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Drug treatments for osteoporosis

Building stronger bones

Drug treatments for osteoporosis June 2013.indd 1 7/19/2013 2:35:01 PM

What is osteoporosis?

Osteoporosis occurs when the struts which make up the mesh-like structure within bones become thin causing them to become fragile and break easily, often following a minor bump or fall. These broken bones are often referred to as 'fragility fractures'. The terms ‘fracture’ and ‘broken bone’ mean the same thing. Although fractures can occur in different parts of the body, the wrists, hips and spine are most commonly affected. It is these broken bones or fractures which can lead to the pain associated with osteoporosis. Spinal fractures can also cause loss of height and curvature of the spine.

Strong dense bone

Fragile osteoporotic bone

This leaflet covers specific information on drug treatments. If you would like more general information on drug treatments for osteoporosis, such as how to decide which drugs to take, please ask us for a copy of our publication All about osteoporosis.

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Treatments for osteoporosis aim to reduce the risk of broken bones occurring and there is a range of drug treatments which have been shown to do this. Most drugs work by slowing down the activity of the osteoclast cells that break down old bone. These are known as anti-resorptive drugs. Some treatments stimulate the cells that build new bone, these are known as anabolic drugs; others have less well understood ways of working which might combine both of these. All of these drugs help increase bone strength and lower the risk of fracture by about 50 per cent.

This leaflet explores the range of treatments that are available for people with osteoporosis, providing information such as how they are taken and possible side effects.

The aims of treatment

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The bisphosphonates are a widely used family of drug treatments used to reduce the risk of broken bones in people with osteoporosis. Bone is constantly being worn away and rebuilt by specialist bone cells. This is called bone remodelling. Bisphosphonates slow down this process. They inhibit the cells that break down bone (osteoclasts) and allow the cells that rebuild bone (osteoblasts) to work more effectively. Like most drug treatments, bisphosphonates are not taken to relieve the pain of osteoporotic fractures but to improve bone strength and reduce the risk of fractures. Some members of this family are available in tablet form and others via an injection or infusion through a vein directly into the blood. The latter may be particularly useful in those people who find that the tablets cause irritation to the digestive tract.

Cyclical etidronate (Didronel PMO) was the first bisphosphonate to be used in the treatment of osteoporosis and although it is still sometimes prescribed, newer, more potent bisphosphonates such as alendronic acid or alendronate (Fosamax) and risedronate (Actonel) are more commonly used.

Bisphosphonates

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Key to tables

F = Post-menopausal women M = MenThese symbols are a guide to whether drugs are licensed for men or women. Sometimes, however, men will be prescribed drugs licensed for womenS = These treatments have been shown to reduce the risk of broken bones in the spineH = These treatments have been shown to reduce the risk of a broken hip GIOP = These treatments have been shown to reduce the risk of broken bones in people who have osteoporosis caused by corticosteroid medication

For a comprehensive list of possible side effects please see the Patient Information Leaflet which accompanies your medication.

A licensed drug has been checked for safety and effectiveness and can be prescribed by a doctor for a specific condition.

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.

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Alendronate

Available as Alendronic acid*Dose 70mg weekly tablet or 10mg daily tabletLicensing details F M S H GIOP

Available as Fosamax once weekly

Dose 70mg weekly tablet

Licensing details F S H

Available as Fosamax

Dose 10mg daily tablet

Licensing details F M GIOP S H

Available as Fosavance

Dose Weekly tablet containing 70mg alendronate & 2800 iu vitamin D3

Licensing details F S H (for postmenopausal women with osteoporosis at risk of vitamin D insufficiency).

Method of administrationRegardless of dose and how often it is taken, alendronate must be taken at least 30 minutes before the first food or drink (other than plain tap water) of the day. These instructions are important because alendronate will only be effective if taken on an empty stomach. Tablets must be swallowed whole and taken with a glass of plain water. It is necessary to stay upright (sitting, standing or walking) for at least 30 minutes after taking the tablet.

Possible side effects includeInflamed food pipe (oesophagus), sore throat and swallowing difficulties. Chest pain or worsening heartburn needs to be reported to the doctor.

Musculoskeletal pain.

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* A generic (non-branded) form of alendronate.


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Ibandronate

Available as Bonviva*

Dose Monthly 150mg tablet

Licensing details F S

Method of administrationTaken monthly, first thing in the morning as alendronate, but an hour must be left after swallowing the tablet before normal diet is resumed.

Available as Bonviva injection

Dose 3mg intravenous injection given every 3 months


Method of administrationComes in a pre-filled syringe (3mg dose in 3ml of fluid) and is given by a healthcare professional as a 15-30 second injection into a vein once every three months. The drug is given into a small needle that is placed in a vein in the arm or the back of the hand. It is likely that referral to an appropriate consultant will be needed and that this procedure will take place in a hospital setting, although some GP surgeries may also have facilities to give intravenous drugs.

Possible side effects includeIrritation to the food pipe (as alendronate). Although both forms of ibandronate can potentially cause these problems, intravenous ibandronate bypasses the digestive tract and may, therefore, be less likely to cause irritation.Other possible side effects include rash, pain in the muscles and joints, and headache. These flu-like symptoms are well recognised and tend to occur most after the first dose and become less common and less severe with time.

*A generic (non-branded) form of ibandronate is also available.


Risedronate

Available as Risedronate sodium*Dose 35mg weekly tablet or 5mg daily tabletLicensing details F M S H GIOP

Available as Actonel once a weekDose 35mg weekly tabletLicensing details F M S H

Available as ActonelDose 5mg daily tabletLicensing details F GIOP S H

Method of administrationAs alendronate

Possible side effects includeAs alendronate but digestive irritation may notbe as likely.

Available as Actonel CombiDose Weekly 35mg risedronate tablet. Sachet calcium 1,000mg and vitamin D3 (880iu) taken daily on intervening 6 days.Licensing details F S

Method of administrationThe weekly risedronate tablet is taken as alendronate. The effervescent calcium andvitamin D3 granules are dissolved in water.

8*A generic (non-branded) form of risedronate.


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Zoledronic acid

Available as Aclasta*

Dose 5mg once yearly intravenous infusion ('drip')

Licensing details F M S H GIOP

Method of administrationThe drug is given slowly over 15 minutes via a needle inserted into a vein. This is likely to take place in a hospital clinic, although some GP surgeries may also have facilities to give intravenous drugs. If zoledronic acid is prescribed and you have recently broken your hip, it is recommended that zoledronic acid is administered two or more weeks after your hip repair surgery.

It is important that you have adequate calcium and vitamin D whilst taking zoledronic acid. Many people take these nutrients in supplement form to ensure they are taking enough. Your doctor will recommend blood tests prior to the infusion to check that your kidneys are functioning correctly and may also check that your blood calcium levels are not too low. If you have recently broken your hip, your doctor may recommend treatment with vitamin D prior to your first infusion of zoledronic acid.

Make sure you drink enough fluids – at least one or two glasses – before and after the infusion to prevent dehydration.

Possible side effects includeFlu-like symptoms including a temperature, headache and general aches and pains which may be experienced in the first few days after having an infusion of zoledronic acid. Such symptoms have been found to affect between a quarter and a third of people taking the treatment. A mild pain reliever such as paracetamol may be useful, taken regularly for a few days, to reduce any symptoms. Flu-like symptoms are most commonly experienced after


Cyclical etidronateThis drug treatment was previously available as Didronel PMO. However, as it is used infrequently in clinical practice, it has been withdrawn. There are now many other effective treatments which doctors are likely to prescribe as an alternative.

If your doctor decides to continue giving you this medicine they will have to prescribe the cyclical etidronate part of the treatment (the tablet taken for 14 days) in a different form. You will need to take two 200mg tablets of etidronate (still called ‘Didronel’) for 14 days and follow this with 76 days of a calcium or a calcium/ vitamin D supplement.

PamidronateUnlike the treatments listed previously,

the first infusion and the chance of experiencing them decreases with further doses of zoledronic acid. Occasionally people on the drug can experience a longer term severe pain in the bones and muscles.

An increase in the incidence of serious cases of a fast and irregular heartbeat called atrial fibrillation was observed in one of the major zoledronic acid studies but not in a second trial. At present, the reason why this side effect might occur is not clearly understood and its significance is uncertain. There is also some conflicting evidence that other bisphosphonates may be linked with atrial fibrillation. Further research into this issue may produce more useful information.

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*A generic (non-branded) form of zoledronic acid will also become available in the near future.


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pamidronate is not licensed in the UK as a treatment for osteoporosis. This means that it has not passed the tests that demonstrate that the drug is safe and effective for the treatment of osteoporosis. It is licensed for a different bone condition called Paget’s disease as well as bone disease caused by cancer.

The brand name for this product is Aredia and it is given via an infusion ('drip').

In the past pamidronate was prescribed by hospital consultants for people who could not tolerate the bisphosphonate tablets.

As pamidronate was given directly into the vein, it was unlikely to cause the inflammation of the food pipe (oesophagus) associated with bisphosphonate tablets. With other licensed treatments now available as injections or infusions this drug is less likely to be prescribed.

The potential side effects from pamidronate are fever and flu-like symptoms for a day or two after the infusion, joint or muscle pain, headache, nausea, a rash, redness or swelling at the site of the needle used for the infusion. Like the other bisphosphonates, pamidronate has been linked, very rarely, with osteonecrosis of the jaw.


More about some rare, possible adverse effects associated with bisphosphonates

These adverse effects are explained in some detail because of the quantity of questions the Helpline has received following a number of media stories. However, it is important to remember these effects are rare and sometimes unproven.

1. Osteonecrosis of the jaw (ONJ)

There is some information suggesting a link between drugs from the bisphosphonate family and a very rare condition called osteonecrosis of the jaw (ONJ).

What is ONJ?

Osteonecrosis means that some of the cells die in the affected bone and in the jaw. This could mean delayed healing and problems if major dental work is carried out.

How common is it?

Although the drugs that may cause this are used in some patients with osteoporosis, ONJ seems to be mostly a result of using very high doses of bisphosphonate drugs, given intravenously (via a needle into a vein), in patients undergoing treatment for cancer not osteoporosis.

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Osteonecrosis, linked to bisphosphonate tablets such as alendronic acid or alendronate (Fosamax), is very unlikely to occur, affecting between 1 in 10,000 to 1 in 100,000 people per year taking the treatment for osteoporosis. Although there is very little evidence from current research studies, the risk appears to be no higher for people using the intravenous bisphosphonates for osteoporosis such as zoledronic acid (Aclasta) and ibandronate (Bonviva).

There have been only a small number of cases of ONJ (associated with bisphosphonate treatment for osteoporosis) described worldwide despite millions of users, so the risk is very low.

Could I be at risk?

The MHRA (see page 5), has stated that the majority of reported cases have been associated with dental procedures such as tooth extraction and many had signs of local infection. Other factors that may increase the risk of ONJ are having poor oral hygiene, cancer, chemotherapy or taking corticosteroid tablets. A dental examination should be considered prior to bisphosphonate treatment for these specific patients. They may also require referral to a dental hospital for advice if they require a tooth extraction or other more invasive procedures.


What should I do?

If you are taking bisphosphonates such as alendronate, risedronate, ibandronate or zoledronate for osteoporosis, the expert advice is the same as for the general population - to maintain good oral hygiene, see your dentist regularly and report any problems such as loose teeth, pain or swelling.

If you are going to start a bisphosphonate such as zoledronate for treatment of cancer to the bone, the expert advice is that you need to have a dental examination and complete any dental procedure involving exposure to bone before starting the treatment.

There is no research available yet to suggest that stopping a bisphosphonate, for those people who are already on them, will in any way reduce the risk of ONJ if they need to have dental work done.

It is obviously difficult for the many people who have been on bisphosphonates for osteoporosis for several years and who need dental procedures. They will need to have discussions with their dentist although without any of the risk factors listed above it should be possible to go ahead with dental work without any significant concerns. In fact routine care by a dental professional would be recommended. Dentists have been advised in guidance from

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their professional organisation and also from a Scottish dental advisory panel that reflects this.

2. Unusual (or ‘atypical’) thigh bone fractures

What is an ‘atypical’ thigh bone fracture?

Stress fractures of the middle or top of the femur (thigh bone) – broken bones which are relatively unusual with osteoporosis - have been reported in a small number of patients treated with alendronate tablets for osteoporosis. Most of those affected had been taking alendronate for at least three years. The fractures occurred after little or no force and in many cases there was a history of pain at the site of fracture, the thigh or groin, for a few weeks or months. In some cases the fractures affected both sides and they were often slow to heal. In most cases, the fractures healed after alendronate was discontinued.

Are these fractures caused by bisphosphonates?

At present it is uncertain whether these fractures are directly related to treatment with alendronate but an association has not been excluded. Bisphosphonates slow down the rate at which bone is destroyed and replaced, by reducing the activity of osteoclast cells that break down bone. Although this is a useful


process to prevent bone loss and fractures, there are concerns that over a prolonged period of time, this may result in bones becoming ‘older’ and more brittle. If this was the case, these drugs could become ineffective or even harmful.

What can my doctor do to reduce the risk?

Some doctors have advocated a ‘drug holiday’. This means stopping treatment for a year or two before reassessing the need for further treatment with the original or an alternative drug. The aim of this is to try and reduce the risk of these potential problems occurring although no research has proved this is useful. Others feel that stopping treatment for a period of time if you are at high risk of fracture and, particularly after previous fragility fractures, would be inadvisable. Unfortunately there is no definite answer to this question and your doctor or specialist will need to make decisions about how long to take a treatment depending on your own specific situation. However, it should be remembered that these unusual fractures are very rare and that in the vast majority of patients the benefits of treatment, in terms of preventing osteoporotic fractures, will far outweigh the risk of having these unusual fractures.

So far, most of these fractures have been reported in patients taking alendronate

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rather than other bisphosphonates such as risedronate, ibandronate and zoledronate but this may just reflect the relatively small use of these treatments in comparison to alendronate.

What can I do?

1. If you have been on bisphosphonate treatment for more than 5 years, discuss this with your doctor to make sure you need to stay on the treatment.

2. If you have unexplained pain in the middle part of your thigh whilst taking bisphosphonates it would be sensible to discuss this with your doctor.

The MHRA (see page 5), has stated that if you were unfortunate enough to have one of these rare fractures you would need to stop taking bisphosphonates unless a specialist advised otherwise. However without an unusual/atypical fracture, if you are at high risk of osteoporotic fractures, the benefits of taking these drugs will outweigh the risks and there is no reason to stop taking your treatment.


3. Oesophageal cancer

What is oesophageal cancer?

Oesophageal cancer is a relatively uncommon growth in the food pipe. The earliest symptom is often dysphagia - difficulty swallowing - although this can occur with other conditions affecting the gullet.

Do bisphosphonates increase the risk?

Two recent studies have looked at whether taking bisphosphonates by mouth increased the risk of oesophageal cancer. One study showed no increase and another study suggested an increase.

The first study looked at 42,000 patients taking bisphosphonates. The drugs were safe with no increased risk within the first 5 years of follow-up.

The second study published in the British Medical Journal (BMJ) compared 3000 patients with a diagnosis of oesophageal cancer with those without and found more patients with cancer had used bisphosphonates. Nevertheless an earlier study from Denmark showed a lower incidence of oesophageal cancer in patients taking bisphosphonates so any association is still uncertain.

The MHRA (see page 5), has stated that the BMJ

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study does not prove that bisphosphonates lead to an increased risk – it might be that people taking bisphosphonates are more likely to have investigations for a sore gullet and therefore more likely to be diagnosed or it might be some other factor that is more common in those that take bisphosphonates. More research is needed to investigate any possible link.

What should I do?

Generally the benefits of bisphosphonates will outweigh the possible but unproven risk, although it makes sense to avoid any oesophageal irritation as far as possible by carefully following instructions about taking tablets. Bisphosphonate tablets should be taken in the morning with a large glass of tap water and your upper body should remain upright for at least half an hour. However, with most bisphosphonates, it is important that you take tablets first thing in the morning on an empty stomach and wait as instructed before eating and drinking other fluids apart from water – just to make sure the tablet is absorbed.

If you are having side effects with a sore gullet etc (and particularly if you have a condition called Barrett’s oesophagus or other risk factors for oesophageal cancer) it is advisable to discuss other alternative drug treatments that are available with your doctor. In general this possible risk is not a reason to discontinue your drug treatment for osteoporosis.


Selective Estrogen Receptor Modulators (SERMs)Although not hormones, SERMs mimic the action of the hormone oestrogen on certain organs or tissues in the body while at the same time blocking the effect of oestrogen in others. At present, the only SERM used in the field of osteoporosis is raloxifene (Evista). Raloxifene mimics the positive effects of oestrogen on bone tissue helping to keep bone strong but does not affect breast or womb tissue. This means that long-term use of raloxifene does not carry the increased risk of cancer of the lining of the womb (endometrial cancer) or breast cancer that is associated with long-term use of oestrogen-based hormone replacement therapy (HRT).

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Raloxifene

Available as Evista*

Dose 60mg daily tablet


Method of administrationDaily tablet. Swallowed whole at any time, with or without food.

Possible side effects include The risk of developing a blood clot in a vein appears to be increased - a risk similar to that of hormone replacement therapy (HRT) or the contraceptive pill containing oestrogen. Leg cramps and swollen hands, feet and ankles are sometimes experienced,


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Strontium ranelate (Protelos) appears to have an impact on both the cells that build bone and those that break it down. It is unclear how this works to reduce the risk of broken bones.

Strontium ranelate (Protelos)

as are hot flushes and flu-like symptoms.

The effectiveness of raloxifene has not been studied in women with breast cancer and there has been no work performed to investigate the interaction of the treatment with drugs used to treat breast cancer and to prevent its reoccurrence. Raloxifene should not be considered until such drugs have been discontinued. Research trials have shown a reduction in breast cancer risk in women at low risk who were taking raloxifene for their bones. For women with above average risk for developing breast cancer the benefit was equivalent to tamoxifen. In theory, this may indicate that raloxifene could be a treatment option for post-menopausal women at high risk of breast cancer. This has been reflected in recent guidance from the National Institute of Health and Care Excellence (NICE). This guidance has suggested that raloxifene can be offered to women at high risk of breast cancer to reduce their risk of developing the disease and has advantages over tamoxifen (a current treatment for breast cancer) in women who have not had their womb removed (hysterectomy).

Raloxifene can increase certain fatty acids in the blood, which can increase the risk of developing heart disease (specifically serum triglycerides). If people already have known raised levels of triglycerides in the blood, they should have levels monitored if taking raloxifene.

*A generic (non-branded) form of raloxifene is also available.


Available as Protelos

Dose 2g sachet of tasteless powder to be mixed in a glass of water

Licensing details F M S H*

Method of administrationIt should be taken once daily preferably at bedtime at least two hours after eating and at least 2 hours before any food or drink, other than water. This is because the absorption of the drug may be affected if food or drink other than water is present in the stomach.

Possible side effects includeNausea and diarrhoea. Those side effects reported were mild and short-lived and generally reported at the beginning of treatment. There is a slight increase in the risk of blood clots associated with strontium ranelate. In 2012 the licence was amended and strontium ranelate is now not considered appropriate for those who have had a blood clot or are immobile or likely to be, e.g after an operation. People over the age of 80 at risk of blood clots need to have their treatment reviewed to make sure the medicine is appropriate.

A rare type of severe allergic reaction to strontium ranelate has been reported. This is a serious hypersensitivity reaction, which can also occur with a number of other drugs. It usually develops within 3-6 weeks of starting strontium ranelate, but generally resolves on drug withdrawal and steroid treatment. Although rare, anyone who develops a skin rash, fever, swollen glands or mouth ulcers whilst taking strontium ranelate is advised to stop the treatment immediately and seek advice from their doctor. They would not be advised to restart the treatment even after the symptoms have resolved.

In March 2013 following an assessment of research findings showing an increased risk of heart attacks in people taking strontium ranelate, the MHRA (see

* There may be some restrictions on its use in Scotland and Wales.

Strontium ranelate


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Parathyroid hormone (PTH) is naturally produced by the body to help in the regulation of calcium. When used as a daily subcutaneous injection (a small injection under the skin), this treatment acts as a bone forming agent which is used to strengthen bones and reduce the risk of fractures. It differs from other available treatments which work by suppressing the action of the osteoclasts which break down bone. PTH is the first treatment to renew the skeleton by stimulating the cells called osteoblasts, which form new bone.

Parathyroid hormone treatment

Parathyroid hormone treatment

Available as Teriparatide (Forsteo)

Dose 20 micrograms subcutaneous injection (under the skin) given daily for a maximum of 24 months

Licensing details F M GIOP S

page 5) made the following recommendations: The drug should not be used in people with, or who have suffered from, ischemic heart disease, peripheral arterial disease or cerebrovascular disease or in those with uncontrolled blood pressure. They also stated that people who are at risk of heart disease should only be treated with strontium ranelate after careful consideration of the risks and benefits.


Available as Preotact

Dose 100 micrograms subcutaneous injection (under the skin) given daily for a maximum of 24 months (although Preotact is given in a higher dose, this is essentially equivalent in terms of strength to teriparatide (Forsteo))


PTH treatment has been trialled in people with severe osteoporosis who have previously brokenbones, and so is most likely to be used in people with previous fractures for whom other treatments seem unsuitable. The treatment will initially be prescribed by hospital consultants with nursing support in the community because this treatmentmust be given by injection. PTH treatment ismore expensive than other treatments. Decisionsregarding who may be suitable for this treatmentmay be affected by local, national and NationalInstitute for Health and Care Excellence (NICE)guidelines.

Method of administration

Teriparatide (Forsteo) is supplied in a pre-filledsyringe pen which is similar to a diabetic injectionpen with a very fine needle. This pen will last for28 days.

Preotact is supplied in a cartridge which is theninserted into the Preotact pen that is again similar to a diabetic injection pen. Each cartridge is changed every 14 days.

PTH is given as a subcutaneous injection by theindividual on a daily basis, preferably at the same time each day. People may be prescribed one pen/ cartridge at a time or in multiple packs (this may depend on availability in some areas).

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If you are prescribed this treatment, you will need a healthcare professional such as a nurse to instruct you on how to use the injection pen. Teriparatide needs to be stored in a refrigerator when not in use and a new needle is required for each injection. If it is difficult to access a refrigerator, e.g. whilst travelling, Preotact can be stored for up to seven days outside of the fridge.

Possible side effects includeNausea, limb pain, headache, dizziness, hypotension (low blood pressure) and depression (Forsteo).

Changes in the levels of calcium in the blood and/or urine have been observed in patients commencing treatment with Preotact. It is, therefore, recommended that patients starting this treatment should have blood or urine tests after one, three and six months to monitor the level of calcium. No monitoring of calcium levels is required for teriparatide (Forsteo).

Parathyroid hormone treatment can only be used in adults and cannot be taken if:• You have had a previous allergic reaction to

parathyroid hormone

• You have high blood calcium levels known as hypercalcaemia

• You have severe kidney or liver problems

• You have another bone disease, e.g. Paget’s disease

• You have had radiation therapy to the skeleton

• You are pregnant or breast feeding (although only licensed for post-menopausal use, occasionally it may be used by specialists in the younger woman).


Denosumab belongs to a group of treatments called monoclonal human antibodies. It works by blocking a substance involved in bone development known as RANK ligand. RANK ligand stimulates the production and activity of bone cells called osteoclasts which increase bone breakdown. By blocking RANK ligand, denosumab aims to increase bone density and strength thereby reducing the risk of broken bones.

Denosumab (Prolia)

Denosumab(Prolia)

Available as Prolia

Dose 60mg subcutaneous injection (under the skin) every 6 months. Licensing details F S H MS*

Method of administration Denosumab is given as a subcutaneous injection (under the skin) every 6 months. This may occur in a hospital, clinic or GP surgery.

Possible side effects includeUrinary tract infection, chest infection, cataract, constipation, rash, sciatica and limb pain. An increase in risk of cataract was seen in those men using denosumab because of their prostate cancer treatment but not in post-menopausal women using it for osteoporosis.

* Licensed to be used in men with bone loss caused bytreatments for prostate cancer.

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Patients receiving denosumab may uncommonly develop skin infections (predominantly cellulitis). Cellulitis is a bacterial infection of the skin and the layer of fat and soft tissues that lie underneath. The infection can make the skin red, swollen and painful. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Your doctor may recommend blood tests prior to each injection to check that your blood calcium levels are not too low and your kidneys are functioning correctly. A rare adverse effect called osteonecrosis of the jaw (ONJ) has been linked with this treatment. There is no specific guidance on this rare problem in relation to denosumab but for general information on ONJ please see page 12. There have been a small number of people who have experienced atypical thigh bone fractures (see page 15) whilst taking denosumab.

Denosumab cannot be taken if you have:

• A rare hereditary intolerance of fructose (a simple sugar found in fruit and vegetables)

• A low blood calcium level (hypocalcaemia).This must be corrected by an adequate intake of calcium and vitamin D before starting on denosumab as very rarely denosumab treatment can cause blood calcium levels to drop

• A latex allergy. The needle cover of the prefilledsyringe contains dry natural rubber (a derivative of latex).


How much do we need and are supplements necessary?

A recommended daily intake of 700mg of calcium will ensure that most adults get what they need. Generally people can get sufficient calcium in their food and drink and vitamin D from normal exposure to sunlight so they do not need to take supplements.* However if you have a low calcium intake or limited exposure to sunlight then supplementation may be necessary. Those with osteoporosis, taking drug treatments, may benefit from increasing their intake of calcium to around 1000 mg daily as patients did in the clinical trials that proved osteoporosis treatments were effective.

If you are taking a calcium supplement, remember not to take it at the same time of the day as your bisphosphonate tablet, or strontium ranelate, as calcium will prevent the absorption of these drugs. Splitting the dose of calcium you are prescribed, if you need two 500 mg tablets, is sometimes recommended as the gut might not be able to absorb it as efficiently if taken all at once. In terms of 28

Why do we need calcium and vitamin D?

An adequate calcium intake is important to build and maintain strong bones. Vitamin D works in a number of ways to keep bones strong and is essential to help the body absorb calcium.

Calcium and vitamin D supplements


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whether to take your supplement with or away from meals, there are arguments in favour of either approach and no expert consensus. With the amounts of calcium provided by most supplements timing probably isn’t crucial.

(*see our booklet All about osteoporosis and leaflet Healthy living for strong bones for more information about healthy eating for strong bones and getting sufficient calcium and vitamin D.)

One research study showed that calcium and vitamin D supplements reduced the risk of hip and other fractures in frail, older people who live in care homes and are likely to be deficient in vitamin D. The benefits for other older people are less clear.

Calcium supplements and heart attack risk

Research, published in the British Medical Journal, has suggested an increased risk of heart attack in people taking high doses of a calcium supplement, possibly through a slow process of calcium being laid down in blood vessels (called calcification). The research put together the results from 11 previous studies and found an increased risk in older women (average age of 72 years) taking supplements which increased their calcium levels beyond recommended daily intakes.

Although the risk was greater in those taking calcium supplements, the incidence of heart attack was still low. Out of nearly 12,000 participants followed for three and a half years,


166 of those taking a calcium supplement had a heart attack compared to 130 of those taking a placebo (dummy pill).

A further analysis of the research data published a few months later considered the use of both calcium and vitamin D supplements and again suggested a modest increase in the risk of heart attack and stroke.

There is some uncertainty about the conclusions of these studies as other research has not found that taking calcium and vitamin D supplements increases heart attack or stroke risk. The MHRA (see page 5) has looked at the research findings and recommends that doctors still need to ensure those taking osteoporosis drug treatments are getting sufficient calcium and vitamin D. Supplements should continue to be prescribed when necessary.

Although recent research in Germany has once again suggested a link between calcium supplements and heart attack, this study was unable to prove this link was significant and more research is still needed to confirm or disprove this possible effect.

To be on the safe side, it makes sense for people to assess how much calcium they are getting as part of a well-balanced diet and only supplement if necessary to top up to recommended levels. If you have a heart condition or if you feel you may be at risk of a heart attack it may be helpful to talk to your GP who will discuss with you the risks and benefits of taking a supplement.

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CalcitoninCalcitonin is a hormone that occurs naturally in the body which, by acting on the skeleton, regulates the amount of calcium in the blood.In the past calcitonin was used as a treatment for osteoporosis. However it has now been withdrawn from use as a long term treatment. A subcutaneous injection of calcitonin (under the skin) is still licensed for short term use although in practice it is rarely prescribed.

Hormone Therapy or Hormone Replacement Therapy (HRT)Oestrogen (in women) and testosterone (in men) are sex hormones which have a protective effect on the skeleton. If the body stops producing these hormones due to surgery, illness or early menopause in the case of women, replacement is often considered to protect bone. (For more information see our factsheet Hormone therapy in men and women and osteoporosis.)

Less commonly used drug treatments


CalcitriolCalcitriol is an active form of vitamin D. Vitamin D is essential for the absorption of calcium from our food. Our usual daily source of vitamin D is obtained from the ultraviolet rays of the sun and its action on our skin (90%) producing vitamin D3, and from our diet (10%). As we get older our bodies are less efficient at making vitamin D. Calcitriol works by increasing how much calcium we can absorb from food and decreasing how much calcium we excrete, thereby producing a positive calcium balance in our bodies. Calcitriol may be more effective by providing a more active and readily available form of vitamin D.

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Available as Rocaltrol

Dose 0.25 microgram tablet twice daily


Possible side effects includeSigns of too much calcium in the blood (hypercalcaemia) including loss of appetite, nausea, vomiting, headaches, weakness or drowsiness. It is more likely to occur in the early days or weeks of therapy and patients should cease therapy and consult their doctor promptly. By stopping therapy and reducing dietary calcium intake, these effects can be reversed within seven days. Calcitriol is not suitable for people who have hypercalcaemia.

Special instructionsBlood calcium levels should be monitored at four weeks, then three months, then six months and every six months thereafter to ensure the correct dosage is given. Calcium and vitamin D supplements, multivitamin preparations or herbal remedies which contain vitamin D should not be taken with calcitriol. There is a difference between calcitriol and the type of vitamin D found in supplements. Calcitriol is an active form of vitamin D normally produced in the body by the kidneys. Vitamin D supplements contain the form of vitamin D found in sunlight and in some foods. This latter form of vitamin D has yet to be converted by the body into a usable substance.


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The National Osteoporosis Society is the only UK-wide charity dedicated to improving the prevention, diagnosis and treatment of osteoporosis and fragility fractures

To order an information pack or other publications:

0845 130 3076 or 01761 471771

[email protected]

For osteoporosis information and support contact our Helpline:

0845 450 0230 or 01761 472721

[email protected]

To become a member or make a donation:

01761 473 287

or join online at www.nos.org.uk


Last revised June 2013 NOS/00148

Other leaflets and factsheets in this range:• Anorexianervosaandosteoporosis• Anti-epilepticdrugsandosteoporosis• Breastcancertreatmentsandosteoporosis•Clothing,bodyimageandosteoporosis•Coeliacdiseaseandosteoporosis•Complementaryandalternativetherapies

and osteoporosis •Complexregionalpainsyndromeandosteoporosis• Exerciseandosteoporosis•Glucocorticoidsandosteoporosis• FurtherFoodFactsandbone-beyondcalciumand

vitamin D •Healthylivingforstrongbones•Hipprotectorsandosteoporosis• Hormonetherapyinmenandwomenandosteoporosis•Hyperparathyroiddiseaseandosteoporosis• Livingwithbrokenbones(includesinformationon

welfare benefits)•Osteoarthritisandosteoporosis•Osteogenesisimperfectaandosteoporosis•Osteoporosisinchildren• Percutaneousvertebroplastyandballoon

kyphoplasty and osteoporosis• Pregnancyandosteoporosis• Scansandtestsandosteoporosis• Thecontraceptiveinjection(DepoProvera)

and osteoporosis• Thyroiddiseaseandosteoporosis• Transsexualpeopleandosteoporosis• Vibrationtherapyandosteoporosis

President: HRH The Duchess of CornwallNational Osteoporosis Society is a registered charity no. 1102712 in England and Wales

and no. SC039755 in Scotland. Registered as a company limited by guarantee in England

and Wales no. 4995013

0845 130 3076 (General Enquiries)

0845 450 0230 (Helpline)

www.nos.org.uk

Camerton, Bath BA2 0PJ


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