Osteoporosis

This guideline applies to the identification and management of Osteoporosis in adults aged 18 and over.

• Fractures
  • Direct suspected hip fractures to the Emergency Department, not Minor Injury Units
     
  • Suspected closed fractures other than hip can be directed to Minor Injury Units

• Malignancy
  
  
• Atypical femoral fractures can occur in patients on bisphosphonates
  
  • They can occur after minimal or no trauma with some patients experiencing unilateral or bilateral lateral thigh or groin discomfort, often associated with Xray changes weeks to months before complete femoral fracture.

• Suspected cord compression
  • Cauda equina syndrome: direct to the Emergency Department
     
  • Metastatic spinal cord compression: arrange same day admission via AcuteGP

1. Check whether there are any risk factors for Osteoporosis

2. Assess the patient’s dietary calcium intake, consider using a calcium calculator tool CGEM Calcium Calculator (ed.ac.uk)

and risk assess for vitamin D deficiency.

3. Assess the FRAX (Fracture Risk Assessment Tool) score to estimate 10 year probability of a major osteoporotic fracture:

frax.shef.ac.uk/FRAX/tool.aspx?country=1

• FRAX is rarely indicated if the patient has severe frailty or a life expectancy less than 10 years
• FRAX may underestimate the risk of fracture with vertebral fractures, multiple fractures or the very elderly

4. Consider a falls risk assessment, including review of prescribed and over the counter medication.

5. If the patient is already on bisphosphonates and presents with unilateral or bilateral lateral thigh or groin discomfort, consider atypical femoral fractures in the differential.

FBC, UE, LFT, TFT, Bone profile, Testosterone in men, Immunoglobulins, Protein electrophoresis, Urine Bence Jones Protein, Coeliac, as clinically indicated

Vitamin D if vitamin D deficiency is suspected

Organise a DEXA if:

• The patient has had a non-vertebral fragility fracture for a baseline result before starting treatment (this will be typically done by the new Fracture Liaison Service)

or

• Immediate or high risk of fracture on FRAX

or

• Re-calculating bone density after a specified period

Organise a Vertebral Fracture Analysis if:

• The patient is 50 to 80 years of age and has had a no or low trauma vertebral fracture

Organise a plain vertebral film X-ray if:

• The patient is over 80 years of age and has had a no or low trauma vertebral fracture

If malignancy suspected and there are no features of cauda equina or metastatic cord compression, consider an urgent whole spine MRI, or if not spinal, a nuclear bone scan

Imaging for suspected impending atypical femoral fractures

If no other cause is suspected, organise a DEXA of bilateral femurs (available on ICE).

If other causes are suspected consider a plain film X ray.  Typical features to look out for on plain imaging include localised periosteal reactions of the lateral cortex or generalised increase in cortical thickness of the diaphysis.

Adopt a shared decision making approach with the patient.

1. Lifestyle factors and written information on Osteoporosis Osteoporosis fact sheets and booklets (theros.org.uk):

a) Weight bearing and balance exercises as appropriate

b) Smoking cessation

c) Reduce alcohol; 3 units or more per day can affect bone health

2. Maintain calcium (1g) and vitamin D (800 IU) per day, usually in combined supplements:

If vitamin D deficiency has been identified, correct as per the Royal Osteoporosis Society loading regimens before maintenance therapy.  ros-vitamin-d-and-bone-health-in-adults-february-2020.pdf (theros.org.uk)  This is particularly important before starting zolendronate or denosumab.

Check Bone profile one month after completing the loading dose in case of unmasked primary hyperparathyroidism.

3. Osteoporosis medications:

Bisphosphonates

Useful shared decision making tool TA464 Patient decision aid on bisphosphonates for treating osteoporosis (nice.org.uk)

a) First line: Alendronic acid 70mg once weekly

b) Second line: Risedronate 35mg once weekly

c) Third line: Ibandronic acid

Contraindications (non exhaustive list)

• Creatinine clearance – alendronic acid less than 35 ml/min, risedronate less than 30 ml/min
• Unable to sit upright for 30 minutes after taking or delayed gastric emptying
• Pregnancy or breastfeeding
• Child bearing potential

Cautions (non exhaustive list)

• Known upper gastrointestinal problems including peptic ulcer disease, Barrett’s oesophagus
• Within 1 year of major upper gastrointestinal surgery or bleeding
• High risk of osteonecrosis of the jaw and external ear canal, including cancer, chemotherapy, steroids, history of dental or periodontal disease or invasive dental procedures.  Patients should seek dental review if poor dental status before commencing.

Safety netting (non exhaustive list)

• Correct taking of the tablet (sitting upright for 30 minutes after taking, avoiding food or milk based drinks)
• Seek medical attention if any unusual thigh, hip or groin pain to consider atypical fractures
• Seek medical attention if any jaw pain, ear pain, discharge or recurrent ear infections due to rare reports of osteonecrosis of the jaw and external ear canal
• Review at 3 months to check on side effects and compliance 

If there are side effects, consider changing the dose to every second week, an alternative bisphosphonate or changing to monthly Ibandronic acid. 

Current guidance on when to reassess:

If high risk (including 75 years or over or previous hip/vertebral fracture) continue alendronic acid for up to 10 years and risedronate for 7 years.

Otherwise reassess DEXA:

If T score less than -2.5, continue treatment and reassess DEXA every 3-5 years

If T score greater than -2.5, stop treatment and reassess DEXA after 2 years

Denosumab

If have a contraindication to, or unable to tolerate or comply to bisphosphonatesfor secondary prevention

Or

If have a contraindication to, or unable to tolerate or comply to bisphosphonates for primary prevention and are:

• 65 to 69 years with a T score of less than -4.5 with one risk factor or less than -4.5 with two risk factors
• 70 to 74 years with a T score of less than -4.5, less than -4.0 with one risk factor and less than -3.5 with two risk factors
• over 75 years with a T score of less than -4.0 with one risk factor and less than -3.0 with two risk factors

Risk factors for Denosumab prescribing are parental history of hip fracture, more than 4 units of alcohol per day and Rheumatoid arthritis

Licensed for osteoporosis in postmenopausal women, men, bone loss related to long term systemic steroids in adults, bone loss related to hormone ablation in men with prostate cancer at increased fracture risk

Dental examination is required before prescribing if any risk factors for osteonecrosis of the jaw or poor dental status.

           Contraindications (non exhaustive list)

• Hypocalcaemia – ensure this is corrected with calcium and vitamin D.  Monitor calcium before each dose and 2 weeks after
• Unhealed open soft tissue wounds in the mouth – delay the start of treatment until this has resolved
• Younger than 18 years

 Cautions (non exhaustive list)

• Creatinine clearance less than 30 ml/min or on dialysis – obtain rheumatology advice and renal advice if on dialysis
• Risk factors for osteonecrosis of the jaw or external ear canal including cancer, steroids, chemotherapy, radiotherapy to head and neck, smoking, dental and periodontal disease, invasive dental procedures. 

Regime and monitoring

1. Check UE and Bone profile prior to each dose
2. Subcutaneous injection 60mg once every 6 months
3. If risk of hypocalcaemia, check UE and Bone profile within 2 weeks of the dose
4. If the patient is unable to tolerate it is acceptable to stop after the initial injection, however avoid stopping longer treatments abruptly or discontinuing for a drug holiday due to rapid bone density loss on stopping.  Delays in repeat injections should be no longer than one month. Refer to Osteoporosis clinic for a Zolendronate infusion to be given 6 months after stopping Denosumab
5. If denosumab needs to be discontinued, such as falling creatinine clearance, discuss with Rheumatology. 

Safety net (non exhaustive list)

           Seek medical attention if:

• any unusual thigh, hip or groin pain to consider atypical fractures
• any jaw pain, ear pain, discharge or recurrent ear infections due to rare reports of osteonecrosis of the jaw and external ear canal
• hypocalcaemia symptoms

     Current guidance on when to reasses

     Review at 5 years, reassess for secondary causes and request a DEXA and seek rheumatology advice.

   
      HRT

      Benefit is lost quickly when HRT has stopped

      Secondary Care Prescribed Medications                

• IV Zolendronate    
• Romosozumab for post menopausal women with severe osteoporosis who have had     an osteoporotic fracture and high risk of further fractures
• Teriparatide
• Raloxifene (only reduces the risk of vertebral fractures)

4. Patients on corticosteroids:

• If long term corticosteroids (prednisolone 5mg or over for 3 months or equivalent) and over 50 years, commence bone protection and organise a DEXA to see if required long term.  If under 50 years, ask for Rheumatology advice.

• If medium or low dose long term corticosteroids are started, organise FRAX.  If FRAX is near to but below intervention threshold, repeat FRAX and DEXA 2 years after starting treatment.

5. Vertebral pain relief:

• Use pain relief at the lowest possible dose for the shortest period of time, considering paracetamol and/or weak opioids only.  Only consider stronger opioids if needed for short periods of time, advising caution with dependence, tolerance, driving, delirium, nausea and constipation. 
   
• If already on opioids, explain the risks of continuing opioids and take a shared decision making approach to safe withdrawal of opioids.  Consider an opioid contract if needed.
   
• Consider pain support services where needed.
   
• Encourage mobilisation as soon as possible.

Fracture Liaison Service

Severe pain with stable vertebral fractures

Consider discussion with spinal surgery if unremitting pain with stable vertebral fractures that is severe and unmanageable after 48 hours.

Refer to Rheumatology Osteoporosis Clinic if:

• There is uncertainty about diagnosis or management
• Fracture occurs on treatment
• 2 or more previous vertebral fractures
• If stopping denosumab, so that IV Zolendronate can be given 6 months after stopping
• Very low bone density T score less than -3.5
• Treatment is contraindicated, not tolerated or poor compliance
• Women of child bearing potential, pregnancy or breast feeding with osteoporosis
• Post menopausal women with severe osteoporosis, an osteoporotic fracture and are at high risk of further fractures
• Men with osteoporosis
• CKD stage 4 or worse
• Secondary care medication needs to be considered
• Following 5 years of Denosumab
• Atypical femoral fracture on treatment
• Significant deterioration in bone density despite oral bisphosphonates

Discuss with Rheumatology if:

• Denosumab needs to be discontinued such as falling creatinine clearance at any stage or other reason after the second injection or more

Discuss with Renal if:

• Considering Denosumab and the patient has severe renal failure or is on dialysis

RCHT Rheumatology Advice & Guidance (cornwall.nhs.uk)

For professionals:

ros-vitamin-d-and-bone-health-in-adults-february-2020.pdf (theros.org.uk)

frax.shef.ac.uk/FRAX/tool.aspx?country=1

For patients:

Osteoporosis fact sheets and booklets (theros.org.uk)

TA464 Patient decision aid on bisphosphonates for treating osteoporosis (nice.org.uk)

drug-treatments-for-osteoporosis-denosumab.pdf (windows.net)

CGEM Calcium Calculator (ed.ac.uk)

References

1. National Institute Of Clinical Excellence.  Clinical Knowledge Summaries.  Osteoporosis – Prevention Of Fragility Fractures.  April 2023
2. Basingstoke, Southampton and Winchester District Prescribing Committee.  Osteoporosis Medical Management Of Men And Women Who Have (Or At Risk Of) Osteoporosis. February 2017
3. Royal Osteoporosis Society.  Vitamin D And Bone Health: A Practical Clinical Guideline For Patient Management.  February 2020.
4. National Institute Of Clinical Excellence.  Denosumab For The Prevention Of Osteoporotic Fractures In Postmenopausal Women.  October 2010.