Drug Treatments for Osteoporosis
What do drug treatments for osteoporosis do and how do they work?
Drug treatments for osteoporosis help to strengthen your bones and reduce your risk of having fractures. They are not given to help with the pain that can occur when bones break. For more information on methods of pain reduction see our Living with osteoporosis page
Most drug treatments for osteoporosis work by slowing down the activity of the cells that break down old bone (osteoclasts). These are known as ‘antiresorptive’ drugs. Some treatments stimulate the cells that build new bone (osteoblasts). These are known as ‘anabolic’ drugs. Others have less well understood ways of working that might combine both of these. The main aim of these drug treatments is to decrease the risk of breaking bones, and drugs are licensed on the basis that they do this. Often treatments will show an increase in bone density as well.
Which drug treatments are available?
|Group/drug name||Brand/product name||Dose and method of administration|
|Alendronate||alendronic acid*||Weekly 70mg tablet|
|Fosamax Once Weekly||Weekly 70mg tablet|
|Fosavance||Weekly tablet containing 70mg alendronate and 2800iu vitamin D3|
|Alendronic Acid Oral Solution||Oral solution (drink) containing 70mg alendronate taken weekly|
|Binosto||Buffered effervescent tablet for oral solution containing 70mg alendronate taken weekly|
|Risedronate||risedronate sodium*||Weekly 35mg tablet|
|Actonel Once a Week||Weekly 35mg tablet|
|Actonel Combi||Weekly 35mg risedronate tablet and daily sachet providing 1000mg calcium and 880iu vitamin D3|
|Actonel||Daily 5mg tablet|
|Ibandronate||ibandronic acid*||Monthly 150mg tablet|
|Three-monthly 3mg intravenous injection|
|Bonviva||Monthly 150mg tablet|
|Bonviva Injection||Three-monthly 3mg intravenous injection|
|Zoledronate||zoledronic acid*||Annual 5mg intravenous infusion|
|Aclasta||Annual 5mg intravenous infusion|
|Denosumab:||Prolia||Twice-yearly 60mg injection given under the skin|
|Strontium Ranelate:**||Protelos||2g sachet of granules, mixed with water and taken daily|
|Selective Oestrogen Receptor Modulator:|
|Raloxifene||Raloxifene hydrochloride*||Daily 60mg tablet|
|Evista||Daily 60mg tablet|
|Parathyroid hormone treatment:|
|Teriparatide||Forsteo||Daily 20 micrograms self-administered injection|
|Hormone therapy or hormone replacement therapy (HRT) for women||Many products available||Various routes of administration are available (tablets, patches, topical gels, vaginal creams)|
|Hormone therapy for men||Many products available||Various routes of administration are available (tablets, patches, implants, injections)|
|Calcitriol||Rocaltrol||Twice-daily 0.25 micrograms tablet|
|* These treatments are generic (non-branded) drugs.|
|**This drug will no longer be available in the UK from August 2017. Read the full story here.|
Click on the highlighted drug names below for more information on each drug treatment for Osteoporosis
What about hormone therapy or hormone replacement therapy (HRT)?
As recently as two decades ago, HRT was the only treatment available for osteoporosis and was prescribed for post-menopausal women to raise the level of the hormone oestrogen after the menopause.
However, over the past 20 years, the range of drug treatments for osteoporosis has greatly increased and there is better understanding of both the benefits and the adverse effects linked with long-term use of HRT. Adverse effects include a risk of breast cancer, strokes and other blood clots and an increased risk of cardiovascular disease. It is because of these that HRT is not generally used as a treatment for osteoporosis.
In postmenopausal women under the age of 60 at high risk of breaking a bone, this treatment may be considered provided that the benefit of reducing fracture risk outweighs any adverse risks.
Rare adverse effects (with bisphosphonates and denosumab)
Are there any new treatments on the horizon?
New drug treatments are being developed for osteoporosis all the time and many are currently undergoing testing. Scientists are looking at other factors that influence the bone-remodelling process. This includes work on the development of a treatment called odanacatib* to inhibit the enzyme cathepsin K, which has a role in the breakdown of bone.
*N.B Development of odanacatib has been discontinued as research has shown and increased risk of stroke. (Oct 2016)
Studies are also looking at a drug called romosozumab, which inhibits the action of sclerostin, a protein that affects bone formation.
At the same time, existing drugs are also being manufactured in new forms. Preparations of parathyroid hormone treatment, currently available only as an injection, may in the future be delivered in different ways including, for example, by inhaler, nasal spray or patch.
Are there any drug treatments for osteoporosis that are no longer used?
As advances have been made in the understanding of osteoporosis and new, improved treatments have been developed, some older drug treatments have become unavailable. This may be because they are not so effective in reducing the risk of fracture as the newer drug treatments, and unacceptable side effects have occasionally been identified.
Didronel PMO is an example of the former while calcitonin is no longer used because of long-term health risks.
At one time sodium fluoride was prescribed for people with osteoporosis but it was discovered that, although it increased bone density, it actually led to an increased risk of fracture.
Making decisions about drug treatments
Should I take a drug treatment?
There are many factors that will influence decisions about whether you take a treatment for osteoporosis. Some of these will affect your doctor’s decision and recommendations and other factors relate to how you feel about taking a drug treatment for your bones.
- Your doctor will have recommended a drug treatment because you have osteoporosis and have a high risk of fractures. This decision is usually made on the basis of a fracture risk assessment. This assessment (particularly useful in older people) will have established that your risk of breaking a bone in the next 10 years is significantly raised and as a result a drug treatment to reduce that risk is recommended. Occasionally younger people may be advised to take a drug treatment for their bones, though such advice would usually be based on specialist opinion.
- You may be worried about potential side effects and long-term risks of taking a drug treatment and you may be struggling to balance these against the benefits for your bones. As with any medicine for any condition, osteoporosis drugs can potentially cause side effects. The likelihood of experiencing a side effect will depend on a variety of factors, and you should remember that if the drug treatment is taken correctly most people will not experience any problems at all. It may be helpful to find out more about the side effects that worry you as often they can be an initial response to the drug and will go after a short time. If you experience them it may be worth persevering.
- You may have read about potential long term risks, and these may be putting you off starting or continuing with the treatment that your doctor has prescribed. Again, familiarise yourself with these, as the risk of such problems occurring is often very small. Fear of side effects need not put you off trying a treatment. The risk of these occurring is usually very much smaller than the risk of you having a fragility fracture if you don’t have a treatment.
Some people with osteoporosis may decide not to take a treatment because they have personal health beliefs about taking conventional drugs or because the side effects or risks associated with treatments seem to them to outweigh their personal benefits. They or their doctor may decide there is no medical treatment appropriate for them. If this is the case for you, there may be other practical steps you can take to help protect against broken bones.
Although research has shown changes to diet and exercise have some effect, these benefits have not always been sustained. Unfortunately, there have been few research trials comparing the effectiveness of drug and non-drug approaches in altering the risk of fracture. As yet, complementary therapies have not been shown to reduce the risk of breaking a bone. Lifestyle changes are important anyway, but you will then have to decide whether to take a drug treatment by balancing the risks and benefits of both approaches.
Which drug treatment should I take?
People often ask ‘which drug treatment is best?’ The answer is that, in terms of effectiveness, broadly they probably all reduce the risk of fracture to about the same extent. There are a number of factors that will affect the choice of treatment. These include the following factors:
Which type of drug will suit you: tablet, drink, injection or infusion ‘drip’?
Drug treatments for osteoporosis are given in a variety of ways. Sometimes a particular route will be more appropriate than others. If, for example, you already suffer with an irritated gullet (food pipe) or have swallowing problems because of another medical problem, you could take a drug given via a drip in your arm or an injection, which bypasses the digestive tract altogether.
Potential side effects
Some of the bisphosphonate tablets can cause inflammation to the oesophagus, injectable bisphosphonates sometimes cause flu-like symptoms for a few days, and raloxifene (Evista) and strontium ranelate (Protelos) slightly increase the risk of blood clots.
Sometimes other medical problems you have might make particular drug treatments unsuitable.
It is worth remembering that you may not be offered a choice when a treatment is prescribed but if you struggle with a particular treatment the good news is that there are others you can try.
The important thing is that you take a treatment that you are happy with because you will probably need to take it for at least five years.
Local or NHS guidance, based on what is cost-effective
The treatment your doctor is able to offer you will be influenced by local or NHS guidance. In the UK, national guidance is produced by NICE* (the National Institute for Health and Care Excellence). This is an independent organisation that the government developed to get rid of the ‘postcode lottery’ whereby some drugs and treatments were available in some parts of the country but not in others. NICE aims to give independent advice about which treatments should be available on the NHS in England and Wales to make sure that people have the same access to treatment and care wherever they live.
* In Scotland, guidance is provided by the Scottish Medicines Consortium and the Scottish Intercollegiate Guidelines Network.
NICE ensures that a treatment:
- benefits the people taking it
- will help the NHS to meet its targets, for example by reducing the number of hip fractures
- is cost-effective or value for money.
Your doctor may also be restricted by local or country-based guidance that influences the drug treatment offered to you.
Whether a cheaper generic drug is available rather than a branded version
Most people are prescribed alendronic acid – the generic (non-brand) version of alendronate (Fosamax) – for osteoporosis. This is because generic medicines contain the same active treatment as branded ones but are cheaper for the NHS.
Even with medicines that you can buy, such as paracetamol, there is often a big price difference between generic and branded products. You may worry that because it is cheaper it is not so effective or is more likely to cause side effects, but in the UK there are strict quality controls before a product licence is granted for brandname and also generic versions of medicines. This means generic and brand-name versions of a drug will contain the same active medication although the additives, coatings and so on could be different.
I am a man with osteoporosis. Which drug treatments can I take?
Not all drug treatments for osteoporosis have a specific licence to be used in men, although many of the treatments that are used in women are also used in men with a high risk of fracture or if they have already broken a bone. The exceptions to this are raloxifene (Evista) and some types of hormone therapy (HRT), which are only appropriate for women. Your doctor may also be restricted by country-based guidance that influences the drug treatments that can be offered to men.
I am a younger person with osteoporosis. Should I take a drug treatment?
As explained in Scans and Tests, if you are a premenopausal woman or a younger man (under 50) with low bone density, you are unlikely to break a bone in the near future and so will not usually need a drug treatment. You may be given lifestyle advice and should also be advised to discuss your risk of having a fragility fracture with your doctor when you are older.
There are, however, exceptions to this advice. If you have broken bones easily and have a bone density below the average for your age, are using high-dose glucocorticoid tablets, or have a hormonal disorder that affects your oestrogen or testosterone levels, a drug treatment may be recommended.
Your doctor will usually refer you to a specialist such as a rheumatologist (joints and bones), an endocrinologist (hormones) or a gynaecologist (women’s health). One of the reasons for caution in using drug treatments, such as bisphosphonates, in younger people is that these drugs often stay in the bones for a long time. This may cause problems later in life, and in women of child-bearing age they could potentially affect the development of a baby in the womb.
Low bone density in younger people may be caused by other contributing factors such as the eating disorder anorexia nervosa. The disorder causes low levels of the hormone oestrogen or testosterone, and this can be detrimental to bone. If this applies to you, you will need support and help to manage the underlying problem. In women and girls, an increase in body weight will help to restore normal menstrual periods and hormone levels, which should in turn help to prevent further bone loss.
Hormone replacement may be given if you have no menstrual periods because of low body weight, but any potential benefits are unproven. If you are in your adolescence and still growing, hormones may not be recommended as they could potentially affect normal bone growth. You may be recommended to take calcium and vitamin D supplements if you are not getting enough of these important nutrients.
If you are a woman or man with coeliac disease, you will have an increased risk of osteoporosis. You will be given advice about gluten-free foods and healthy eating, which will help to increase the absorption of minerals and vitamins. As with other conditions that affect the absorption of food in the body, calcium and vitamin D supplementation may be recommended.
What about children with osteoporosis – should they take a treatment?
Osteoporosis can very occasionally affect children either because of an underlying condition (secondary osteoporosis) or because of a rare form of primary osteoporosis called idiopathic juvenile osteoporosis. Expert guidance suggests that children will only be diagnosed with osteoporosis if they have low bone density for their age as well as fragility fractures and will usually only be given drug treatments if they have had multiple fractures. Their management and care will come from a team with specialist expertise in paediatric bone health.
As with many medical conditions, drugs for osteoporosis have not been licensed for children. However, in some cases, after an individual assessment of your child, your specialist may decide to use smaller amounts of the drugs that are used for adults, especially if your child has been severely affected with fractures. Monitoring of this treatment should take place within a specialist centre. As juvenile osteoporosis can spontaneously improve, especially during puberty, many specialists adopt a ‘watch and wait’ approach where possible. Calcium and vitamin D may also be prescribed.
Licensing of drug treatments and medicines
Before a drug can be sold in the UK, a marketing authorisation (formerly product licence) from the Medicines and Healthcare Products Regulatory Agency (MHRA) is required. The MHRA will only issue a marketing authorisation if:
- clinical trials have proved that the drug successfully treats the condition it was developed for
- the drug’s effects are acceptable, and
- the drug meets high safety and quality standards.
Wherever possible, doctors will try to prescribe a licensed drug for your condition. However, doctors may sometimes prescribe a drug for use outside the terms of its marketing authorisation (such as in men or younger people with osteoporosis). This is called prescribing an unlicensed drug.
Doctors may prescribe an unlicensed drug if:
- there is no available licensed product
- in their judgement, that drug is the best one available to treat your condition.
If there are no appropriate licensed drugs, a specialist at your hospital with expert knowledge of a specific condition may consider prescribing an unlicensed drug.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the organisation in the UK that makes sure drugs and medical devices work and are acceptably safe.
For how long should I take my osteoporosis drug treatment? What happens to my bones when I stop?
The length of time you need to stay on a drug treatment varies depending on your individual circumstances. For some people, short-term treatment may be required, while for others, particularly those at higher fracture risk, a minimum of five years, and probably longer, may be needed. Not surprisingly, drug treatments reduce the risk of breaking a bone most effectively while you are taking them.
When you stop treatment the benefit will start to wear off, though the speed at which the effects of a drug wear off differs between treatments.
The effects of bisphosphonates last the longest; some may continue to have an effect for several years after treatment is stopped.
Bear in mind that some specific drugs (e.g. parathyroid hormone therapy) are given for a limited time period. Usually this is because research studies have obtained results on the effectiveness and safety of the drug treatment for that length of time, and so their licence reflects this.
Why shouldn’t I just keep taking the drugs on a long-term basis?
This is because there is a small risk of developing serious but very rare adverse effects with some drug treatments for osteoporosis (the bisphosphonates and denosumab). These are osteonecrosis of the jaw and atypical (or unusual) fractures of the thigh bone.
The risk of these occurring is extremely small but, in the case of atypical fractures, appears to increase the longer you take the treatment, although more research is needed to confirm this. As already explained, however, even if you are taking treatments for a longer period of time, if you have a high risk of fracture, this usually outweighs the very small risk of such problems occurring. For more information please see our factsheets Osteonecrosis of the jaw (ONJ) and drug treatments for osteoporosis and Atypical (unusual) thigh bone fractures and drug treatments for osteoporosis
For some people, however, shorter-term treatment may be all that is required. For instance, if you are taking glucocorticoids (‘steroids’) or treatments for cancer called aromatase inhibitors (which reduce bone strength), an osteoporosis drug might be prescribed only while you take these other medicines.
I have been taking an osteoporosis drug for many years. Do I need to go back to discuss my treatment with my doctor?
Yes. It is now considered good practice for doctors to review all osteoporosis drugs after patients have been taking them for a number of years to make sure that the drugs are still needed, that they aren’t causing side effects and that the benefits of continuing to take the drug continue to outweigh any potential harm.
At a treatment review, your doctor will decide whether you need to continue to take the drug or whether you can stop taking it. Formal recommendations have been produced to help doctors decide how long to prescribe the bisphosphonates (e.g. alendronic acid) and when to perform a review, because these are the drugs that have been linked with either osteonecrosis of the jaw or atypical fractures.
Denosumab has recently been linked with these rare problems so a formal review every few years would be recommended for this treatment too. For more information please see above.
How will my doctor decide whether I need to continue with my drug treatment at my review? Will I need a bone-density scan?
Just like when you started your treatment, your doctor will assess whether you are still at significant risk of breaking a bone. Your doctor may recommend you have a bone-density scan to help assess your risk.
If you are considered to be at high risk (e.g. if you have a history of having broken one or more bones in the past and have other risk factors for osteoporosis), your doctor may recommend that you continue with your osteoporosis drug treatment without the need for a bone-density scan.
I have heard a ‘pause’ (sometimes called a "drug holiday") in treatment is a good idea? What does this mean and how does it work?
A ‘pause’ in treatment means your doctor stopping your medicine and, after a while (usually one to three years), reassessing whether or not to restart it. The reason for restarting will usually be that your risk of fracture has been reduced because of treatment but isn’t low enough to permanently stop taking a drug treatment altogether.
These pauses in treatment have only been recommended to date for bisphosphonates because these drugs continue to have an effect on bone and provide some benefit even after they are stopped. As with any decision to stop an osteoporosis medicine, a pause in your treatment would probably not be recommended if you are considered to have a high fracture risk.
If you are older or have had fragility fractures already – especially compression fractures in your spine or a previous hip fracture – you may be considered to be at high risk and your doctor would probably recommend continuing treatment.
How will my doctor decide whether and when to restart a bisphosphonate?
This will depend on your individual situation and the drug you were taking. Assuming nothing has changed in terms of your health, some doctors may simply restart the bisphosphonate drug treatment after one to three years. Sometimes your doctor will need to, once again, consider all your risks for fracture including your history of broken bones, and may possibly need to refer you for a bone-density scan. It is important to remember a scan is useful only if it will help with treatment decisions.
Getting the most out of your drug treatment
Taking your osteoporosis drugs as prescribed and following the instructions carefully will ensure you get the most from your medication. Understanding why the instructions are important can be helpful.
Get enough of the medicine to make a difference
Continue to take your tablets and take them regularly. Missing the odd tablet will probably not have an impact on your bone health in the long run but you should avoid this if you can. If you are taking a weekly tablet such as alendronic acid, it is useful to choose a day that you will remember every week, for example the day your bins are emptied or a memorable day such as a Sunday. If you continually forget or struggle to take your medication, it would be sensible to speak to your doctor about other treatment options that you may find easier to take.
Reduce the risk of side effects by taking your drug treatment correctly
Bisphosphonate tablets, for example, must be swallowed whole with a full glass of water while staying upright (sitting or standing), thus ensuring that the tablet does not stick in your gullet, where it can cause irritation.
Make sure your osteoporosis drug is properly absorbed
Some drug treatments for osteoporosis (strontium ranelate and bisphosphonates, such as alendronic acid) are very poorly absorbed, so if you eat or drink anything apart from water around the time you take your medicine the drug won’t be absorbed and therefore won’t work to strengthen your bones. To maximise this absorption process, it is important that you observe the fasting instructions that are described in the leaflet that comes with your medication. If you are taking a calcium supplement it is particularly important that you do not take it at the same time of day as these osteoporosis drugs, as calcium will prevent their absorption.
Make sure you get all the nutrients your bones need as well as your osteoporosis drug treatment
Eat a well-balanced, calcium-rich diet. Your doctor may prescribe calcium and vitamin D supplements as well as osteoporosis drug treatments if your intake is thought to be low. Supplements don’t reduce your fracture risk like a drug treatment but you do need to get enough calcium and vitamin D to maintain your bone strength.
Be confident your drug treatment is working
This can be difficult because the main purpose of these treatments is to prevent fractures, rather than to relieve pain or symptoms. However, you can be confident that all of the licensed drug treatments for osteoporosis have been clinically tested and research has proven they reduce the risk of breaking bones. Having a bone-density scan provides some information but doesn’t tell you everything about your bone strength or show conclusively whether a drug is working or not. If you have a fracture while on treatment it does not necessarily mean that the drug is not working – no drug is 100% effective. However, if you continue to break bones, talk to your doctor; depending on your circumstances, a different drug may be suggested.
Clinical trials on new drugs usually go through a series of stages. First, a small number of healthy volunteers try a new drug, then a few hundred people with the condition test it to see whether it works and what side effects occur. This information is used to develop the dosage and method of taking the drug. After this, a larger number of people take the drug over a longer period of time, and, if the drug is proven to work and is safe and tolerable, it will be licensed either by the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency for doctors to use. In the final stage, further studies are carried out once the drug is available on prescription to look at long-term side effects. Drug trials are monitored by regulatory authorities and, if there are doubts over the safety of a drug, the trial may be suspended or stopped.