Brig Royd Osteoporosis Protocol

(Updated December 2014)

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 osteopaenia.

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 - (or FRAX via systmone)

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
  • Low risk (<10%)– lifestyle advice, consider Qfracture repeat after 5 years unless risk factors change
  • Higher risk (>10%) – DEXA referral
  • DEXA PIL
  • 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)

PMR

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
  • Follow scan report recommendations.

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

(1)Alendronate (once weekly)

(2)Risedronate (once weekly prep) – n.b ?often better tolerated and now off patent, but still second line as per NICE – (?likely to change with next guidance)

(3)Consider ibandronate (once monthly)

(4)Strontium (caution re VTE/CVD) – see link below; these patients should be reviewed every 6 months to reassess vascular risks

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

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)

PIL for patients on different treatments in osteoporosis (National Osteoporosis Society)

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

OST002The 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.

OST003The 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.

links for more info

DRUG HOLIDAYS

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 v ertebral 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
  • 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.