Microsoft word - central lancs bone health _pmd, author & librarian changes_ 08-06-11.doc

CENTRAL LANCASHIRE BONE
HEALTH PATHWAY
REFERENCE NUMBER
APPROVING COMMITTEE(S) AND DATE
Clinical Governance and Risk Management Forum

AUTHOR(S) / FURTHER INFORMATION
Central Lancashire Osteoporosis work stream LEAD DIRECTOR
THIS DOCUMENT REPLACES
REVIEW DUE DATE
RATIFICATION DATE/DRAFT No
VALIDATION SIGNATURE
Introduction

Osteoporosis is described as a progressive systemic skeletal disease characterised
by low bone mass and micro architectural deterioration of bone tissue, with a
consequent increase in bone fragility and susceptibility to fracture (World Health
Organisation)
The clinical significance of osteoporosis is fracture, with more than one third of adult
women and one in five men sustaining one or more fractures in their lifetime.
The most commonly associated age related fractures are wrist, spine, hip, humerus
and pelvis. Injuries such as fractured vertebrae and wrist fractures disable the older
person in terms of pain, loss of independence and an inability to cope. Hip fractures
place heavy demands on the health service and significant health and social costs on
the older person, family and carers.
Hip fractures alone account for more than 20% of orthopaedic bed occupancy in the
UK, and the majority of direct health service cost of osteoporosis. Approximately 50%
of patients sustaining a hip facture can no longer live independently, and within 12
months of hip fracture 20% of patients will have died.
Over the next 50 years the ageing UK population will see a rise to a doubling of the
osteoporotic hip fractures, if changes are not made in present practise.
Scope
The Central Lancashire Bone Health Pathway determines locally agreed best
practise for patients who are at risk of osteoporosis and fracture for men and women.
The pathway includes both primary and secondary prevention and management.
Compatibility with NICE/other guidelines
• Bone and Tooth Society, National Osteoporosis Society, Royal College of Physicians (2002) Glucocorticoid-induced osteoporosis: guidelines for prevention and treatment • NICE (2008) Alendronate, etidronate, risedronate, raloxifene, strontium renelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women • NICE (2008) Alendronate, etidronate, risedronate, raloxifene and strontium renelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women • National Osteoporosis Guideline Group (2008) Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK • NICE (2010) Denosumab for prevention of osteoporotic fractures in post Primary and Secondary Prevention of Osteoporotic Fracture in Men and Post-
menopausal Women
Supplementary notes to pathway and guidelines
Abbreviations used in flow chart
CRF Clinical Risk Factor (listed below)
FRAX Fracture Risk Assessment Tool (link below)
DXA Dual X-Ray Absorptiometry (technique of measuring bone density – see
below)
NOGG National Osteoporosis Guideline Group (link below)
HRT Hormone replacement therapy
How to use the guideline
Simply identify into which of the top 3 blue balloons your patient belongs. If you
cannot do this then do not use the guideline and seek expert advice.
After locating your patient within a blue balloon, follow the arrows and directions of
the flow chart.
If your patient passes through the central portion of the pathway, you are first
directed to assess the absolute fracture risk (using FRAX, link given below) and then
you are directed to NOGG, (link given below) for advice on treatment thresholds. In
NOGG by using your patient’s age and the absolute fracture risk from FRAX, you will
be able to put the patient into a higher or lower risk group and hence determine the
need for treatment.
Author Comment:
Please replace the above para highlighted in red with
If the Guideline recommends you to use either FRAX or NOGG, they can be
accessed by using the links HTTP://shef.ac.uk/FRAX/ and
Field Code Changed
HTTP://shef.ac.uk/NOGG.
FRAX gives you the absolute fracture risk for your patient, ( for any fragility fracture
and specifically hip fracture) and NOGG indicates whether this level of risk lies above
the treatment threshold.
Clinical risk factors (Author comment OK) for the assessment of fracture
Deleted: used
probability (NOGG)
Low body mass index (≤19kg/m2)
Previous fragility fracture, particularly of the hip, wrist and spine including
morphometric vertebral fracture
Parental history of hip fracture
Current glucocorticoid treatment (any dose, by mouth for 3 months or more)
Current smoking or significant smoking history Author comment OK
Alcohol intake of 3 or more units daily
Secondary causes of osteoporosis including:

What about Chronic kidney disease Author comment. Chronic Kidney disease not Formatted: Bullets and Numbering
specifically mentioned by NOGG. Don’t ask me why! Formatted: Bullets and Numbering
Falls – not a risk factor for assessment purposes, but needs to be considered

DXA scanning
Where there has been a fracture, a DXA scan should be requested by the
Deleted: it is preferable for
orthopaedic team in the fracture clinic. However all further bone health Deleted: to be
advice/management should be undertaken by the General Practitioner (GP). Deleted: ioner
The scan result will be sent to the GP, with a copy filed in hospital notes. Request forms for DXA scans should be available in all relevant clinical areas. Deleted: generally
Nearby DXA scanning facilities exist at Blackpool (Clifton Hospital, Lytham) and
Lancaster Royal Infirmary. Author comment OK
Discharge summary/ communication to primary care
For communication from secondary to primary care Author comment OKinformation
Deleted: suggested
for inclusion is: • Site of any fracture • Details of prescribing commenced/considered • Whether a DXA scan referral has been made/ not required
• Details of Falls assessment or referral to Falls services

Specialist Referral
1) Not all fragility fractures are caused by primary osteoporosis. If the clinician
suspects that other disease weakens the bone e.g. cancer, then a specialist referral should be considered. 2) Patients who have a Z score of –1 or less are markedly different from their peers (what is the significance) Author comment- please continue sentence with Deleted: ificane
“and are in the lowest quartile as regards bone strength”. They may need referral for further investigations(which patients ). Author comment Change ‘They may need etc’ to “ They should be referred if this situation does not already have a clear explanation or management. After one year ofcompliance with prescribed treatment and adequate duration( define) have has been checked, any fractures occurring on treatment Deleted: ,
here, should be referred to a specialist clinic. 4) Consideration should be given to specialist referral for men 5) When referring to the osteoporosis clinic, PLEASE REMEMBER TO GIVE FULL NUMERICAL DETAILS OF ALL DXA SCANS or copy of scan Author comment Deleted: e
Deleted: A
Deleted: .
Investigations to exclude other bone disease:
Please note, selection of the appropriate test(s) depends on the clinical setting.
FBC, ESR, U&E, LFT, Bone chemistry
TSH, sex hormone levels, gonadotrophins
myeloma screen, PSA,
Vitamin D (25OHD3), PTH. OK
Deleted: v
Also breast examination, CXR and bone isotope scan may be required If in doubt, seek specialist advice. Patients on Glucocorticoids
See accompanying LTHTR guidelines on prophylaxis of glucocorticoid induced
osteoporosis.

To quantify absolute fracture risk and check treatment threshold
The Fracture Risk Assessment Tool FRAX can be accessed at:
HTTP://shef.ac.uk/FRAX/ This provides a 10-year absolute fracture risk for all
osteoporotic fractures and also specifically for hip fracture. On its own this
information is limited because of the need to have a treatment threshold. It is
therefore recommended that the absolute risk values from FRAX and the patient’s
age be entered into NOGG. This will inform the clinical decision by plotting the
patient in relation to the treatment threshold. Usually while using FRAX your patient
will be automatically put into NOGG by clicking on the NOGG link. In case of difficulty
the e-address for NOGG is: HTTP://shef.ac.uk/NOGG
Lifestyle Advice
Formatted: Font: Bold
You are recommended to ensure adequate Calcium and Vitamin D status, see below. Also to advise your patients not to smoke, to consume less than 4 units of alcohol daily and to take regular weight bearing exercise. Deleted:

Calcium and Vitamin D status

Assessment of calcium and vitamin D status, lifestyle advice and consideration of
falls assessment should be made for all patients with or at risk of osteoporosis.

Patients in all treatment groups should have an adequate calcium intake and vitamin
D status.
Daily calcium intake should be at least 700mgs daily (as recommended by NOS) and
can be checked using the calcium calculator found on www.prestonhipday.org.uk
Vitamin D status generally depends on regular exposure to natural sunlight. In case
of any doubt measure serum Vitamin D3.
For elderly individuals in institutional care or housebound, supplementation is
recommended. 1000mg calcium & 800IU vitamin D (NOGG) is the evidence- based
dose.
Treatment Choices
Agents mentioned in the algorithm

Alendronate is the first treatment option in all guidance, due to the evidence base,
licensed indications and cost effectiveness.
Alendronate is contraindicated:
• abnormalities of the oesophagus, which delay emptying Deleted: in the presence of
• inability to stand or sit upright for at least 30 minutes Formatted: Bullets and Numbering
Deleted: ,
Deleted: and
It should be used with caution in patients with other upper gastrointestinal disorders and is not recommended in patients with renal impairment (creatinine clearance <35 ml/min). Alendronate is also licensed in the treatment of men and also glucocorticoid-induced osteoporosis. Deleted: Avoidance of
Risedronate is an alternative bisphosphonate. It is licensed in the treatment of post-
Alendronate in known upper GI
Disorder¶

menopausal osteoporosis, glucocorticoid-induced osteoporosis and men. 1.Bijisma. Ann Rheum Dis. 2003; 62: 1033 – 1037¶ Strontium can be used if bisphosphonates are contraindicated or not tolerated.
Severe allergic reactions (DRESS) have been reported. Symptoms include rash, fever, swollen glands and increased white cell count and can cause liver, kidney Deleted:
Deleted: a
Deleted: re
Intraveneous (IV) Zoledronate injection
This is another alternative when oral bisphosphonates are not suitable. It consists of
Deleted: ;
a once yearly IV injection. This should be administered under specialist Deleted: affect
Deleted: V
Deleted: iv
Sub-cutaneous (SC) Denosumab injection
This is an option when none of: oral bisphosphonates, strontium nor iv zoledronate
Deleted: . It is necessary to liaise
with secondary care to arrange this.
are suitable. It consists of a twice yearly SC injection. It is necessary to liaise with Deleted: sc

Author comment OK
Agents not mentioned in the algorithm

Raloxifene
is a further alternative but evidence indicates its efficacy only for vertebral
fracture prevention. It is contra-indicated with a history of venous thromboembolism.
NICE has approved its use in secondary prevention (not primary) after oral
Deleted: only sanctions
bisphosphonates and strontium have been found to be unsuitable. Author comment
OK
Monthly Ibandronic acid is an oral bisphosphonate licensed for postmenopausal
osteoporosis. It has efficacy to prevent vertebral fractures and may be preferred by
some patients.

Compliance/Monitoring
It is accepted that compliance and persistence with medication, particularly the
bisphosphonates is variable. Some patients may persist with the medication but not
properly observe the full administration precautions; others will simply stop the drug
and may not even inform the medical practitioner. Full advice should therefore be
given to all patients starting new medication. Periodic fol ow-up to check for side
effects and encourage concordance has been shown to make a difference.
Patients should be offered an annual medicine use review (MUR) by the community
Deleted: Another aid is to consider
Deleted: What is an MUR?¶
Author comment OK This wasn’t my idea anyway! A medicine use review (MUR) is a service, which can be offered to Other links to resources:
under the Advanced Services of the pharmacy contract.¶ Falls Guideline
For individuals prone to falls, consideration should be given to local or national guidelines (NICE, November 2004) and possible referral to exercise/balance classes. An MUR can be conducted every 12 months and is intended for patients Useful links to the NICE falls guideline are: 1) http://www.nice.org.uk/pdf/CG021NICEguideline.pdf 2) http://www.nice.org.uk/nicemedia/pdf/CG021quickrefguide.pdf 3) Central Lancashire Falls Pathway (available on both NHS Central Lancashire and Lancashire Teaching Hospitals Trust intranets)
Falls
Falls services locally available are:
Primary Care Falls Prevention Service

1) Preston & South Ribble localities:
Community Equipment & Resource Centre
Unit 5
Centurion Court,
Leyland
PR25 3UQ
Telephone: 01772 678042
FAX: 01772 644739
2) Chorley and West Lancashire localities
Old Pharmacy Building,
Ormskirk
DGH Wigan Rd,
Ormskirk
Lancashire
L39 2JW
Tel: 01695 598270
Fax: 01695 598246
Falls Clinics (consultant led)
Dr Agrawal Consultant Physician consulting at:
Falls Clinic (Preston) Brock Day Hospital
Medical Rehabilitation Unit,
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
R2 9HT
01772 524380
And also at:
Falls Clinic (Chorley)
Belmont Day Hospital
Chorley & South Ribble District Hospital
Preston Rd
01257 245540 FAX:01772 524368

References

Bone and Tooth Society, National Osteoporosis Society, Royal College of Physicians
(2002) Glucocorticoid-induced osteoporosis: guidelines for prevention and treatment.
London, Royal College of Physicians.
NICE (2004) Falls: the assessment and prevention of falls in older people. London:
National Institute for Health and Clinical Excellence
NICE (2008) Alendronate, etidronate, risedronate, raloxifene and strontium ranelate
for the primary prevention of osteoporotic fragility fractures in postmenopausal
women.
London, National Institute for Health and Clinical Excellence.
NICE (2008) Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and
teriparatide for the secondary prevention of osteoporotic fragility fractures in
postmenopausal women
. London, National Institute for Health and Clinical
Excellence.
NICE (2008) Final appraisal determination: Alendronate, etidronate, risedronate,
raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility
fractures in postmenopausal women
. London, National Institute for Health and
Clinical Excellence.
National Osteoporosis Guideline Group (2008) Guideline for the diagnosis and
management of osteoporosis in postmenopausal women and men from the age of 50
years in the UK
. Sheffield, NOGG.
NICE (2010) Denosumab for prevention of osteoporotic fractures in post menopausal
women
. London, National Institute for Health and Clinical Excellence.
Locke, G.R et al (1997) Prevalence and clinical spectrum of gastroesophageal reflux:
a population-based study in Olmsted County, Minnesota. Gastroenterology, 112 (5),
pp. 1448-1456.
Bijlsma, J.W.J et al (2003) Glucocorticoids in the treatment of early and late RA.
Annals of the Rheumatic Diseases, 62 (11), pp. 1033-1037.

Dr John F McCann and Louise Winstanley first developed this
document in April 2009. Its basis was the Lancashire Teaching Hospital
secondary prevention guideline, written by JFM.
Membership of the Central Lancashire Osteoporosis work
stream:

Catherine Baines Falls Project Manager NHS Central Lancashire
Dr Kanitkar GP Central Lancashire
Alison Johnson Associate Director Commissioning NHS Central Lancashire
Dr Binymin Consultant Rheumatologist Southport & Ormskirk
Dr John McCann Consultant Physician Lancashire Teaching Hospitals Foundation Trust Mr George McLauchlan Consultant Orthopaedic Surgeon Lancashire Teaching Hospitals Dr Satyendra Singh GP Central Lancashire Claire Wedge Fal s Coordinator NHS Central Lancashire Louise Winstanley, Pharmacist Independent Prescriber, NHS Central Lancashire Nicky Roe Pharmacist Liz Stafford LPC Pharmacist

Source: http://prestonhipday.org.uk/Docs/Central%20Lancs%20Bone%20Health%20_PMD,%20Author%20&%20Librarian%20Changes_%2008-06-11.pdf

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