Dr Pam Brown discusses how the consensus guideline will assist primary care teams with the diagnosis and management of osteoporosis in post-menopausal women


  • This working party guideline was developed during a one-day meeting
  • The development of this guidance was supported by an educational grant from Roche Products Ltd and GlaxoSmithKline
  • The content of the working party guideline and this article is independent of and not influenced by the commercial sponsorship
 

Osteoporosis is a progressive disease affecting all parts of the skeleton—the bones become thinner and less structurally sound, increasing the risk of fracture. The fractures caused by osteoporosis cost around £1.7 billion annually in the UK according to 2003 figures.1

Hip fracture results in significant mortality (around 20% at one year),2 morbidity, and loss of independence (around 20% of patients recovering from hip fractures end up unable to walk or live independently3 ). Osteoporotic fractures also increase the primary care workload significantly (a patient will have around 12 extra consultations in the year following a vertebral fracture4 ), as well as hospital bed use, impacting on waiting lists for elective orthopaedic surgery.

Why was a consensus guideline developed?

Despite the publication in 2005 of the NICE technology appraisal on the secondary prevention of osteoporotic fragility fractures in post-menopausal women,5 recent estimates suggest that only 10–14% of women who would benefit are being treated.6 This is particularly surprising when one considers osteoporosis as a chronic disease, exactly like cardiovascular disease (CVD) or diabetes, with fragility fractures representing the acute exacerbation. Primary care teams are good at dealing with other chronic diseases, and always manage the underlying cause; for example, treating underlying risk factors when patients suffer a myocardial infarction (the acute exacerbation), in a bid to reduce their chance of suffering future infarcts. Yet the majority of women who suffer a low trauma fracture (a fracture—excluding finger, toes, or skull—caused by a fall from standing height or less in someone over the age of 50 years) do not receive treatment even if they have osteoporosis, despite the fact that they have a greatly increased risk of future fractures.6

The quality and outcomes framework (QOF) of the new GMS contract7 involves increased workload demands for GPs in other areas, which may be detracting from rates of diagnosis and treatment for osteoporosis in primary care. Inclusion of osteoporosis in the QOF would help to improve these rates by giving GPs an incentive to identify and treat high-risk groups. Many doctors remain confused by how to integrate and implement information from the range of previous guidance documents, including those from NICE and the Royal College of Physicians.8–10 In addition, the delays by NICE in producing and updating definitive guidance on both primary and secondary prevention of osteoporotic fragility fractures in post-menopausal women, means that many GPs are delaying taking action on osteoporosis and fracture prevention in their practices until this guidance becomes available.

In late summer 2006, the working party involved in producing this guideline decided it was time to address the urgent need for a concise, user-friendly, consensus document,11 combining currently available formal guidance/guidelines with practical, evidence-based advice in areas of less clarity. The working party comprised a specialist in geriatric medicine, a consultant rheumatologist, two GPs, a nurse specialising in osteoporosis, and a pharmacist. The agreed format was a central algorithm (Figure 1), a concise guideline document that was published in Guidelines,12 and a more detailed guideline for those who wanted access to additional background information.11Available UK guidance and guideline documents on osteoporosis were reviewed and integrated where they were still felt to represent best practice.

The consensus guideline was published in October 2006, and initial word of mouth feedback to the working party group from GPs has been strongly positive. Further appraisal consultation documents for primary and secondary prevention of osteoporotic fractures in post-menopausal women were published by NICE in February 2007; final appraisal documents (FADs) may be available as early as June 2007. However, there is still no publication date for the NICE osteoporosis guideline.

Figure 1: Algorithm for the management of osteoporosis in primary care

Figure 1: Algorithm for the management of osteoporosis in primary care
* Falls assessment should be carried out on those at risk — consider secondary care where appropriate;
The bracketed numbers refer to the numbered sections (treatment options) in Box 4
GC=glucocorticoid; DXA=dual-energy X-ray absorptiometry
Adapted from the Swansea osteoporosis service algorithm, November 2005.

Assessment of osteoporosis and fracture risk

All currently available guidance recommends a case-finding strategy for assessment, where those who are at high risk of future fractures are identified, investigated to confirm osteoporosis or other disease, and then managed appropriately. This is more cost-effective than population screening and reflects current secondary prevention strategies for CVD. Patients in the high-risk groups shown in Box 1 can be identified opportunistically at normal GP consultations, by auditing patient records proactively, and by encouraging patients to identify their high-risk status themselves. Four tools can be used, where appropriate, to confirm the presence of osteoporosis, to identify who to treat, and to highlight those with other diseases that need different management. These are as follows:

  • dual-energy X-ray absorptiometry (DXA)
  • spinal X-ray
  • fracture risk assessment
  • other investigations such as blood testing and bone scans.

Diagnosis of osteoporosis and therapy decisions for primary or secondary fracture prevention will usually require DXA of hip and spine, apart from in women 75 years and older who can begin treatment without undergoing DXA. Categories of patient who may qualify for DXA, where it will influence management, are shown in Box 2.

Where there is no access to hip and spine DXA, peripheral DXA (but not ultrasound scanning) can be used to measure bone density at the forearm, heel, or finger. Results should be interpreted on the basis of device-specific bone mineral density (BMD) thresholds, as recommended by the National Osteoporosis Society.13 Patients with BMD below the lower device-specific threshold need treatment, those whose BMD is above the upper device-specific threshold can be reassured, and the approximately 40% of patients who are between the lower and upper thresholds should be referred for DXA of hip and spine to ascertain the need for treatment.11

Fracture risk assessment can also be carried out by combining BMD measurement, if available, with a variety of other risk factors, such as age, smoking habit, alcohol intake, falls risk, and previous fracture.11 This will be formalised into calculation of a 10-year absolute fracture risk in the WHO Fracture Risk Assessment Tool, which is expected to be available later in 2007.

Clinicians need to decide which investigations they believe are appropriate in individual patients with low trauma fractures or whose BMD is low for their age. Studies show low pick-up rates for abnormalities,14, 15 but it is important not to miss other contributing factors, such as myeloma or coeliac disease. Recommendations for investigations are shown in Box 3 .11

Box 1: Groups at high risk of osteoporosis

  • Previous low trauma fracture or vertebral compression fracture
  • Use of oral GCs, at any dose, for >3 months
  • Frail or house-bound elderly people
  • Those with other risk factors such as:
    • parental history of fracture
    • chronic diseases (coeliac disease, inflammatory bowel disease, rheumatoid arthritis, hyperparathyroidism)
    • early-onset menopause (<45 years)
    • low BMI (<19 kg/m2)
  • Those receiving aromatase inhibitor therapy (this group should be managed in secondary care)
 
GC=glucocorticoids; BMI=body mass index

Box 2: Groups who may qualify for DXA, where it will change management11

  • Previous low trauma fracture or vertebral compression fracture
  • Users of oral GCs for ?3 months if under the age of 65 years and no previous fracture
  • Those with other risk factors as cited in Box 1
  • Those with radiographic evidence of osteopenia and/or vertebral deformity
  • Those with loss of height, thoracic kyphosis (and radiographic evidence of vertebral deformity)
  • Those with primary hypogonadism
 
DXA= dual-energy X-ray absorptiometry; GC=glucocorticoids

Box 3: Investigations for low trauma fractures or low BMD for age

Low-trauma fracture10

 

  • Full blood count, erythrocyte sedimentation rate
  • Bone and liver function tests (calcium, phosphorus, alkaline phosphatase, albumin, aspartate aminotransferase/gamma-glutamyl transferase)
  • Serum creatinine
  • Serum thyroid-stimulating hormone
  • If indicated:
    • lateral thoracic and lumbar spine X-rays
    • serum paraproteins and urine Bence-Jones protein for patients with
    • vertebral fractures
    • isotope bone scan
    • serum follicle stimulating hormone if hormonal status unclear

Low BMD for age (Z score <–1.5)

 

  • As for low trauma fracture (above) with the exception of paraproteins and isotope scan

Extremely low BMD (T score <–3.0)

 

  • As for low trauma fracture (above) with the exception of paraproteins and isotope scan
 

Management

All patients at risk of fractures should receive counselling on smoking cessation, limiting alcohol consumption to 2 units per day, eating a balanced diet containing adequate calcium, taking regular weight-bearing exercise, and ensuring regular exposure to sunlight (15–20 minutes on the hands, face, and forearms, twice weekly from April to October should supply year-round needs).11Patients should be asked about falls, and fallers asked to undertake a 'Get up-and-go' test. Those who experience repeated falls or those with an abnormal result from the test should be referred to a falls assessment clinic.

Treatment of osteoporosis

The consensus guideline lists only those products that are actually licensed for treatment of osteoporosis in post-menopausal women (see Box 4), but, in my experience, most clinicians use the bisphosphonates (alendronate, risedronate, and ibandronate) interchangeably, depending on the preference and tolerability of individual patients. Ibandronate is not licensed for use in glucocorticoid-induced osteoporosis.

Primary prevention of fracture

Licensed treatments are listed in Box 4 . Primary prevention of fractures is based on the Royal College of Physicians and Bone and Tooth Society guidance from 1999/2000,9,10 which recommends that treatment should be considered if osteoporosis is confirmed on DXA (T-score <–2.5).10 This differs from the current proposal in the most recent primary prevention appraisal consultation document,16 which only recommends treatment in those aged >70 years if they have not had a fracture. Treatment thresholds in the RCP guideline are inconsistent with those for women with previous fracture, who are covered by the newer NICE guidance.5 However, this is the only evidence-based guidance available on which to base this consensus at present.

Secondary prevention of fracture

Secondary prevention is based on DXA scan results, except in patients ?75 years who can commence treatment immediately. In those aged 65–74 years or <65 years, treatment should be started straight away if a delay in DXA scan is likely. Licensed treatments are outlined in Box 4 .

Glucocorticoid-induced osteoporosis

Management of men and women committed to treatment with oral glucocorticoids (GC) for ?3 months is different from that of other groups. Those aged ?65 years, or who have had a previous low trauma fracture, need treatment and do not need DXA. For others, the treatment threshold is a T score of <–1.5, as bones fracture at a lower threshold in those receiving GC treatment.8

Calcium and vitamin D

Use of calcium and vitamin D as a monotherapy has only been shown to reduce the risk of fractures in elderly women who are already likely to be vitamin D deficient and living in nursing homes.17They are also recommended as an adjunct to other treatments.5

Box 3: Investigations for low trauma fractures or low BMD for age

(1) Primary prevention of fracture

  • Oral bisphosphonates: alendronate, etidronate, ibandronate, or risedronate
  • Raloxifene
  • HRT


(2) Secondary prevention of fracture

  • First-line therapy
    • oral bisphosphonates: alendronate, etidronate, ibandronate, or risedronate
  • For patients where oral bisphosphonates are not tolerated or are contraindicated:
    • raloxifene
    • strontium ranelate
    • intravenous ibandronate (usually initiated in secondary care)
    • parathyroid hormone (usually initiated in secondary care)
    • HRT †
  • Adjunctive calcium and vitamin D

(3) Glucocorticoid-induced osteoporosis

  • Oral bisphosphonates: alendronate, etidronate, or risedronate
  • Adjunctive calcium and vitamin D16

(4) Calcium and vitamin D monotherapy

  • Fracture reduction only shown in elderly women in care homes
  • There is no evidence that this treatment alone is effective in individuals not in care homes

(5) Calcium and vitamin D adjunctive therapy

  • Fracture reduction only shown in elderly women in care homes
  • The adjunctive use of calcium and vitamin D with other osteoporosis treatments is recommended by NICE5
*Since the publication of the consensus guideline,11 the EMEA has introduced the indication ‘the treatment of osteoporosis in post-menopausal women at increased risk of fracture’ because the theoretical basis for differentiating an indication of osteoporosis ‘prevention’ from ‘treatment’ is no longer substantiated. The author has taken this new indication into account, which has resulted in some differences between this article and the consensus guideline11 

not currently recommended for first-line use in women aged >50 years

HRT=hormone replacement therapy; NICE=National Institute for Health and Care Excellence; EMEA= European Agency for the Evaluation of Medicinal Products

Monitoring

Primary care teams have an important role in monitoring treatment, which encourages adherence (taking therapy appropriately) and persistence with therapy (continuing therapy on a long-term basis). An initial 3-month review after initiating therapy is recommended, followed by twice-yearly review. This will ensure patients are tolerating the prescribed therapy, and that they are adhering to the prescription instructions and thus ensuring optimal absorption of the drug. Practice-wide audits and medication reviews will identify those who default from therapy. These patients can then be recalled and therapy switches undertaken if needed.

Referral

Most patients at high risk of future fracture can be managed successfully and safely in primary care. Referral should take place in the following cases:

  • diagnostic difficulty
  • intolerance or contraindication to oral therapy
  • acute painful vertebral fracture for consideration for vertebroplasty or kyphoplasty if unresponsive to treatment
  • secondary osteoporosis requiring further investigation
  • potential use of parathyroid hormone
  • more extensive investigation of falls.

Conclusion

This consensus guideline, and particularly the algorithm, will make it easier for primary care teams actively to identify and manage patients at high risk of osteoporosis and fragility fractures. It is expected that this will raise the standard of care and help reduce the number of fractures. In the meantime, we await publication of guidance on primary and secondary prevention in the NICE FADS, which are expected shortly, and the full clinical guideline, which should be available later this year. These documents should provide evidence-based and cost-effective guidance in those areas where there is variation or controversy in current practice.

 

  • Only about 15% of women who would benefit from osteoporosis prevention are receiving it
  • This consensus guidance will drive need for DXA scans and pharmacotherapy
  • DXA scans have no specific tariff price and are suitable for community provision under PBC (cheaper than from hospitals)
  • Tariff price: rheumatology outpatient (for DXA) = £2241
  • Fractured neck of femurs are expensive — tariff price = £47511
  • The PBC guidance includes guidance on unbundling the tariff for fractured neck of femur to reward shorter hospital stays with lower prices1
  1. Scottish Intercollegiate Guidelines Network. SIGN 71: Management of osteoporosis: A national clinical guideline. Edinburgh: SIGN, 2003.
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  4. Dolan P, Torgerson D. The cost of treating osteoporotic fractures in the United Kingdom female population. Osteoporosis Int 1998; 8 (6): 611–617.
  5. National Institute for Health and Care Excellence. Technology Appraisal 87: Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. London: NICE, 2005.
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  7. British Medical Association. Revisions to the GMS Contract, 2006/07. Delivering Investment in General Practice. London: BMA, 2006.
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  13. National Osteoporosis Society. Position statement on the use of peripheral X-ray absorptiometry in the management of osteoporosis. Bath: NOS, November 2004.
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