Drug information Drugs for osteoporosis Drugs for osteoporosis This leaflet provides information on drugs for osteoporosis and will answer any questions you have about the treatment. Arthritis Research UK produce and print our booklets entirely from charitable donations.
Why are these drugs prescribed? There are many drugs used to treat osteoporosis. Most of these drugs are prescribed to reduce your risk of bone fractures. As well as drug therapy, treatment for osteoporosis involves attention to lifestyle risk factors, such as improving your diet, stopping smoking, moderating alcohol intake and doing more exercise. Together these can prevent further bone deterioration and can often improve its strength, reducing the risk of fractures.
Arthritis Research UK Drugs for osteoporosis What s inside? 2 Table 1: Drugs that are used to treat osteoporosis 3 What drugs are used to treat osteoporosis? Bisphosphonates Teriparatide and parathyroid hormone Raloxifene Calcitonin Strontium ranelate Hormone replacement therapy (HRT) Calcium and vitamin D Denosumab 7 What else should I know about drugs for osteoporosis? How long do these treatments take to work? Will I need any special checks while having treatment? Can I take other medicines alongside these treatments? Will treatment affect vaccinations? Can I drink alcohol while having treatment? Do treatments affect pregnancy? Do they affect breastfeeding? 9 Where can I get more information? 1
Arthritis Table 1 Drugs Research that are UKused to treat osteoporosis Painkillers Drug (brand name) How taken How often Bisphosphonates Alendronate (Fosamax, Fosavance) By mouth Daily or weekly Risedronate (Actonel) By mouth Daily or weekly Ibandronate (Bonviva, Bondronat) By mouth By injection into the vein Monthly Every 3 months Pamidronate (Aredia) By injection into the vein Every 3 months Zoledronate (Aclasta) By injection into the vein Annually Parathyroid hormone Teriparatide (Forsteo) By injection under the skin (self-administered) Daily usually for 18 months (2 years maximum) Parathyroid hormone (Preotact) By injection under the skin (self-administered) Daily for 2 years Other osteoporosis treatments Denosumab (Prolia) By injection under the skin (subcutaneous injection) Twice a year Raloxifene (Evista) By mouth Daily Calcitonin (Miacalcic) (only used to prevent acute bone loss if you re immobilised following an osteoporotic fracture) By injection under the skin or into a muscle Daily or twice daily for a few weeks only Strontium ranelate (Protelos) By mouth (mixed with water) Daily Hormone replacement therapy (HRT) Most forms of HRT may be used for the treatment of post-menopausal osteoporosis. By mouth, patches, topical gels, implants (HRT contains oestrogen. Women who have not had their uterus (womb) removed will also need to take a progestogen.) Often daily, but less frequently with some patches and implants Calcium and vitamin D (usually used in addition to other treatments) Calcium and vitamin D in combination By mouth Daily or twice daily Calcium only By mouth Daily or twice daily Vitamin D only By mouth As recommended by your doctor
Arthritis Research UK Drugs for osteoporosis 3 What drugs are used to treat osteoporosis? Bisphosphonates There are several different bisphosphonates and, although they all work in a similar way, there are important differences between them which need to be considered. How and when do I take bisphosphonates? Treatment by mouth These bisphosphonates are generally poorly absorbed by the body and can cause irritation of the gullet (heartburn), so it s very important to follow the detailed instructions for taking your medication: Take it on an empty stomach with a glass or two of plain tap water. Other drinks may prevent the drug being properly absorbed by the body. You shouldn t eat anything or take any other medication or supplements for at least 30 minutes afterwards (45 minutes for Bonviva). This is to help ensure the medication is effectively absorbed. You will need to stay upright (sitting, standing or walking) for up to an hour afterwards. This will help to prevent the medication flowing back from your stomach and causing heartburn. You should not lie down before you have eaten. Intravenous treatment Pamidronate is given by intravenous infusion (a drip into a vein). This takes about an hour and the infusion can be repeated every three months. Zoledronate is also given by intravenous infusion but is only given once a year, in an infusion lasting 20 minutes or more. Ibandronate can be given by mouth or intravenously every three months from a pre-prepared syringe. This injection takes seconds. Bisphosphonates are generally very well tolerated. You can get indigestion symptoms (e.g. abdominal pain, distension, dyspepsia, diarrhoea or constipation) with the oral preparations but the risk is reduced if you strictly follow the manufacturers instructions. Less common side-effects include: itchy rashes or photosensitivity (rash on exposure to sunlight) a sore mouth flu-like symptoms (more common with intravenous treatments) bone pain (more common with intravenous treatments) muscle pain headaches. You should report any side-effects to your doctor or rheumatology nurse and the drug may be stopped if necessary. There are three very rare side-effects: 1. Osteonecrosis of the jaw is a condition where, following invasive dental procedures, an area of bone is exposed through the gum and a small amount of bone dies. This condition is much more common if you have cancer, are having chemotherapy or if you have severe, recurrent dental infections and are having dental treatment. 2. There s been a suggestion of a tiny increase in the occurrence of cancer 3
Bisphosphonates work by slowing bone loss; many people will have an increase in bone density after 2 5 years. of the oesophagus (gullet) in people taking bisphosphonates by mouth for more than 3 5 years. Although the evidence is mixed, you may still be taken off the treatment after five years to further lessen the risk. 3. Some people taking alendronic acid have developed painful, unusual partial fractures in the upper, outer region of the thigh bone (femur) below the hip. It s usually confirmed by a special diagnostic scan. The risk appears to increase the longer you ve been taking alendronate, and may be more likely if you re also having corticosteroid treatment or have diabetes. However, this side-effect is still extremely rare. Your doctor will review your treatment from time to time to make sure the benefits of the treatment still outweigh the risks. What else should I know about bisphosphonates? It s important not to develop deficiencies of calcium and vitamin D when taking bisphosphonates, as this can lessen their effect. You may be prescribed a daily supplement of calcium and vitamin D. Most specialists limit treatment with oral bisphosphonates to five years to minimise the risks of rare long-term side-effects. However, some people will need more prolonged treatment. During bisphosphonate therapy you re advised to maintain good oral hygiene and have regular dental check-ups. If you re expecting to have dental work it s usually best if this can be completed before starting on bisphosphonates. However, it s not usually necessary to stop your bisphosphonates if you do need dental treatment later on. If in doubt, check with your doctor. Teriparatide and parathyroid hormone Parathyroid hormone is naturally produced by four small glands in your neck. This hormone helps regulate calcium levels in your blood. Teriparatide is very similar to the naturally-occurring hormone. It reduces the risk of fractures by helping new bone to form. It s usually used only in severe cases of osteoporosis, particularly in those with vertebral (spine) fractures, in people with very low bone density, or when other treatments haven t been effective. 4
Arthritis Research UK Drugs for osteoporosis How and when do I take teriparatide and parathyroid hormone? Teriparatide comes in a syringe that looks like a pen. You can inject yourself subcutaneously (under the skin), usually in the abdomen or thigh. Your healthcare team will show you how to do this. It s usually given every day for 18 months and for a maximum of two years. A synthetic form of parathyroid hormone itself is also available. Like teriparatide, it comes in a pen syringe and can be self-administered subcutaneously once a day. Teriparatide is usually very well tolerated. Possible side-effects include: gastrointestinal side-effects e.g. nausea, reflux symptoms palpitations dizziness headache fatigue depression slight irritation at the injection site occasional troublesome bone pain. What else should I know about teriparatide and parathyroid hormone? It must not be given if you have high calcium levels or if you have overactive parathyroid glands, skeletal cancers or Paget s disease. It shouldn t be used if you ve had radiotherapy to your bones, for example as part of breast cancer treatment. Raloxifene Raloxifene is used to treat spinal osteoporosis in post-menopausal women following a fracture. It has some of the same beneficial effects on bone as oestrogen, but with fewer risks. For example, while it increases the density of the vertebrae (the bones of the spine) and reduces vertebral fracture rates, it also reduces the risk of breast cancer. However, there s a very small increased risk of deep vein thrombosis (DVT) and it isn t usually suitable for older women. How and when do I take raloxifene? It s taken in 60 mg tablets once a day. A small minority of women experience uncomfortable hot flushes, leg cramps, swollen ankles and flu-like symptoms. Less common side-effects include blood clots in the legs or inflammation in the leg veins. Your doctor will probably suggest an alternative treatment if you re already having menopausal symptoms since raloxifene can increase these. This treatment isn t used if you have a history of leg clots, womb cancer or liver disease. Calcitonin In the UK, calcitonin is no longer available for the long-term treatment of osteoporosis. Calcitonin may be given by injection either under the skin (subcutaneously) or into a muscle (intramuscular injection) as a short-term treatment to prevent acute bone loss if you re suddenly immobilised 5
following an osteoporotic fracture. In this case, it will only be used for 2 4 weeks. Possible side-effects include nausea, vomiting, diarrhoea, abdominal pain, flushing, dizziness, headache, musculoskeletal pain and taste disturbance. Strontium ranelate Strontium ranelate works by both speeding up the formation of new bone tissue and slowing the breakdown of old bone material. Trials have shown that strontium ranelate reduces the risk of spine and hip fractures in people who ve already had a fracture, as well as those with low bone density. Strontium ranelate is only available to people who can t use other osteoporosis treatments, and isn t suitable for people who have a history of heart disease or circulatory problems such as stroke, heart attack, obstruction of the blood flow in the arteries or uncontrolled high blood pressure. How and when do I take strontium ranelate? Strontium is taken as a powder (strontium ranelate) which you mix with water. It s taken once daily, at least 2 hours before or after food. Most people find it convenient to take it 2 hours after their evening meal and before going to bed. You should avoid products containing lots of calcium (e.g. milk, yogurt) after taking strontium. Some people taking strontium develop mild diarrhoea which may prevent longer-term use. Occasionally strontium causes nausea or rashes and there s a small increased risk of DVT. You will have regular checks for any signs of heart or circulatory problems. Hormone replacement therapy (HRT) For many years, HRT was the only established medication for the prevention and treatment of post-menopausal osteoporosis. However, its use was always limited by its side-effects. Now that other, non-hormonal treatments have been introduced, HRT is mainly used as a short-term therapy for women up to the age of 60 with increased fracture risk who also have troublesome menopausal symptoms, as HRT can be very effective in relieving these symptoms. Side-effects include a small increased risk of breast and ovarian cancer, deep vein thrombosis (DVT), heart attacks, strokes and memory impairment though the risk of these is greater in women over the age of 60. These risks are balanced by a reduction in the risk of hip fracture and colon cancer. Calcium and vitamin D It s usually recommended that you try to get enough calcium from your diet without using supplements. However, combined calcium and vitamin D supplements are often given alongside 6
Arthritis Research UK Drugs for osteoporosis other treatments for osteoporosis. If you re a woman over the age of 70 and take a calcium supplement on its own, it s very important not to have more than the recommended daily intake, as this may have a negative effect on heart health. This seems to apply only to calcium supplements, not calcium from food. People on osteoporosis treatments may find a daily calcium intake of 1000 1200 mg helpful. A pint of milk a day, together with reasonable amounts of other foods that contain calcium, should be enough. Skimmed and semi-skimmed milk contain more calcium than full-fat milk. Other sources of calcium include leafy green vegetables, beans and chickpeas, and some nuts and dried fruits. For more information see Arthritis Research UK booklet Diet and arthritis. Vitamin D alone is now easily available in a range of doses. Vitamin D deficiency is quite common in people of all ages. It s believed that getting enough vitamin D will help reduce fracture risk, as well as promoting better response to other treatments for osteoporosis. Denosumab Denosumab works by restricting a protein called RANK ligand, which occurs naturally in the body. Restricting this protein limits the activity of cells that break down bone (osteoclasts) and therefore increases bone mass and strength. Denosumab is recommended for postmenopausal women who can t take bisphosphonates and also in men who develop osteoporosis as a result of treatments for prostate cancer which reduce levels of testosterone. How and when do I take denusomab? It s given as an injection under the skin twice a year. Common possible side-effects include: occasional skin infections (cellulitis) at the site of injection back pain arm and leg pain urinary tract infections constipation rash. Less common side-effects include low blood calcium (your blood levels will be checked before you start treatment) and, rarely, osteonecrosis of the jaw. Each year in the UK there are around 70,000 hip, 120,000 spine and 50,000 wrist fractures linked to osteoporosis. 7
What else should I know about drugs for osteoporosis? How long do these treatments take to work? Treatments for osteoporosis take time to work because bone renewal is a slow process. However, reduction in fracture risk is often evident after 6 12 months. It s important that you continue treatment for as long as your doctor tells you to the aim is to prevent fractures so you won t be able to feel the effect your treatment is having. It s becoming more common to stop treatment after 3 5 years to minimise the rare complications sometimes seen in those having longer treatment. Your doctor or specialist will discuss whether this is appropriate for you. The beneficial effects of many treatments for osteoporosis last a very long time, perhaps for years. You may, therefore, have what s called a treatment holiday while your progress is monitored. You shouldn t worry that the benefits of the drugs will be lost during this time. Will I need any special checks while having treatment? You re likely to have a bone density scan before you start treatment, although this isn t necessary for everyone for example, older people who have suffered fractures from a simple fall may not need a scan. Once you ve started treatment you may be monitored by one of the following: bone density scans, usually of the spine and/or hips, every 2 5 years depending on your individual circumstances blood and urine tests to detect special markers that show how well your bone is renewing itself (these show a response to treatment earlier than a bone density scan, but aren t yet so widely available). If you re taking HRT, you ll have regular checks of blood pressure and mammograms (breast x-rays). Can I take other medicines alongside these treatments? Other medicines can usually be taken alongside these treatments, but with bisphosphonates you should avoid taking all other pills and tablets for at least four hours afterwards. You should discuss any new medications with your doctor before starting them. Will treatment affect vaccinations? There s no reason why you shouldn t have vaccinations during treatment. Can I drink alcohol while having treatment? Excess alcohol intake is one of the risk factors which can lead to osteoporosis. But alcohol is unlikely to interfere with any of the medications used to treat the condition. 8
Arthritis Research UK Drugs for osteoporosis Do treatments affect pregnancy? Osteoporosis usually affects older people, but not always. Most of the drugs are licensed for use in post-menopausal women. However, younger women do sometimes require treatment and the possible risks and benefits will need to be weighed up. You should discuss this with your doctor. Bisphosphonates Women of childbearing age should ideally avoid taking bisphosphonates, although this isn t always possible. These drugs are known to cross the placenta and so may pass to the unborn child. Teriparatide and parathyroid hormone We don t yet know the effect of these treatments in pregnancy. However, as they re only used in the most severe forms of progressive osteoporosis, they re unlikely to be recommended for women of childbearing age. Raloxifene and strontium ranelate These drugs aren t recommended for use in pre-menopausal women. They both slightly increase the risk of DVT, which is already increased in pregnancy. There s no information regarding the effect of strontium on the baby s development and it should therefore be avoided in pregnancy wherever possible. As always, the risks and benefits of treatment need to be considered carefully and discussed with your doctor. Do they affect breastfeeding? Bisphosphonates You shouldn t breastfeed if you re taking bisphonsphonates as they re passed in breast milk in small amounts and could potentially affect the growth of the baby s bones. Teriparatide and parathyroid hormone We don t yet know how these treatments affect breastfeeding. However, as their use is confined to the most severe forms of progressive osteoporosis, they re unlikely to be recommended for younger women. Strontium ranelate You shouldn t breastfeed if you re taking strontium ranelate. Where can I get more information? Arthritis Research UK is the charity leading the fight against arthritis. We do this by funding high-quality research, providing information and campaigning. We publish over 60 information booklets which help people to understand more about their condition, its treatment therapies and how to help themselves. If you would like any further information about drugs for osteoporosis, of if you have any concerns about your treatment, you should discuss this with your doctor, rheumatology nurse or pharmacist. 9
Get involved! You can help to take the pain away from millions of people in the UK by: volunteering supporting our campaigns taking part in a fundraising event making a donation asking your company to support us buying products from our online and high-street shops. To get more actively involved, please call us on 0300 790 0400 or email us at enquiries@arthritisresearchuk.org or go to www.arthritisresearchuk.org A team of people contributed to this booklet. It was written by Dr Tom Palferman, who has expertise in the subject. It was assessed at draft stage by consultant rheumatologist Dr Dipak Roy. An Arthritis Research UK editor revised the text to make it easy to read, and a nonmedical panel, including interested societies, checked it for understanding. An Arthritis Research UK medical advisor, Dr Luke Gompels, is responsible for the content overall. Please note: We have made every effort to ensure that this content is correct at time of publication, but remember that information about drugs may change. This information sheet is for general education only and does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet that comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects that may be relevant in your particular case. Arthritis Research UK Copeman House, St Mary s Court, St Mary s Gate, Chesterfield, Derbyshire S41 7TD Tel 0300 790 0400 calls charged at standard rate Registered Charity England and Wales No 207711, Scotland No SC041156 Arthritis Research UK 2014 Published May 2014 2274/D-OSTEO/14-1 This leaflet has been produced, funded and independently verified by Arthritis Research UK. www.arthritisresearchuk.org