1. Primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women
Implementing NICE guidance
ABOUT THIS PRESENTATION:
This presentation has been written to help you raise awareness of the following NICE technology appraisals:
Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women (TA160)
Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (TA161).
This guidance has been written for clinicians, local commissioners and service providers.
The technology appraisals are available in a number of formats. You can download these from the NICE website or order printed copies of the quick reference guides by calling NICE publications on or sending an to Quote reference numbers N1723 (TA160) and N1725 (TA161). You may want to hand out copies of the quick reference guides at your presentation so that your audience can refer to them.
You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters to help highlight key points to raise in your presentation and to provide supplementary information to the slides. Where necessary, the recommendation will be given in full. Please feel free to adapt, amend or remove these as you see necessary.
DISCLAIMER
This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself.
2008
NICE technology appraisal guidance 160 and 161

2. What this presentation covers
Definitions and scope
Background
Recommendations
Costs and savings
Discussion
Find out more
NOTES FOR PRESENTERS:
This presentation covers two NICE technology appraisals on drugs for the primary (TA160) and secondary (TA161) prevention of osteoporotic fragility fractures in postmenopausal women.
In this presentation we will start by providing definitions and an explanation of the scope for each technology appraisal and why it is important.
TA160 contains recommendations about the use of alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women.
TA161 contains recommendations about the use of alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.
Costs and savings that are likely to be incurred in implementing the guidance are summarised, followed by a suggested list of questions to help prompt discussion.
Information on how to find out more about the support provided by NICE is given at the end of this presentation.

3. Note: updated guidance
NICE reviews each piece of guidance it issues.
TA161 replaces NICE technology appraisal guidance 87 issued in January 2005.
The review and re-appraisal of alendronate, etidronate, risedronate, raloxifene and teriparatide for secondary prevention of osteoporotic fragility fractures has resulted in changes in the criteria for offering these drugs.
In addition, strontium ranelate has also been appraised.

4. Definitions BMD: bone mineral density
DXA: dual-energy X-ray absorptiometry
Fragility fracture: a low-trauma fracture
T-score: the number of standard deviations (SD) below the mean BMD of young adults at their peak bone mass
Osteoporosis: a T-score of −2.5 (SD) or below on DXA scanning
NOTES FOR PRESENTERS
Key points to raise:
Osteoporosis is a chronic 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.
The World Health Organization has established diagnostic criteria for osteoporosis based on the measurement of BMD, expressed as the T-score, which is the number of standard deviations (SD) below the mean BMD of young adults at their peak bone mass:
- normal BMD: T-score of −1 SD or above
- osteopenia: T-score of between −1 and −2.5 SD
- osteoporosis: T-score of −2.5 SD or below
- established (severe) osteoporosis: T-score of −2.5 SD or below with one or more associated fractures.
Additional information:
T-score measurements vary depending on the site and method of investigation. Measurement of BMD using central (hip and/or spine) DXA scanning can estimate fracture risk.
An osteoporotic fragility fracture is often referred to as a low-trauma fracture; that is, a fracture sustained as the result of a force equivalent to the force of a fall from a height equal to, or less than, that of an ordinary chair.
A diagnosis of osteoporosis may be assumed in women aged 75 years or older if a clinician considers a DXA scan to be clinically inappropriate or unfeasible.

5. Scope For the purposes of this guidance:
Primary prevention refers to opportunistic identification, during visits to a healthcare professional for any reason, of postmenopausal women who are at risk of osteoporotic fragility fractures and who could benefit from drug treatment. It does not imply a dedicated screening programme.
Secondary prevention relates only to treatments for the secondary prevention of fragility fractures in postmenopausal women who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture.
NOTES FOR PRESENTERS
Key points to raise:
TA160 does not cover the following:
The treatment of women who have already sustained a clinically apparent osteoporotic fragility fracture (covered by TA161).
The use of alendronate, etidronate, risedronate, raloxifene or strontium ranelate for the primary prevention of osteoporotic fragility fractures in women with normal bone mineral density or osteopenia.
The use of these drugs for the primary prevention of osteoporotic fragility fractures in women who are on long-term systemic corticosteroid treatment.
TA161 does not cover the following:
The use of alendronate, etidronate, risedronate, raloxifene, stontium ranelate or teriparatide for the secondary prevention of osteoporotic fragility fractures in women with normal bone mineral density or osteopenia.
The use of these drugs for the secondary prevention of osteoporotic fragility fractures in women who are on long-term systemic corticosteriod treatment.
The groups outlined in the notes above will be covered within future guidance produced by NICE.

6. Background In England and Wales, it is estimated that:
over 2 million women have osteoporosis
180,000 osteoporosis-related fractures occur annually
1 in 3 women over 50 years of age will sustain a vertebral fracture
2 million bed days annually are a result of fractures
annual social and hospital care costs £1.8 billion
NOTES FOR PRESENTERS
Key points to raise:
osteoporosis is most common in older white women.
after the menopause, the prevalence of osteoporosis increases markedly with age, from 2% at age 50 to more than 25% at 80 years.
postmenopausal women with an initial fracture are at substantially greater risk of subsequent fractures. For example, a woman with a vertebral fracture has the following increased relative risk: 4.4 for a further vertebral fracture; 2.3 for a hip fracture; and 1.4 for a wrist fracture.
annual bed days as a result of osteoporotic fractures on this slide refers to those in England.
Additional information:
There is a 1 in 3 lifetime risk of vertebral fracture for women aged over 50 years.
The Information Centre have produced an evaluation report on osteoporosis care: Hippisley-Cox, J Bayly, J et al (2007) Evaluation of standards of care for osteoporosis and falls in primary care Final Report to The Information Centre for health and social care, Information Centre.
The annual bed days due to fracture in England (for a population aged 60 years and over) are higher than those for heart disease and chronic obstructive pulmonary disease.
The annual social and hospital care cost for treating hip fractures featured on the slide is from: Lawrence T, White C, Wenn R, Moran C (2005) The current hospital costs of treating hip fractures. Injury 36:
Women are at greater risk of osteoporosis because the decrease in oestrogen production after the menopause accelerates bone loss to a variable degree.

7. Clinical need
Fragility fractures are the clinically apparent outcome of osteoporosis.
In the absence of fracture, osteoporosis is asymptomatic.
Hip fractures are associated with increased mortality.
50–70% of vertebral fractures do not come to clinical attention.
NOTES FOR PRESENTERS
Key points to raise:
Fractures are most common in the vertebrae, hip and wrist.
Osteoporosis is often undiagnosed until a person has a fracture.
Osteoporotic fragility fractures are associated with substantial disability, pain and reduced quality of life.
The relative mortality risk from hip fractures ranges from 2 to greater than 10 in the 12 months following a hip fracture.
Additional information:
Hip fractures impair a person’s ability to live independently: a high proportion of women are permanently unable to walk unaided or to perform other activities of daily living.
In patients who sustain a vertebral fracture, 40% will experience constant pain and debilitation. Kanis J, Johnell O, Oden A et al. The risk and burden of vertebral fractures in Sweden (2004) Osteoporosis International 15:

8. Risk factors and risk assessment
Independent clinical risk factors for fracture:
parental history of hip fracture
alcohol intake of 4 or more units per day
rheumatoid arthritis.
Indicators of low bone mineral density:
low body mass index below 22 kg/m2
ankylosing spondylitis
Crohn’s disease
conditions resulting in prolonged immobility
untreated premature menopause.
NOTES FOR PRESENTERS
Key points to raise:
For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.
For the purposes of this guidance, indicators of low bone mineral density are low body mass index (defined as less than 22 kg/m2), medical conditions such as ankylosing spondylitis, Crohn’s disease, conditions that result in prolonged immobility, and untreated premature menopause. Rheumatoid arthritis is also a medical condition indicative of low BMD.
TA160. Section 2.11:
In addition to increasing age and low bone mineral density, other clinical factors have been associated with increased fracture risk. Some of these are at least partly independent of bone mineral density, and include parental history of hip fracture, alcohol intake of 4 or more units per day, prior fracture, long-term systemic use of corticosteroids (the latter two of which are not covered in this guidance), and rheumatoid arthritis.
The same applies for TA161, but prior fracture is covered in that guidance.

9. Technologies
Alendronate, etidronate, risedronate (bisphosphonates) inhibitors of bone resporption and increase BMD by altering osteoclast activation and function.
Raloxifene (selective oestrogen receptor modulator) SERMs have selective activity in various organ systems, acting as either a weak oestrogen-receptor agonist or antagonist. Strontium ranelate an element with properties similar to calcium with a dual effect on bone metabolism, increasing formation and decreasing resorption.
Teriparatide (parathyroid hormone) a recombinant fragment of human parathyroid hormone which stimulates new formation of bone and increases resistance to fracture.
NOTES FOR PRESENTERS Additional information:
Bisphosphonates have relatively complex instructions for administration. Alendronate and risedronate must be taken with 200 ml and 120 ml of water, respectively. Before and immediately after administration, patients should not eat or drink and must remain upright for stipulated time periods. Etidronate should be taken with water at the midpoint of a 4-hour fast.
Alendronate is an oral preparation. An indicative annual cost per patient for: - non-proprietary alendronate is £53.56 for once-weekly (70-mg) tablets and £ for daily (10-mg) tablets; - proprietary alendronate is £ for once-weekly (70-mg) tablets and £ for daily (10-mg) tablets.
Etidronate is an oral bisphosphonate administered in 90-day cycles (more information on administration is provided in the notes of slide 15). An indicative annual cost per patient for etidronate is £85.65.
Risedronate is an oral bisphosphonate. An indicative annual cost per patient for risedronate is £ for daily 5 mg/day treatment, or £ for once-weekly 35 mg/week treatment.
Raloxifene
Treatment aims to maximise the beneficial effects of oestrogen on bone and to minimise the adverse effects on the breast and endometrium.
An oral once-daily treatment that can be taken with or without food. More information on contraindications for raloxifene are provided in the notes of slide 16.
An indicative annual cost per patient for 60 mg/day treatment is between £ and £
Strontium ranelate A divalent strontium salt of ranelic acid and is administered via a 2-g sachet taken daily as a suspension in water. More information is provided in the notes of slides 13. An indicative annual cost per patient for treatment with a 2-g daily sachet is £
Parathyroid hormone: teriparatide A once daily subcutaneous injection. More information on teriparatide can be found in the notes of slide 17. An indicative annual cost per patient for daily 20 micrograms pre-filled injection pen is £
Costs may vary in different settings because of negotiated procurement discounts.
Further information Bisphosphonates NHS National Prescribing Centre (2001) MeReC Bulletin 12: 5-8. Available from:
Raloxifene NHS National Prescribing Centre (1999) New medicines on the market: raloxifene. Monograph number: 4/99/03. Available from:

10. Adherence to treatment
Contraindications
Compliance with special instructions for administration
Intolerance
Bisphosphonates (alendronate, etidronate, risedronate) – persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, where instructions for administration have been followed correctly
Strontium ranelate – persistent nausea or diarrhoea, which warrants discontinuation of treatment
NOTES FOR PRESENTERS
Key points to raise:
Patient contraindications should be taken into account when deciding on a treatment, for example in those with oesophageal abnormalities and other factors that delay oesophageal transit or emptying. For full details of side effects and contraindications, see the summaries of product characteristics.
Prescription-event monitoring studies of alendronate from GPs in England point to a high incidence of symptoms of dyspepsia, particularly in the first month of treatment. Consultations for dyspepsia ranged from 32.2 per 1000 patient-months in the first month of treatment to 10.9 per 1000 patient-months in months 2 to 6.
Gastrointestinal adverse events including nausea, dyspepsia, mild oesophagitis/gastritis and abdominal pain were reported in at least one third of the participants in studies of alendronate reviewed for TA160 and TA161; which is consistent with post-marketing studies that indicate approximately one third of alendronate users experience gastrointestinal adverse events. It is possible that the drug summary of product characteristics instructions were not followed in all of the studies reviewed for this guidance, particularly the earlier ones.
To avoid oesophagitis and thereby aid continued adherence with treatment, product summary administration instructions are recommended to be followed. For example, the summary of product characteristics for alendronate state it should be taken on rising for the day, with a full glass of water.

11. Primary prevention: first treatment option
Initial treatment offered: alendronate
Postmenopausal women aged
Independent clinical risk factor for fracture
Indicator of low BMD
Osteoporosis confirmed
younger than 65 years
1 or more and
at least one additional indicator
Required
65–69 years
1 or more
n/a
70 years and older
1 or more or
Yes
Required In women ≥ 75 years: not required if two or more clinical risk factors or indicators of low BMD
NOTES FOR PRESENTERS
Key points to raise:
When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.
For those aged 75 years or older who have two or more independent clinical risk factors for fracture or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
Gastrointestinal side effects are common with oral bisphosphonates.
Alendronate is contraindicated in people with oesophageal abnormalities and other factors that delay oesophageal transit or emptying.
Recommendation 1.1 (TA 160) in full:
Alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in the following groups:
• Women aged 70 years or older who have an independent clinical risk factor for fracture (see section 1.5) or an indicator of low BMD (see section 1.6) and who are confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below). In women aged 75 years or older who have two or more independent clinical risk factors for fracture or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
• Women aged 65–69 years who have an independent clinical risk factor for fracture (see section 1.5) and who are confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below).
• Postmenopausal women younger than 65 years who have an independent clinical risk factor for fracture (see section 1.5) and at least one additional indicator of low BMD (see section 1.6) and who are confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below).

12. Primary prevention: alternative treatment option (1)
Alternative treatment – risedronate or etidronate when women:
are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and
have a combination of T-score, age and number of clinical risk factors as outlined in the table.
Number of independent clinical risk factors for fracture
Age (years) 1 2
65–69 a
−3.5
−3.0
70–74
−2.5
75 or older
a Treatment with risedronate or etidronate is not recommended.
NOTES FOR PRESENTERS
Key points to raise:
If a woman aged 75 years or older who has two or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.
Further information on conditions regarding when women are unable to take a treatment is provided on slide 10.
The table on this slide, and those on subsequent slides, are also available in the associated quick reference guide.

13. Primary prevention: alternative treatment option (2)
Alternative treatment – strontium ranelate when women:
are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and
have a combination of T-score, age and number of clinical risk factors as outlined in the table.
Number of independent clinical risk factors for fracture
Age (years) 1 2
65–69 a
−4.5
−4.0
70–74
−3.5
75 or older
−3.0
a Treatment with strontium ranelate is not recommended.
NOTES FOR PRESENTERS
Key points to raise:
The absorption of strontium ranelate is reduced by food, milk and products derived from milk and should be administered between meals, ideally at bedtime and preferably at least 2 hours after eating.
This drug is not recommended in patients with severe renal impairment and it should be used with caution in patients at increased risk of venous thromboembolism.
Strontium ranelate should be discontinued during treatment with oral tetracycline or quinolone antibiotics.
It should be noted that raloxifene is not recommended as an alternative treatment option for the primary prevention of osteoporosis.

14. Secondary prevention: first treatment option
Initial treatment offered: alendronate
Postmenopausal women with confirmed osteoporosis
A DXA scan may not be required in women aged 75 or over
NOTES FOR PRESENTERS
Key points to raise:
Recommendation 1.1 (TA161) in full: Alendronate is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below). In women aged 75 years or older, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.

15. Secondary prevention: alternative treatment option (1)
Alternative treatment – risedronate or etidronate when women:
are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and
have a combination of T-score, age and number of clinical risk factors as outlined in the table.
Number of independent clinical risk factors for fracture
Age (years) 1 2
50–54 a
−3.0
−2.5
55–59
60–64
65–69
70 or older
a Treatment with risedronate or etidronate is not recommended.
NOTES FOR PRESENTERS
Key points to raise:
Risedronate should be used cautiously with people with oesophageal abnormalities.
Etidronate is an oral bisphosphonate which is administered in 90 day cycles, with each cycle consisting of etidronate (400 mg/day) for 14 days followed by calcium carbonate (1.25 g/day) for the remaining 76 days.
In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.

16. Secondary prevention: alternative treatment option (2)
Alternative treatment – strontium ranelate or raloxifene when women:
are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and
have a combination of T-score, age and number of clinical risk factors as outlined in the table.
Number of independent clinical risk factors for fracture
Age (years) 1 2
50–54 a
−3.5
55–59
−4.0
60–64
65–69
−3.0
70–74
−2.5
75 or older
a Treatment with raloxifene or strontium ranelate is not recommended.
NOTES FOR PRESENTERS
Key points to raise:
In deciding between stontium ranelate and raloxifene, clinicians and patients need to balance the overall proven effectiveness profile of these drugs against their tolerability and other effects in individual patients.
If a woman aged 75 years or older who has one or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
Raloxifene:
is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women
is contraindicated in people with a history of venous thromboembolism; it is associated with an increased risk of venous thromboembolic events, particularly during the first 4 months of treatment
is contraindicated in people with hepatic impairment, cholestatis, severe renal impairment, undiagnosed uterine bleeding or endometrial cancer
should not be co-administered with systemic oestrogens and, in patients with breast cancer, should not be used for osteoporosis treatment or prevention until breast cancer treatment, including adjuvant treatment, has been completed.

17. Secondary prevention: alternative treatment option (3)
Alternative treatment – teriparatide when women:
are unable to take, have a contraindication to or are intolerant of alendronate and either risedronate or etidronate, or
have a contraindication to, or are intolerant of strontium ranelate or
have had an unsatisfactory response to treatment with alendronate, risedronate or etidronate and
have a combination of T-score, age and number of fractures as outlined in the table.
NOTES FOR PRESENTERS
Key points to raise:
Patients taking teriparatide must receive training in the injection technique required to administer the treatment subcutaneously into the thigh or abdomen.
Particular contraindications for teriparatide include pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases other than primary osteoporosis, unexplained elevations of alkaline phosphatase, and previous radiation treatment to the skeleton.
Unsatisfactory response to treatment is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.
Age (years)
T-score
Fractures
> 65 years
−4.0 SD or below –
−3.5 SD or below
More than two
55–64 years
−4 SD or below

18. Clinical management
Women currently receiving treatment that is not recommended in this guidance should have the option to continue treatment.
It is assumed women who receive treatment have an adequate calcium intake and are vitamin D replete – consider supplements if needed.
NOTES FOR PRESENTERS
Key points to raise:
Women who are currently receiving treatment with one of the drugs covered by TA160 and TA161, but for whom treatment would not have been recommended according to the guidance, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
Unless clinicians are confident that women who receive treatment meet the criteria on the slide regarding calcium and vitamin D intake, calcium and/or vitamin D supplementation should be considered.
In situations where alternative treatment options need to be considered, clinicians and patients need to balance the overall proven effectiveness profile of the drugs in question against their tolerability and other effects in individual patients.
Wider clinical management resources
A fracture event provides the opportunity for a clinical intervention including osteoporosis assessment and the initiation of treatment where appropriate.
Where available, a fracture liaison service (FLS) may help to streamline a patient’s care by identifying appropriate patients within secondary care and engaging them in a osteoporosis treatment pathway.
Approximately 30% of UK hospitals currently have a FLS.
A useful reference for clinical care standards may be found in: British Orthopaedic Association and British Geriatrics Society (BOA-BGS) (2007) Blue book: the care of patients with fragility fracture second edition. London: British Orthopaedic Association.
A useful resource is the national audit project: the national hip fracture database (NHFD; an initiative from the BOA-BGS and operated by the Information Centre for Health and Social Care’s National Clinical Audit Support Programme [NCASP]). The NHFD provides a benchmark of care across the country, and uses comparative data to create a drive for sustained improvements in clinical standards and cost effectiveness.

19. Costs and savings Primary and secondary prevention per 100,000 population
Primary prevention
Costs and savings
(£ per year)
Estimated cost of implementation
6,642
Estimated savings from implementation
6,816
Secondary prevention
Estimated costs of implementation
30,733
9,206
ADAPTING THIS SLIDE FOR LOCAL USE:
We are aware that local factors such as incidence and baseline can vary considerably when compared with the national average. NICE has provided a costing template for you to calculate the financial impact this technology appraisal will have locally. We encourage you to calculate the local impact of this guidance by amending the local variations in the template such as incidence, baseline and uptake. You can then remove the national figures from the table and replace them with your local figures to present to your colleagues.
NOTES FOR PRESENTERS:
The information on this slide has been extracted from the NICE costing report, which has been provided by NICE to support implementation of this guidance. It was developed after careful consideration of the available data and by working closely with the people within and outside the NHS. It is not NICE guidance. Assumptions used in this report are based on assessment of the national average and it is recognised that local practice or circumstances may differ from this. The costs published in this report are estimates only and are not to be taken as the Institute's view of desirable, or maximum or minimum figures.
NICE has also provided a costing template to help calculate the local costs associated with implementing this guidance. The costs per 100,000 population are summarised in the table.
Key points to raise:
The average length of time that a patient is prescribed a medication for osteoporosis is 5 years, it is therefore assumed that it will take 5 years to fully implement this technology appraisal.
In addition to savings generated by reducing the number of fractures, the avoidance of fractures will also lead to a reduction in the number of women who are prevented from living independently. This will result in savings to the NHS and social services, but it has not been possible to estimate these here.
Implications for commissioners: pharmacotherapies outlined within TA 160 and TA 161 are recommended for the treatment of osteoporosis in either primary care or secondary care. Where they are given in secondary care, they and the associated activity will form part of payment by results.
The costs of drugs are likely to fall within the programme budgeting category 15X (Musculoskeletal problems).
In addition, compliance with NICE guidance is one of the criteria indicating good risk reduction strategies, and in combination with meeting other criteria could lead to a discount on contributions to the NHS Litigation Authority schemes, including the clinical negligence scheme for trusts (CNST).
For further information please refer to the costing template and costing report for this guidance on the NICE website.

20. For discussion
How/or will current local prescribing arrangements need to change as a result of this guidance?
How can we increase adherence to therapy?
What arrangements currently exist regarding access to DXA scanning for this patient group?
How can we improve links between primary and secondary care to improve the care of women with osteoporosis?
NOTES FOR PRESENTERS
Key points to raise:
A prescription-event monitoring study of patients prescribed alendronate found that 30% appeared to discontinue treatment within 6 months. In another 12 studies reviewed for TA 160 and TA161 persistence with treatment at 1 year ranged from 16% to 90%.
A NICE guideline on Medicines adherence is due to be published in January 09. The guideline will provide support for clinicians in increasing a patient’s adherence to medication regimens, which will be appropriate both for osteoporosis treatment therapies as well as calcium and vitamin D supplementation.
These questions are suggestions that have been developed to help provide a prompt for a discussion at the end of your presentation – please edit and adapt these to suit your local situation.
Additional questions for discussion:
What is the role for practice-based commissioning in the prevention of fragility fractures?
What workforce development or training issues may need to be addressed in light of TA160 and TA161?
How is the prescribing of calcium and/or vitamin D supplementation within this patient group addressed locally?
How can learning from local falls strategies/Fracture Liaison Services be utilised?

21. Find out more
Visit and for:
Other guidance formats
Costing report and template
Audit support
NOTES FOR PRESENTERS
NICE technology appraisals are available in a number of formats.
The quick reference guide – which summarises the guidance.
The full appraisal – including all of the evidence and rationale.
‘Understanding NICE guidance’ – a version for patients and carers.
You can download these from the NICE website or order printed copies of the quick reference guide and ‘Understanding NICE guidance’ by calling NICE publications on or by sending an to Quote reference number N1723 (TA160) and N1725 (TA161) for the quick reference guide and N1724 (TA160) and N1726 (TA161) for the ‘Understanding NICE guidance’. You may want to hand out copies of the quick reference guide at your presentation so that your audience can refer to it.
NICE has developed tools to help organisations implement this guidance, which can be found on the NICE website.
Costing tools – a costing report gives the background to the national savings and costs associated with implementation, and a costing template allows you to estimate the local costs and savings involved.
Audit support – assists NHS trusts to determine how well they meet NICE recommendations.