Osteoporosis (Guidelines)

• Refer to: SIGN142 Osteoporosis QRG: risk factors to treatment:

• Alternatively: Introduction | Osteoporosis: assessing the risk of fragility fracture | Guidance | NICE
• Also consider: UK National osteoporosis Guideline Group: Summary of main recommendations | NOGG (Note some divergence to SIGN, eg, DXA intervention thresholds. NHS Highland guideline follows: SIGN142 Osteoporosis).
• Also refer to: Royal Osteoporosis Society - Osteoporosis Charity UK (theros.org.uk).

• Presence of risk factors for fracture
  • Refer to SIGN142 Osteoporosis for a complete list
  • AND calculated FRAX OR Q-fracture risk for major fractures of 10% or more
• Fragility fracture and age >50 year
  • (Recent fragility fractures will be automatically invited or advised treatment via our fracture liaison service FLS* for those women >75 year, , see below)
• Aromatase inhibitor treatment being commenced and age <65 year
  • See below for age >65 year
• Steroid (glucocorticoid) therapy being commenced and age <65 year
  • Equivalent to >5 mg prednisolone/day for >3 months
  • See below for those age >65 year
• Coeliac patients >10% FRAX risk
  
  • OR at any FRAX risk if persisting symptoms on gluten-free diet for 1 year
  • OR poor adherence to gluten-free diet and weight loss >10% or BMI <20 kg/m²
• Spinal injury affecting mobility, especially where there is current or later plan to weight-bear
• Hyperparathyroidism
• Anorexia nervosa
• Hormone antagonist therapy
  • Eg, GnRH analogue for prostate cancer, endometriosis, etc
• Transplantation
• Cystic fibrosis
• Other indications can be considered on an individual basis, especially if DXA will aid patient management

Highland Fracture Liaison Service (FLS)

HLS operates by identifying patients who have attended Highland A+E departments and found to have likely fragility fractures.

Note: FLS will miss those fractures that occurred outside Highland or when a GP refers patients, eg, for vertebral fractures or delayed diagnosis / presentation fractures, because they do not present to A+E.

DXA scan referral:

Appropriate referrals will be undertaken as per agreed protocol: DXA Referral Criteria 2015 (NHS Highland intranet access required).

• DXA Referral Form (NHS Highland intranet access required)
• Please send completed referral forms to: X-ray department, Ross Memorial, Dingwall, IV15 9QS

• Vertebral fracture, if fragility and age >50 year
  
  • Also refer for DXA because severe spinal osteoporosis can be targeted with more effective first line therapy than bisphosphonates, eg, teriparatide
• Steroid therapy being commenced and age >65 year
  • Equivalent to >5 mg prednisolone/day for >3 months
• Aromatase inhibitor therapy being commenced and age >65 year
• Fragility fracture of any type among women >75 year

Instead of DXA scanning first we recommend that the above patients may commence an oral bisphosphonate, see Formulary: Bisphosphonates used in osteoporosis for a 5-year course of treatment if their renal function allows.

• Bisphosphonate therapy should be discontinued if the oral steroid therapy or aromatase inhibitor is discontinued.
• After 5 years of Bisphosphonate therapy, request a DXA scan in these individuals. Do NOT continue bisphosphonate therapy beyond 5 years without a DXA scan.
• All individuals prescribed an oral bisphosphonate should also have adequate calcium and vitamin D intake, either from diet and sunshine or from supplementation.  Avoid calcium within 4 hours of taking a bisphosphonate.
• If your patient feels they do not wish/or are unable to commence bisphosphonate therapy without DXA scan confirmation, please refer them for DXA scanning by the normal route.

Refer to BNF individual SmPCs, Highland formulary, SIGN 142 and NOGG guidelines for detailed prescribing guidance.

First line: Oral bisphosphonates

• Alendronate or risedronate are first line therapies to manage high fracture risk associated with osteoporosis due to low cost, and favourable benefit/ risk.
  There are some situations where other therapies may be considered in a first line setting. Eg, teriparatide (includes parathyroid biosimilars) for severe spinal osteoporosis, romosozumab for severe osteoporosis of the spine and high non vertebral fracture risk and zoledronic acid following recent hip fracture (SIGN142 Osteoporosis QRG).

Second line:

• Where oral bisphosphonates are not tolerated or are unsuitable
  Eg, denosumab, zoledronic acid, ibandronate or romosozumab

Other options in specific circumstances:

• HRT, strontium ranelate or raloxifene

Some treatments require specialist assessment for initiation and implementation and this is accessed via Rheumatology referral. This includes zoledronic acid, teriparatide and romosozumab.

All the above therapies rely on the patient being replete in calcium and vitamin D3. Consider prescribing a combined calcium/vitamin D supplement or, if a patient’s oral intake of calcium is sufficient, vitamin D3 only.

Consider investigating the following groups

• Among men without an obvious cause for osteoporosis (e.g. steroids, androgen deprivation, rheumatoid arthritis, etc)
• Those with DXA Z-scores at the AP spine (L1-4) or hip site of -2 or less
• Those with rapid loss of BMD
• Those with treatment failure, despite good adherence to treatment

Investigations may include U+Es, LFTs, TSH, calcium, vitamin D, phosphate, ferritin, FBC, plasma viscosity, myeloma, coeliac and in other selected cases may include testosterone, prolactin, cortisol, etc.

Oral bisphosphonates take 6 months to provide fracture risk reduction against vertebral fractures and longer for non-vertebral fractures (18 to 24months).

Therefore, patients who fracture within the first 2 years of treatment would usually be advised to continue treatment.

Those who fracture after 2 years are advised to have DXA (FLS should identify these patients).

It is good practice to check compliance to bisphosphonates and also consider vitamin D status. Based on DXA or alternatively a patient’s reason for non-compliance it may then be appropriate to switch to parenteral treatment.

NICE give figures in pictogram form for different 10-year FRAX derived major fracture risks. This presents the absolute benefits and risks of treatment: Bisphosphonates for treating osteoporosis patient decision aid (nice.org.uk)

The ORB calculator was designed by Professor Stuart Ralston, Edinburgh University and is available on-line or IOS. This provides an estimate of the absolute benefits of fractures prevented as well as harms. This uses a 5-year fracture risk time period. Therefore, if using FRAX figures please remember to divide by 2 to convert from 10-year risk to 5-year risk. Eg, FRAX major risk of 20% would become 10% for the ORB calculator. ORB Calculator (ed.ac.uk)