Denosumab (Prolia)

Prior to starting Denosumab for osteoporosis 

• Check dose for osteoporosis: 60mg every 6 months
• 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)
• Ensure they had had a dental check
• Supply patients with a patient reminder card
• Send the bellow letter to all patients
• Review after 2 years then yearly
  • Monitor for fracture symotoms: new or uusual pain in hip, thigh or groin
  • Monitor for hypocalcemia: muscle spasms, twitchse, numbness or tigling in fingers or toes or aroun the mouth
  • Monitor for osteonecrosis: chronic ear infections
• Monitor calcium  
  • within 2 weeks after initial dose in renal impairment CrCL<30
  • before each dose (for the 60mg osteoporosis dose) 

Letter for patients before initiation

• 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 exerciseto 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