Biphosphonates

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Prior to starting Biphosphonate 
  1. Assess dose
    • Alendronic acid
      • Postmenopausal osteoporosis: alendronic 70mg weekly
      • Osteoporosis in men: 10mg daily
      • Prevention and treatment of corticosteroid-induced osteoporosis in postmenopausal women not recieving HRT: 10mg daily
    • Ibandronic acid
      • Osteoporosis: 150mg every month
      • Reduction of bone damage in bone metastases in breast cancer: 50mg daily
    • Risedronate
      • Postmenopausal osteoporosis to reduce risk of vertebral or hip fractures: 5mg daily or 35mg weekly
      • Prevention of osteoporosis (including corticosteroid-induced osteoporosis) in postmenopausal women: 5mg daily
      • Osteoporosis in men: 35mg once weekly
    • NB Can also be prescribed in people who are taking high doses of oral corticosteroids (more than or equivalent to prednisolone 7.5 mg daily for 3 months or longer)
    • Consider prescribing HRT to women who have a premature menopause (menopause before 40 years of age) to reduce the risk of fragility fractures and for the relief of menopausal symptoms
  2. Correct hypocalcaemia
  3. Ensure they had had a recent dental check
  4. Bisphosphonates should not be given to women of child bearing capacity unless specialist advice has been sought as they are incorporated into the skeleton and the potential effects on future pregnancies are unknown. 
  5. Inform patient that the medication must be
    • taken on an empty stomach as their absorption is affected by food, drink, and other drugs
    • the tablet must be swallowed whole and taken with a glass of plain water (at least 200 mL); it must not be sucked or chewed because of a potential for oropharyngeal ulceration.
    • it should be taken while in an upright position.
    • the person must not lie down for at least 30 minutes after taking the medication.
    • the medication must not be taken at bedtime or before getting up in the morning.
    • once weekly preparations should be taken on the same day each week.
    •  Risedronate 
      • should be taken before breakfast; however, if this is not practical, it can be taken between meals or in the evening at the same time each day, with strict adherence to the following instructions (to ensure that it is taken on an empty stomach):
      • Before breakfast — must be taken at least 30 minutes before the first food, other medicinal product, or drink (other than plain water) of the day.
      • Between meals — should be taken at least 2 hours before or at least 2 hours after any food, other medicinal product, or drink (other than plain water).
      • In the evening — should be taken at least 2 hours after any food, other medicinal product, or drink (other than plain water).
    •  Alendronate
      •  must be taken at least 30 minutes before the first food, other medicinal product, or drink (other than plain water) of the day.
  6. Send initiation letter to all patients (see below)
  7. Prescribe Calcium & Vitamin D
    • If the person's calcium intake is adequate (700 mg/day)
      • prescribe 10 micrograms (400 international units) of vitamin D (without calcium) for people not exposed to much sunlight
    • If calcium intake is inadequate
      • Prescribe 10 micrograms (400 international units) of vitamin D with at least 1000 mg of calcium daily (= evacal 1od)
      • Prescribe 20 micrograms (800 international units) of vitamin D with at least 1000 mg of calcium daily for elderly people who are housebound or living in a nursing home (= evacal 2 od)
Review after 2 years then yearly
  • Monitor for fracture symotoms: new or unusual pain in hip, thigh or groin
  • Monitor for hypocalcemia: muscle spasms, twitchse, numbness or tigling in fingers or toes or around the mouth
  • Monitor for osteonecrosis: chronic ear infections
  • Perform blood test annually for calcium  & vitamin D 
  • Review the need for continuing treatment with bisphosphonates after 3–5 years
    • For people who remain at high risk of an osteoporotic fragility fracture, continue treatment with alendronic acid for up to 10 years, and risedronate for up to 7 years. This includes people with any of the following risk factors:
      • Age over 75 years
      • A previous hip or vertebral fracture
    • In other people, arrange a dual-energy X-ray absorptiometry (DXA) scan and consider
      • Continuing treatment if the T-score is less than -2.5. Reassess their fracture risk and bone mineral density (BMD) every 3–5 years
      • Stopping treatment if the BMD T-score is greater than -2.5. Reassess their fracture risk and re-measure BMD after 2 years
  • For people who sustain an osteoporotic fracture while on bone-sparing treatment, 
    • check adherence to treatment and exclude secondary causes for osteoporosis.
    • If other underlying causes are excluded, consider referral to a specialist for advice on drug treatment.
    • Drug treatment is recommended for at least 5 years to reduce the risk of further fractures 
Letter to be sent to patients by email / by post / printed before initiation
  • Your oncologist/haematologist wishes to start you on a biphosphonate
  • This is a type of treatment which can help to
    • Prevent or control bone thinning
    • Reduce the risk of your bones breaking
    • Lower the level of calcium in your blood (hypercalcaemia)
    • Reduce pain
  • You are advised to ensure you follow the following lifestyle advice:
    • Take regular exercise to improve muscle strength:
      • Walking, especially outdoors, as this will increase exposure to sunlight, increasing vitamin D production.
      • Strength training (such as weight training) of different muscle groups (for example hip, wrist, and spine).
      • A combination of exercise types, for example balance, flexibility, stretching, endurance, and progressive strengthening exercises. 
    • Eat a balanced diet as this may improve bone health.
    • Stop smoking if needed, as it is a risk factor for fragility fracture
    • Drink alcohol within recommended limits, as alcohol is a dose-dependent risk factor for fragility fracture.
  • A side effect called medication-related osteonecrosis of the jaw (MRONJ) (bone damage in the jaw) has been reported in between 1 and 6 of every 100 people having this type of treatment. MRONJ is more common in people who have had Denosumab treatment for three to four years. Any teeth causing problems or likely to need extraction in the future should be removed before starting Denosumab, having dental extraction or a dental implant placed can result in MRONJ. This is a lifelong risk even after the Denosumab is stopped. In order to reduce the risk of developing MRONJ, please follow the advice below.
  • Before you start treatment:
    • It is vital that you have a dental assessment with your normal dentist
    • Inform them that you will be starting the treatment
    • Any teeth judged to be problematic and unlikely to recover should be removed
    • Your dentist should ensure that dentures are well fitting as ill fitting dentures can increase the risk of MRONJ
    • It is recommended that you are prescribed high fluoride toothpaste to use at all times
    • If you do not have a dentist please contact the NHS England Dental Helpline on 0300 311 2233 to register
    • Maintain good oral hygiene. This includes:
      • Brushing your teeth and tongue after each meal using a soft toothbrush and a gentle stroke
      • Flossing gently once a day
      • If your gums bleed or hurt, avoid the affected area
      • Keeping your mouth moist by rinsing often with water
  • There is a very small increased risk of fractures in patients receiving this medication long-term. Please report any new or unusual thigh, hip or groin pain during your treatment
  • Report any signs of hypocalcaemia to the surgery: muscle spasms, twitchse, numbness or tigling in fingers or toes or around the mouth
  • Other resources of information and support
    • The National Osteoporosis Society provides support and information to people affected by osteoporosis, and works to improve public understanding of osteoporosis.
    • Healthtalkonline has a large collection of videos and transcripts of people's experiences of health and illness, including osteoporosis. There are also short articles for people with osteoporosis and the general public.
    • NHS has a health encyclopaedia which has a printable article on Osteoporosis
Biphosphonates audit
  • Patients taking risedronate for > 7 years 
  • Patients taking alendronic acid for > 10 years  

Reasoning: 

  • For people who remain at high risk of an osteoporotic fragility fracture, continue treatment with alendronic acid for up to 10 years, and risedronate for up to 7 years. This includes people with any of the following risk factors:
    • Age over 75 years.
    • A previous hip or vertebral fracture.
  • In other people, arrange a dual-energy X-ray absorptiometry (DXA) scan and consider:
    • Continuing treatment if the T-score is less than -2.5. Reassess their fracture risk and bone mineral density (BMD) every 3–5 years.
    • Stopping treatment if the BMD T-score is greater than -2.5. Reassess their fracture risk and re-measure BMD after 2 years.

https://cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!scenarioRecommendation:4

Long term steroid treatment
  • Patients on more than prednisolone 7.5 mg, dexamethasone 1.125mg, hydrocortisone 30mg, methylprednisolone 6mg daily for 3 months or longer

Reasoning: Consider prescribing a bone-sparing agnet to people who are taking high doses of oral corticosteroids (more than or equivalent to prednisolone 7.5 mg daily for 3 months or longer)

https://cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!scenarioRecommendation:4

 

 

prednisolone Alendronic acid Ibandronic acid Risedronate

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