Denosumab (Prolia) for postmenopausal osteoporosis

Published in Medicine Update

Date published: About this date

Health and medicines information in this article may have changed since the date published. This information does not replace advice from a health professional.

This Medicine Update is for women who are using, or thinking about using, denosumab.

Summary

Denosumab is a new medicine for women with osteoporosis. It is given as an injection once every 6 months.

Denosumab prevents broken bones in women with osteoporosis. It’s not known if denosumab is better at preventing broken bones than other osteoporosis medicines.

Like all treatments for osteoporosis, denosumab has some common side effects. But it’s a new medicine, so not all of its long-term side effects are known.

Some women may prefer a denosumab injection to taking tablets. You will still need to take calcium and vitamin D if these have been prescribed for you.

Contents


What denosumab is

The active ingredient of this medicine is denosumab (pronounced den-os-u-mab).

It is also known by the brand name Prolia.

Denosumab is given as an injection under the skin.

It is a type of medicine called an anti-resorptive. This means that it slows bone loss (thinning of the bones). Denosumab works in a completely different way from other anti-resorptive medicines.


What denosumab is for

Denosumab is used to treat osteoporosis in women who have passed the menopause (postmenopausal women).

Osteoporosis is a condition in which cells in the bone break down faster than new ones can replace them. This causes a gradual loss of bone tissue and makes your bones brittle and prone to breaking easily.

How do you know if you have osteoporosis?

Your doctor will ask you to have a bone mineral density scan if they think you have osteoporosis.

A bone mineral density scan, sometimes called a DEXA scan, measures the density of your bones. It compares your result to the bone density of an average young adult. It is quick and painless, like an x-ray.

The result of your bone mineral density scan is called a T-score. If you have osteoporosis, your T-score will be minus 2.5 or lower. The lower your T-score, the more likely you are to break (fracture) a bone in your hip, spine or wrist. For example, a T-score of minus 3 means that your bones are more brittle — and prone to breaking — than someone with a score of minus 2.5.


Who can use denosumab

You can use denosumab if you have been diagnosed with postmenopausal osteoporosis.

It is available through the Pharmaceutical Benefits Scheme (PBS) for:

  • women who are aged 70 years or older, and
  • have a bone mineral density T-score of minus 2.5 or lower

or

  • women who have passed the menopause, and
  • have osteoporosis, and
  • have had a bone break more easily than expected (for example after a minor bump or fall).

Women who have already broken a bone are more likely to break another bone, so they may benefit most from using medicines for osteoporosis.


How to use denosumab

Denosumab is given as an injection under the skin of your thigh, abdomen, or back of your arm. The injection is given once every 6 months.

Your doctor or nurse can give you the injection. You, or a carer, might be able to give the injection, but some training would be needed first.

If you decide to use denosumab, you should:

  • keep taking calcium and vitamin D if your doctor prescribed these for you
  • talk to your doctor about stopping any other osteoporosis medicines (called anti-resorptives) before your first denosumab injection
  • return any osteoporosis medicines that you no longer need to your pharmacist for safe disposal.

What does denosumab do?

In clinical trials, denosumab slowed the breakdown of bone cells and increased bone mineral density.

In another trial, women were less likely to break a bone if they received denosumab rather than a placebo.

It’s not known if denosumab is any better at preventing broken bones than other medicines for osteoporosis.


Important side effects of denosumab to consider

Ask your health professional about the possible side effects of this medicine before you take it. Always tell them about any changes to your condition if you're taking a new medicine.

To report possible side effects call the NPS Adverse Medicine Events (AME) Line on 1300 134 237 from anywhere in Australia (Monday–Friday, 9am–5pm AEST).

People with questions about their medicines or seeking general information about side effects can call the NPS Medicines Line on 1300 633 424 (Monday–Friday, 9am–5pm AEST).

Rash and itchy, dry and scaly skin are common side effects of denosumab treatment. They can affect the skin around the injection site, but often appear elsewhere. These side effects may clear up on their own, or they may need to be treated by your doctor.

Some women might get a serious skin infection (called cellulitis) caused by bacteria. This is uncommon, but may need to be treated in hospital.

Denosumab may lower the calcium levels in your blood. This is a rare side effect. Most people will not have any symptoms, but you should contact your doctor right away if you have cramps in your muscles or numbness in your fingers or toes.

Denosumab may cause problems with your immune system or pancreas, but this hasn’t been confirmed. The answer will only become clear when denosumab has been used by many more women. But in the meantime, you should tell your doctor if you have any of the following symptoms:

  • fevers or chills
  • hot or tender skin
  • severe, long-lasting abdominal pain.

Rarely, denosumab — and some other medicines for osteoporosis — can cause pain and weakening of bones in the jaw. You can reduce the chance of this happening by taking good care of your teeth and telling your dentist that you are using denosumab.

For a more complete list of possible side effects for Prolia (denosumab), see the consumer medicine information (CMI) leaflet available on our Medicines Finder page.


What else you should know about denosumab

Low levels of calcium in the blood can be a problem for people using denosumab. Your doctor may perform a blood test to check your calcium level before prescribing denosumab.

Most people taking medicines for osteoporosis need to take a calcium supplement as well. Your doctor may also recommend a vitamin D supplement.


Other medicines available for osteoporosis

Talk with your doctor about all the treatment options for osteoporosis.

Like denosumab, most other medicines for osteoporosis work by slowing bone loss. They are called anti-resorptives, but they work in different ways.

The anti-resorptives are:

  • bisphosphonates – including alendronate, etidronate, risedronate and zoledronic acid
  • raloxifene
  • strontium.

Another osteoporosis medicine — teriparatide — works by increasing bone formation.

Are these medicines used in the same way?

All of the osteoporosis medicines listed above are available on the PBS. But they are prescribed in different ways and for different people.

Your doctor will be able to tell you which osteoporosis medicines are available to you through the PBS.

Bisphosphonates

Alendronate (brand names Fosamax, Adronat, Alendrobell and Ossmax), etidronate (Didrocal) and risedronate (Actonel) are tablets. Some are taken daily, while others can be taken weekly or monthly. See the NPS Medicine Update for alendronate.

Zoledronic acid (Aclasta) is given as a drip into a vein in the arm (called an intravenous infusion) once a year. See the NPS Medicine Update for zoledronic acid.

Raloxifene

Raloxifene (Evista) is a tablet that prevents bone loss in a similar way to the hormone oestrogen. It can only be prescribed through the PBS if you have had a bone break due to osteoporosis.

Strontium

Strontium (Protos) comes as a powder that you dissolve in water. It is taken once a day at bedtime, at least two hours after eating or drinking milk. See the NPS Medicine Update for strontium.

Teriparatide

Teriparatide (Forteo) is used by people who have severe osteoporosis. It’s given as an injection once a day into the thigh or abdomen.

Teriparatide can only be prescribed through the PBS if you have had 2 or more broken bones caused by osteoporosis.


How to decide between denosumab and other medicines

A medicine that suits one person may not suit another. You might want to avoid certain side effects or, if the medicine is working well, you may be willing to put up with the possible side effects.

Making a choice between medicines for osteoporosis can be difficult. There are some important questions to ask:

  • What would happen if I didn’t take this medicine?
  • What are the likely benefits of taking this medicine?
  • What risks, such as side effects, should I be aware of?
  • What other treatment options are available?
  • How do I take the medicine?
  • How much is it going to cost?

Think about what matters most to you, and discuss your preferences with your doctor.

Convenience

Some osteoporosis medicines can be difficult to take. You might have to sit upright after you’ve swallowed the tablet (to avoid stomach problems), or remember to take your medicine once each week or month. Denosumab could be an alternative because it’s given as an injection under the skin once every 6 months.

Zoledronic acid is also an injection. It’s given as a drip into a vein once a year. Read more about zoledronic acid.

Less is known about denosumab

Denosumab has not been used to treat osteoporosis for very long, so there is less experience with it than other osteoporosis treatments.

It has some common side effects that can affect your skin, but denosumab will need to be used by many more women before doctors and pharmacists know all of its possible side effects.


What does denosumab cost?

Most medicines prescribed by your doctor are covered by the Pharmaceutical Benefits Scheme (PBS). This means that the Australian Government pays part of the cost of your medicine.

Cost to the Government

The full cost of denosumab to the Australian Government is:

  • $304.87

Each prescription is for a single denosumab injection once every 6 months.

Cost to the individual

If you get denosumab through the PBS, the Australian Government pays most of the cost and you will pay only a part, called the co-payment.

At the time of publication, the co-payment for people who are entitled to get denosumab through the PBS is:

  • $33.30 for people without a concession card
  • $5.40 for concession card holders.

If you're not eligible to get denosumab through the PBS, you will need to pay the full price for a prescription.


Other ways to help osteoporosis

A healthy lifestyle — regular exercise, calcium in the diet, some sunshine and no smoking — is important to help prevent osteoporosis worsening and to manage it.

Exercise

Exercises for osteoporosis can improve fitness, strength and balance. They can also help to prevent broken bones.

What type of exercise?

Examples include brisk walking, tai chi, dancing, aqua aerobics and gentle lifting of weights. Recommendations may differ from person to person, so you should talk to your doctor or a physiotherapist about exercises that suit you.

Avoid exercises that involve twisting, sudden severe movements or bending forward from the spine.These are not suitable if you have osteoporosis.

Calcium

About 3–4 serves of dairy products each day are recommended.

One serve is:

  • 250 mL glass of milk
  • 200 g tub of yoghurt, or
  • 40 g piece of cheese.

Canned fish, tofu, soy beans, other beans and green leafy vegetables such as broccoli and bok choy also contain good amounts of calcium. If you can’t get enough calcium in your diet, then you may need to take a supplement as well.

Vitamin D – sunshine and diet

Vitamin D is also important as it helps the body to absorb calcium. You can get this from short periods in the sun, but take measures to protect your skin between 10am and 3pm. Ask your doctor about how to get enough sunshine safely.

People who get little or no sunlight need a vitamin D supplement.

Vitamin D is also found in oily fish (such as tuna or mackerel), eggs and liver, and is added to some milks and margarines.

No smoking

Smoking can cause the gradual loss of bone tissue – quitting is extremely important, and not just for your bones. Call the Quitline on 131 848 if you want help.

Preventing falls

Reducing your chance of falling again may help you to prevent fractures. Your GP, physiotherapist or occupational therapist can help you work out your risk of falling and advise you about what you can do to keep yourself safe.

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Where to find more information

You can find more information in the consumer medicine information (CMI). This will tell you:

  • who should not use the medicine
  • which other medicines should be avoided
  • how to take the medicine
  • most of the possible side effects
  • the ingredients.

You can get the CMI leaflet for Prolia from:

  • your doctor or pharmacist
  • our Medicines Finder page
  • Amgen, the makers of Prolia (denosumab), on 1800 803 638.

Information over the phone

NPS works with healthdirect Australia to provide the Medicines Line phone service for consumers.

To get more information about any medicine call 1300 MEDICINE (1300 633 424). This service is available from anywhere in Australia, Monday to Friday, 9am to 5pm AEST excluding NSW public holidays.

To report a side effect

Call the NPS Adverse Medicine Events (AME) Line on 1300 134 237, Monday to Friday, 9am to 5pm AEST excluding public holidays.

The AME Line is a service where you can report possible side effects of your medicine and contribute to national medicine safety efforts. Information on medicine-related side effects is passed on to the Therapeutic Goods Administration (TGA) for assessment, but your personal details will remain confidential and your privacy maintained.

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