGN website: http://www.sign.ac.uk