Expert opinion: new guidelines for the treatment of osteoporosis

Fracture risk calculation is an essential tool in the management of osteoporosis. By Dr Alun Cooper

ABSTRACT

The new user-friendly guidance on prevention and treatment of osteoporosis is web-based and features FRAX, a fracture risk assessment tool designed to calculate patients' 10-year probability of experiencing a major osteoporotic fracture.

Key words
Osteoporosis, fracture, risk assessment

Osteoporotic fragility fractures are a major burden on our health service, costing approximately £2 billion per year.1 One in two women and one in five men will have such a fracture in their lifetime after the age of 50 years. These fractures account for more than 2 million hospital bed days, more than any other disease, including ischaemic heart disease, diabetes and COPD.

NICE guidance on osteoporosis
The NHS has been waiting since 2002 for NICE to publish its guideline on the management of osteoporotic fragility fracture. This should replace the Royal College of Physicians (RCP) guidance on the prevention and treatment of postmenopausal osteoporosis and on the management of men and women taking glucocorticosteroids, published in 2000 and 2002 respectively.

In 2005, NICE produced a technology appraisal that was last year superseded by two technology appraisals2,3 on the use of medications for primary and secondary prevention of osteoporotic fractures in postmenopausal women. These offer no advice for men or those taking glucocorticoids.

A further shortcoming is that there is no advice for people with osteopenia, who are still at high risk of fracture as a result of other clinical risk factors. The National Osteoporosis Society criticised the guidance for being too complicated, inflexible and unethical. Furthermore, newer treatments, such as zoledronate and ibandronate, have not been included.

Towards a new guideline
FRAX, a fracture risk assessment tool has recently been developed by WHO. This calculates a person's 10-year probability of experiencing a major osteoporotic fracture (wrist, humerus, vertebra, hip) or hip fracture alone, based on clinical risk factors.

In the same way that various risk factors are used to calculate 10-year risk of cardiovascular disease, other clinical risk factors exist for fracture that are at least in part independent of bone mineral density (BMD; see box 1). FRAX can be used with or without BMD and is country-specific.

BOX 1: RISK FACTORS
Clinical risk factors increasing fracture risk
  • Increasing age
  • Female sex
  • Low BMI (≤19kg/m2)
  • Previous fragility fracture
  • Parental history of hip fracture
  • Current use of glucocorticoids (any dose for ≥3 months)
  • Current smoking
  • Alcohol intake ≥3 units per day
  • Rheumatoid arthritis

It was against this background that the National Osteoporosis Guideline Group (NOGG) updated the original guidance from the RCP. This has been endorsed by:

 

Fig 1: Management algorithm for the assessment of patients at risk of fracture.
Source: NOGG

The NOGG guideline is web-based and there is a direct link from the FRAX website. Those at risk should be identified opportunistically, either because they have already had a fracture or because they have a clinical risk factor for fracture or disease associated with low BMD (see box 2). First, FRAX is used to calculate fracture risk. Then, by clicking on the NOGG button, the value is superimposed on a graph of intervention thresholds. This value can be calculated with or without knowledge of the BMD.

BOX 2: LOW BONE MINERAL DENSITY
Conditions associated with a low BMD
  • Untreated hypogonadism
  • Organ transplantation
  • Type-1 diabetes
  • Hyperthyroidism
  • GI disease
  • Chronic liver disease
  • COPD
  • Prolonged immobility

The intervention thresholds are based on RCP and European guidelines. Fracture risk thresholds are equivalent to the risk for a postmenopausal woman who has already sustained a fracture. This is age-dependent, so treatment is determined by age-specific absolute risk.

Patients with probabilities below the lower risk threshold can be reassured and perhaps reassessed in five years. If the FRAX estimation has been made without BMD and the value lies in the intermediate zone, a DXA scan should be considered and the risk recalculated using the BMD.

Men and women with a risk above the intervention threshold should be considered for treatment. In postmenopausal women who have sustained a fragility fracture, it is appropriate to consider treatment without measuring BMD, but in younger women, DXA should be considered, especially if the degree of trauma is not certain.

The guideline also has a management algorithm for those without computer access. An executive summary and pocket summary, a patient information leaflet and some frequently asked questions are all available on the website.

Recommended management options
The management of patients includes a falls risk assessment, maintenance of mobility and correction of nutritional deficiencies. Daily intakes of at least 1g calcium, 800IU vitamin D and 1g/kg body weight of protein are recommended.

The main pharmacological interventions are bisphosphonates, strontium ranelate, raloxifene and parathyroid hormones (see box 3). The low cost of generic alendronate and its broad spectrum of antifracture data make it the first-line treatment for most cases. All of the treatment recommendations are cost-effective if generic alendronate is used for 80 per cent of cases.4

BOX 3: PHARMACOLOGICAL INTERVENTIONS
Main interventions for osteoporosis
DrugVertebral fracture
Non-vertebral fracture
Hip fracture
Alendronate
Ibandronate√*NAE
Risedronate
Zoledronate
RaloxifeneNAENAE
Strontium ranelate
TeriparatideNAE
Recombinant human parathyroid hormone (1-84)
NAENAE
√ Shown to reduce risk. *Post-hoc analysis subset patients. NAE: not
adequately evaluated

For patients in whom it is contraindicated or where the patient is intolerant, other bisphosphonates, strontium ranelate or raloxifene may be appropriate.

Parathyroid hormones are restricted to those at very high risk because of the cost of medication. There is no distinction between prevention and treatment of fragility fractures.

The NOGG guideline also includes recommendations for training, health authorities and other healthcare commissioners. Finally, as new treatment options are being developed, it is recommended that the guidelines should be reviewed within the next five years and osteoporotic fracture prevention should be included in the quality and outcomes framework. The user-friendly approach to absolute fracture risk assessment should help to target resources more accurately and facilitate treatment for patients with this 'silent' disease.

Dr Alun Cooper is a GPSI in osteoporosis in Crawley, West Sussex, and a member of the NOGG writing group

Competing interests: Dr Cooper has worked in an advisory capacity and/or received research grants from all major pharmaceutical companies in the field of osteoporosis, including MSD, Pfizer, P&G, Roche, GSK Servier, Novartis, Shire, Prostrakan and Lilly

References
1. British Orthopaedic Association, British Geriatric Society. The care of patients with fragility fracture. BOA, London, 2007.
2. NICE. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women. TA160. NICE, London, October 2008.
3. NICE. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. TA161. NICE, London, October 2008.
4. Kanis JA, Adams J, Borgstrom F et al. The cost-effectiveness of alendronate in the management of osteoporosis. Bone 2008; 42: 4-15.

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