Brig Royd Osteoporosis Protocol

(Updated June 2016)

Osteoporosis is defined as 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

DEXA definition - A ‘T-score’ of ≥ 2.5 standard deviations (SD) below the young adult mean has been classified as osteoporosis by the World Health Organisation (WHO). Overall fracture risk increases two-fold per unit SD decrease in BMD and this relationship is even greater for hip fractures and BMD measured at hip sites. In terms of T scores, a score of -2.5 or less confirms osteoporosis, between -1 and -2.4 confirms osteopenia.

Identifying patients at high risk of osteoporosis

Clinical risk factors:

 Age

 Gender

 Low BMD

 Previous fragility #

 Parental history of hip #

 BMI < 19

 Hormonal – premature menopause, prolonged amenorrhoea (not related to PCOS or pregnancy), use of depot provera > 5 years. Includes men post-orchidectomy/androgen deprivation/hypogonadism

 Drugs – oral steroids (any dose of oral corticosteroids for >3/12 OR 1 g Prednisolone or equiv. lifetime dose.) GnRH analogues, arimidex, anticonvulsant therapy, Glitazones, PPIs

 Lifestyle – smoking and alcohol intake (>3 units/day), immobility,

 Medical conditions – rheumatoid arthritis, IBD, Malabsorption, cystic fibrosis, hyperthyroidism, hyperparathyroidism, Cushing’s syndrome, vit D insufficiency, COPD, Type 1 DM, Chronic renal and hepatic disease.

Consider using Qfracture - http://www.qfracture.org/index.php (or FRAX via SystmOne)

Q fracture is well validated in UK and is more accurate in predicting fracture risk. It takes into account more variables (but cannot take into account BMD like FRAX). It has been shown to be accurate up to 85years (whereas FRAX underestimates risk in 75+, heavy smokers, high alcohol intake and high dose steroid use)

FRAX automatically links to NOGG guidance and when BMD is entered into FRAX, the NOGG output shows whether the patient’s individual fracture risk places them above or below a treatment threshold. Primary Prevention

 Women aged < 45 with recent premature menopause = HRT until 52 (unless contraindicated). Not for DEXA unless other risk factors

 Women aged > 50 and Men aged > 65 who have clinical risk factors:

 FRAX calculation

o Low risk (<10%)– lifestyle advice, consider Qfracture repeat after 5 years unless risk factors change

o Higher risk (>10%) – DEXA referral

 DEXA PIL http://www.patient.co.uk/health/dexa-scan

 Frail/>75 with clinical risk factors

 Falls assessment

 Check Vit D and calcium and consider further investigation if an underlying cause suspected. (e.g FBC, ESR, Electrolytes, Bone profile, TFTs, PTH, ALP, Coeliac screening)

 Treat without DEXA (as per 2° prevention)

Individuals > 65 or hx of prior fragility fracture - DEXA not required use bisphosphonate and calcium & vitamin D

Individuals < 65 - Start calcium & vitamin D, DEXA scan and consider bisphophonate if T score less than -1.5

Secondary prevention

(1) Women aged > 50 or men aged >65 with low trauma fracture

 DEXA referral

 Follow scan report recommendations

(2) If abnormal DEXA but no history of #

 FBC, ESR, Electrolytes, Bone profile, TFTs, PTH, ALP, Coeliac screening, Oestrodiol (amenorrhoeic pre-menopausal), testosterone (men), Vit D Lifestyle advice; to be given at any opportunity (reduce alcohol, stop smoking, improve BMI if low and encourage weight bearing exercise.

Prescribe a calcium and vitamin D supplement to those with insufficient dietary intake or limited exposure to sunlight. Patients can assess their dietary intake with the International Osteoporosis Federation calcium calculator

https://www.iofbonehealth.org/news/are-you-getting-enough-calcium-use-new-calculator-find-out

As a quick guide, consuming 600mls milk provides adequate daily calcium of 720 mg ( daily recommendation 700mg

Treatments in order of preference: (from NOGG and NICE)

(1) Alendronate or risedronate once weekly preparation

(2) Consider referral for IV zolendronate or denosumab

(3) Strontium (caution re VTE/CVD) – see link below; these patients should be reviewed every 6 months to reassess vascular risks; should never be used in any patient with vascular disease.

(4) Raloxifene - not licensed for primary prevention, but is for secondary prevention in certain circumstances ( BNF osteoporosis treatment)

(5) HRT is indicated for women with premature menopause for bone protection

All plus calcium/vit D – Calderdale formulary recommends generic coleclciferol 400unit/Calcium carbonate 1.5g chewable tablets BD (equivalent of Adcal D3)

If none of above tolerated – refer to rheumatology for advice. (?denosumab/teriparatide)

Taking bisphosphonates

It is important to counsel patient about how to take this medication; there is a low concordance rate due to side effects.

 A minimum of 30 minutes should be left between taking bisphosphonates and taking food or drink , and other medication such as calcium or antacids. Orange juice and coffee can reduce absorption by as much as 50%

 Avoid in hypocalcaemia, severe CKD ( e GFR<35), and in patients who cannot remain upright for 30 minutes after taking.

 Consider with caution in patients with upper GI problems . (Patient info leaflet on bisphosphonates to be given to patient - http://patient.info/health/bisphosphonates )

Repeating DEXA - In line with PACE guidance (&BMJ) patients with osteoporosis should have a scan every 3 years and those with osteopaenia every 5 years. (please create patient alert with date of next DEXA and consider adding reminder to repeat prescriptions)

Brig Royd Codes to use.

(1) Referral for DEXA = /dexa

(2) Fragility fracture = /fracture

(3) T score = /dexat

(4) Osteoporosis = /osteo

QOF 2015/16; unchanged ( but remember to code DEXA results if osteoporotic as well as fragility fracture)

OST001 The contractor establishes and maintains a register of patients: 1. Aged 50 or over who have not attained the age of 75 with a record of a fragility fracture on or after 1 April 2012 and a diagnosis of osteoporosis confirmed on DXA scan, and 2. Aged 75 years or over with a record of a fragility fracture on or after 1 April 2012 OST002 The percentage of patients aged 50 or over who have not attained the age of 75, with a fragility fracture on or after 1 April 2012, in whom osteoporosis is confirmed on DXA scan, who are currently treated with an appropriate bone-sparing agent.

OST003 The percentage of patients aged 75 or over with a fragility fracture on or after 1 April 2012, who are currently treated with an appropriate bone-sparing agent.

References;

NICE, March 2016, CKS,Prevention of Fragility Fractures; Summary. http://cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!scenario

SIGN,2015. Management of osteoporosis and prevention of Fragility Fractures.

Nice 2012; Osteoporosis; Assessing the risk of Fragility Fractures. http://www.nos.org.uk/page.aspx?pid=264&srcid=234

BMJ 2016:352 Bisphosphonates beyond five years (10 min consultation) DRUG HOLIDAYS

It is uncertain how long patients should take bisphosphonates. No randomised controlled trials have evaluated the effectiveness of treatment breaks.

The following guidance is taken from the National Osteoporosis Society and seems to be in line with current practice.

Bisphosphonates have a long half-life in bones and their effects continue for some years after stopping.

Due to concerns about atypical femoral fractures and osteonecrosis of the jaw a drug holiday should be considered after 5 yrs of treatment.

Some patients may require long term treatment (eg patients with multiple vertebral fractures, treatment with high dose steroids, or patients with very low BMD at outset).The benefits are likely to outweigh the risks.

NOGG guidance suggests a review of patients after 5 years treatment with alendronate or risedronate. This review should include the re-assessment of fracture risk in treated individuals using the FRAX tool, combined with a repeat DEXA as necessary, before deciding if continuing treatment is appropriate.

Arrange DEXA after 5 yrs of treatment.

 If BMD same/improved/>2.5 withdraw treatment for 2-3 years then reassess with DEXA

 Fracture risk should be reassessed after any new fracture or every 2 years. Consider restarting treatment if fracture risk increases.

 If fracture risk is still above the intervention threshold; continue treatment for another 5 yrs.

DENOSUMAB

This is now under shared care scheme and GP responsibilities include

 Ensure compliance with vitamin D/ calcium

 Have recall system for 6 monthly injection

 Check calcium levels before 6 monthly injection

 Early treatment of skin infections/cellulitis which is an increased risk.

 Delay any invasive dental treatment until just before 6 monthly injection

 Refer back to specialist after 5 years.