Biography - Eamonn Brady MPSI is the owner of Whelehans Pharmacy in Mullingar. He graduated from the Robert Gordon University in Aberdeen in 2000 with a Masters in Pharmacy. He worked for Boots in the UK before moving back to Ireland in 2002. He bought Whelehans Pharmacy in Mullingar in 2005. He undertakes clinical training for nurses in the midlands.

CPD 21: OSTEOPOROSIS

Osteoporosis

Sponsored by Pfizer

60 Second SummaryOsteoporosis literally means "porous bones". It's a condition where bones lose density causing them to become weak and more likely to fracture. About one in two women and one in five men over 50 will fracture a bone because of osteoporosis.

Osteoporosis is usually diagnosed in hospital, often after a fall or a bone fracture. Bone density is measured using a dual-energy X-ray absorptiometry (DEXA) scanner. Osteoporosis is diagnosed when bone density is found to be significantly lower than average. DEXA scans are the gold standard for the diagnosis of osteoporosis.

There is no comprehensive osteoporosis screening programme in Ireland. People generally only get a DEXA when referred by their GP. Non-pharmacological management includes prevention of falls and modification of risk factors including: diet, smoking and excessive alcohol intake.

Learning, Evaluation, Accredited, Readers, Network | www.learninpharmacy.ie

SYMPTOMS OF OSTEOPOROSIS

Osteoporosis may have no symptoms initially, and patients may be unaware of any problems until they fracture a bone or start to lose height.

Symptoms can include:

• Sudden, severe episodes of upper, middle or lower back pain

• Loss of height (greater than 2cm)

• Development of a hump on the back or a change in body shape, for example, the rib cage may rest on pelvic rim or a pot belly develops

COMPLICATIONS OF OSTEOPOROSIS

Broken wrists, hips and spinal bones are the most common fractures in people with osteoporosis. Fractures can, however, occur in any bone. They can result in pain, disability, loss of independence and a drop in self esteem.

DIAGNOSIS OF OSTEOPOROSIS

Osteoporosis is usually diagnosed in

hospital, often after a fall or a bone fracture. Bone density is measured using a dual-energy X-ray absorptiometry (DEXA) scanner. Osteoporosis is diagnosed when bone density is found to be significantly lower than average. DEXA scans are the gold standard for the diagnosis of osteoporosis. Scans are painless and take approximately 10 to 20 minutes.

The results of the scan will be made available immediately or very soon after, depending on where it is done. Scan results will be given in the form of a T-score. A T-score value greater than -1 shows that bone density level is normal and there is no osteoporosis. A T-score value of between -1 and -2.5 indicates osteopenia. This is the early stage of osteoporosis and is a warning that a patient must start taking care of their bones. A T-score of below -2.5 meanwhile indicates osteoporosis.

There is no comprehensive osteoporosis screening programme in Ireland. People generally only get a DEXA when referred by their GP. The average waiting time to get a DEXA scan in 2008 for public patient was 20 weeks15. Private patients can get a scan

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice.

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

3. PLAN - If I have identified a knowledge gap

- will this article satisfy those needs - or will more reading be required?

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the 4 previous steps, log and record your findings.

Published by IPN and supported with an unrestricted educational grant from Pfizer Healthcare Ireland. Copies can be downloaded from www.irishpharmacytraining.ie

Disclaimer: All material published in CPD and the Pharmacy is copyright and no part of this can be used within any other publication without the permission of the publishers and author.

Osteoporosis literally means “porous bones”. It’s a condition where bones lose density causing them to become weak and more likely to fracture. About one in two women and one in five men over 50 will fracture a bone because of osteoporosis. According to the Osteoporosis Society of Ireland, it is estimated that 300,000 people in Ireland have osteoporosis. Osteoporosis can affect all age groups, but it’s most common in postmenopausal women. Having osteoporosis doesn’t automatically mean that bones will fracture; it just means that it’s more likely. In Europe osteoporosis accounts for more disability than many non-communicable diseases including rheumatoid arthritis, Parkinson’s disease and breast cancer1.

CPD 21: OSTEOPOROSIS

upon request in private facilities. The website of the Osteoporosis Society of Ireland has a comprehensive list of all locations in Ireland where DEXA scans are performed. It lists DEXA scan locations on a county by county basis and includes both private and public hospitals and clinics. Click on “Arrange a scan” on the Osteoporosis Society website to find a location closest to you.

CAUSES OF OSTEOPOROSIS

Healthy bone consists of a strong mesh made of protein and minerals (particularly calcium). This mesh is living tissue that is constantly being renewed by two types of cells. One type builds up new bone (osteoblast cells) and the other breaks down old bone (osteoclast cells). Up to our mid-20s our skeleton is strengthened, but from our 40s onwards our bones gradually lose their density as a natural part of ageing.

There is a genetic influence on osteoporosis so women with family members with the condition are more at risk. However other factors increase the risk of osteoporosis.

The breakdown of bone is quicker in women who have been through the menopause. This is because of a lack of the hormone oestrogen. Oestrogen reduces the amount of bone broken down and so helps to protect against osteoporosis. In women, oestrogen is made in the ovaries from puberty until the menopause. Anything that reduces the number of years that a woman produces oestrogen may increase the risk of osteoporosis. These include:

• an early menopause (before the age of 45)

• a hysterectomy before the age of 45 (especially if both ovaries are removed)

• excessive exercising - this can reduce hormone levels and as a result, periods may stop for a prolonged time

Other factors include:

• age - the risk increases with age

• race - Caucasian or Asian races are at greater risk than African-Caribbean

• gender - women have smaller bones than men

• a family history of osteoporosis, particularly a history of hip fracture in a parent

• a previous fragility fracture (fracturing a bone after only a minor accident)

• long-term immobility (e.g. confined to bed)

• a very low body mass index

• excessive alcohol consumption or smoking

• low levels of vitamin D or dietary calcium

Some medication and disorders can increase risk including:

• long-term use of corticosteroids

• long-term use of heparin

• aromatase inhibitors (for breast cancer treatment)

• overactive thyroid disorders

• rheumatoid arthritis

• digestive disorders that affect nutrient absorption, such as Crohn’s Disease, chronic liver disease, or coeliac disease

CAUSES IN PRE-MENOPAUSAL WOMEN

Oestrogen generally prevents osteoporosis in pre menopausal women. However there are certain medical conditions and medication which reduce oestrogen level and hence causing early onset osteoporosis.

Examples include:

• Hypogonadotropic hypogonadism due to low weight, eating disorders, excessive exercise, hyperprolactinemia, and hypopituitarism.

• Hypergonadotropic hypogonadism (premature ovarian failure) is associated with bone loss if oestrogen is not replaced. Women with Turner syndrome (condition which occurs in less than 1 in 2500 due to abnormal X chromosome) may have an additional selective reduction in bone mineral density that is independent of oestrogen exposure.

• In premenopausal women with breast cancer, chemotherapy often results in premature ovarian failure, and as a result, oestrogen deficiency and bone loss.

Drugs that may be associated with bone loss in premenopausal women include glucocorticoids, anticonvulsants (e.g.) phenytoin, antidepressants (e.g.) Lithium and anticoagulants (e.g.) warfarin and heparin.

NON PHARMACOLOGICAL MANAGEMENT

Non-pharmacological management includes prevention of falls and modification of risk factors including: diet, smoking and excessive alcohol intake. Important measures aimed at preventing falls include attention to modifiable factors including: checking eyesight, exercise, reduced consumption of medication that alters alertness and balance, and improvement of the home environment. There is controversy on the use of hip protectors to prevent fractures, with recent evidence casting doubt on this preventive measure.2, 3. Attention to diet is important, because there is a high prevalence of calcium and vitamin D insufficiency in the elderly, particularly those with chronic conditions. Calcium is necessary for maintaining bone health and vitamin D enhances the absorption of calcium. A diet with adequate calcium (>1,200mg daily) and vitamin D (800 IU daily) is recommended for those with risk factors.

Adults over 50 years often only consume 700mg calcium daily, so the use of supplements, including fortified food products, may be required.

Evidence for the use of calcium and vitamin D supplements to maintain optimum bone density in healthy adults with normal dietary intake is limited.4, 5 However a recent systematic review found that the ingestion of calcium or calcium with vitamin D reduced osteoporotic fractures in men and women over 50 years by 12%.6 They should be considered for patients in nursing/residential homes and the housebound elderly. Immobilisation is an important cause of bone loss and should be avoided whenever possible.

Sponsored by PfizerLearning, Evaluation, Accredited, Readers, Network | www.learninpharmacy.ie

Sponsored by PfizerLearning, Evaluation, Accredited, Readers, Network | www.learninpharmacy.ie

CPD 21: OSTEOPOROSIS

SELF HELP

Osteoporosis patients need to be careful of vigorous, high-impact exercise. However, leading an active lifestyle will improve balance, coordination and develop muscle strength. All these can reduce the risk of falling and fracturing a bone.

Beneficial exercise includes swimming, gardening, walking and golf. Eating a diet rich in calcium is important for maintaining healthy bones. Dairy products and green leafed vegetables are good sources of calcium. Low or non-fat versions of dairy products deliver just as much if not more than their fattier counterparts. If a patient cannot stomach dairy, calcium-fortified orange, grapefruit, and apple juice contain just as much as milk does.

The body also needs vitamin D to absorb calcium properly. Vitamin D is found in certain foods, including cod liver oil, oily fish such as sardines and herrings, margarine and egg yolks. It’s also made by the skin when exposed to sunlight. The National Osteoporosis Society recommends about 20 minutes of sun exposure to the face and arms, every day during the summer, to provide enough vitamin D for the year. Avoid fizzy drinks and reduce caffeine, salt or animal protein, as these can affect the balance of calcium in the body.

NEW RESEARCH ON VITAMIN D

New research has found that a daily supplement of 700 to 1000IU of vitamin D reduces the risk of fractures from falls among older people by 19%. In-fact the British Medical Journal shows that a dose of less than 700IU per day has no effect in reducing fractures. For example, an Ideos® or a Calcichew D3® tablet only has 400IU (500mg) of vitamin D, therefore it important that a patient takes two daily to get the sufficient amount of vitamin D.

RISK OF OSTEOPOROSIS FROM CORTICOSTEROIDS

Patients on corticosteroids require preventive treatment for osteoporosis if the patient is starting oral corticosteroids and is likely to be on these for at least 3 months. More than three or four courses of corticosteroids taken in the previous 12 months is considered to be equivalent to more than 3 months of continuous treatment. If the intermittent courses are spread over a much longer term, the risk is not as high. Evidence supports the use of bisphosphonates as a first line treatment.

PHYSIOTHERAPY FALLS PREVENTION PROGRAMME

Many physiotherapy departments in Ireland have a falls prevention programme that GPs or hospital consultants can refer patient to.

Patients with a history of falls, fear of falling and/or reduced mobility are often referred to a physiotherapy falls prevention programme. The programme is often based on the OTAGO exercise programme and aims to strengthen muscles thus preventing falls and reducing the risk of fracture if the patient does fall. Contact the physiotherapy department at your local hospital to check if this programme is available in your area.

HSE FALL PREVENTION POLICY

The following is the HSE fall prevention policy outlined in their 2008 fall prevention report.15:

All older persons should be asked the following at least once a year:

• Have you fallen during the past year? If yes, did you fall more than once?

• Have you any problems with your balance?

• Are you afraid of falling?

Older persons who have had a single explained fall should be tested for gait and balance annually.

Older persons who:

• have recurrent falls (2 or more in the last year)

• had an unexplained fall

• have problems with gait and balance or

• have a fear of falling

should undergo a multi-factorial assessment carried out by an experienced clinician.

The HSE state in their report that the following risk factors and interventions that have been shown to reduce falls and should be included in multi-factorial assessment and intervention are:

• Individualised exercise programme that includes a combination of resistance training, gait, balance, and co-ordination training

• Medication review and withdrawal of psychotropic and other medications

• Home environment assessment and modification by health professional

• Managing postural hypotension.

• Vision assessment and referral for intervention

• Assessment for Vitamin D deficiency and insufficiency and treated if identified

• Identification of foot problems and

appropriate treatment

• Behavioural modification and educational programmes should be considered

The following is a recommendation for Residential Long Stay Care settings in the 2008 HSE Fall prevention report.15

• All residential care settings should have a fall prevention policy and be resourced to implement it.

• All residents should receive a Fall Risk Assessment annually. A Fall Risk Assessment should also take place on admission and when health status changes occur.

• Falls in residential care and nursing care homes should be recorded on a register. Each fall should be critically analysed for corrective action.

The fall prevention procedures of residential care homes are assessed in all Health Information and Quality Authority (HIQA) inspections.

MEDICATION

Bisphosphonates. Examples include Alendronic Acid, Risedronic Acid and Ibandronic Acid. They work by slowing down bone loss. They are taken once weekly but Ibandronic Acid (Bonviva®) is once a month. They can reduce the frequency of fractures by 50%. Bisphosphonates have been used in trial extensions for up to 10 years, which suggest that bone quality remains normal and that reductions in fracture risk are sustained for as long as treatment continues.7 However, it is important it is reviewed every two years. There is no difference in the efficacy or safety profiles of biphosphonates in the patients aged under 65 and over 65.

The oral bioavailability of bisphosphonates is

Sponsored by PfizerLearning, Evaluation, Accredited, Readers, Network | www.learninpharmacy.ie

CPD 21: OSTEOPOROSIS

low and impaired by food. Oral formulations must be taken fasting, sitting upright with a full glass of water, followed by no food for up to 1 hour. This is to reduce the gastrointestinal effects experienced by patients. Compliance with treatment is a problem, particularly in view of these requirements. 8,9,10 The most common side effects are gastrointestinal including non-ulcer dyspepsia, oesophagitis, oesophageal strictures (narrowing of oesophagus), gastric and duodenal ulcers. Bisphosphonates are contraindicated in the presence of abnormalities of the oesophagus, and hypocalcaemia. There have been reports of osteonecrosis of the jaw (ONJ) reported with their use, particularly with IV formulations given in high doses for metastatic bone disease.11-13 ONJ is a condition where the jaw breaks. The prevalence of ONJ with biphosphonates has been estimated to be about 1 in 100,000 patient-years, which is similar to the prevalence in the overall population.13

Strontium ranelate (e.g.) Protelos® may be prescribed this if a patient can’t take bisphosphonates. This drug stimulates new bone to grow and reduces bone loss. It is taken once daily, it is a sachet put in water. Trials show it reduces vertebral fractures by 41% and hip fractures by 36%. It should be used with caution in patients at increased risk of venous thromboembolism (VTE); there have been reports of VTE, even though a causal relationship has not been established.4

Parathyroid hormone peptides (e.g.) Forsteo®. It works through the fact it is very similar to parathyroid hormone; this hormone helps to regulate calcium levels and the activity of cells involved in bone formation. It is a subcutaneous injection (into side of stomach usually), one injection is used daily. A trained nurse from Lilly will give training in the patient’s home initially for free. Trials show it reduces fractures by average of 41%. It is only used if a patient cannot tolerate other treatments. The most common adverse effects are nausea, limb pain, headache and dizziness. Contraindications include severe renal impairment, pre-existing hypercalcaemia and metabolic bone disease other than primary osteoporosis

The selective oestrogen receptor modulator (e.g.) Raloxifene (Evista®). This is a synthetic hormone that mimics the effect of oestrogen on the bones. One tablet is taken daily. It reduces risk of fractures by approx 47%.

There have been no studies to show the effect of Evista® for more than 5 years. However according to the manufacturer there is no minimum time that Evista should be used once an improvement has been shown.

Raloxifene has been associated with an increased risk of venous thrombosis similar to that for hormone therapy, and with exacerbation of hot flushes.14 An increased risk of death due to stroke has been reported with raloxifene, and it should be used with caution in women with a history of, or risk factors for, stroke. It is contraindicated in women with child-bearing potential, history of venous thromboembolism (VTE) or unexplained uterine bleeding, hepatic impairment and severe renal impairment.

Hormone replacement therapy (HRT) relieves symptoms of the menopause by restoring hormones to a premenopausal level. HRT has also been shown to reduce osteoporosis. The use of HRT for osteoporosis prevention is restricted to short-term use for younger post-menopausal women with menopausal symptoms at high risk of fracture.1

References

1 National Osteoporosis Guideline Group - Executive summary of Osteoporosis: Clinical guideline for prevention and treatment downloaded from http://www. shef.ac.uk/NOGG

2 Sawka A, Boulos P, Beattie K, Thabane L, Papaioannou A et al, Do Hip protectors decrease the risk of hip fracture in institutional and community dwelling elderly? A systematic review and meta-analysis of randomized controlled trials. Osteoporosis International 2005; 16:1461-1474

3 Kiel D, Magaziner J, Zimmerman S, Ball L, et al, Efficacy of a hip protector to prevent hip fracture in nursing home residents. JAMA 2007; 298:413-422

4 Kanis JA, Burlet N, Cooper C, Delmas PD, Position Paper: European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis International 2008; 19:399-428

5. Qaseem A et al, Pharmacologic Treatment of Low Bone Density or osteoporosis to prevent fractures: a clinical practice guideline from the American college of physicians. Ann Intern Med 2008; 149:197-213

6. Tang BMP, Eslick GD, Newson C, Smith C, Bensousson A, Use of supplementation or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet 2007; 370:657-66

7. Liberman UA, Long-term safety of bisphosphonate therapy for osteoporosis – a review of the evidence. Drugs Ageing 2006; 23: 289-298

8. Rabenda V et al, Adherence to bisphosphonate therapy and hip fracture risk in osteoporotic women. Osteoporosis Int 2008; 19: 811-818

Pfizer Healthcare Ireland are committed to supporting the continuous professional development of pharmacists in Ireland. We are delighted to be partnering with Irish Pharmacy News in order to succeed with this.

Throughout the year, Irish Pharmacy News will deliver 12 separate modules of continuous professional development, across a wide range of therapy areas. These topics are chosen to support the more common interactions with pharmacy patients, and to optimise the patient experience with retail pharmacy.

We began the 2011 programme with a section on the Gastrointestinal System. Other topics include Diabetes (Types I and II), the Cardiovascular System, Smoking Cessation, Infections, Parkinson’s Disease, Alzheimer’s Disease, Depression and others. We hope you will find value in all topics.

Pfizer’s support of this programme is the latest element in a range of activities designed to benefit retail pharmacy. Other initiatives include the Multilingual Pharmacy Tool, a tailored Medical Communications Programme, Educational Meetings and Grants, our Patient Information Pack, new pharmacy Consultation Room brochures and other patient-assist programmes including the Quit with Help programme and www.mysterypain.ie.

If you would like additional information on any of these pharmacy programmes, please contact Pfizer Healthcare Ireland on 01-4676500 and ask for the Established Products Business Unit.

EPBU/2012/066

9. Chaiamnuay S, Saag K, postmenopausal osteoporosis. What have we learned since the introduction of bispohosphonates? Rev Endocrine Metabolic Disorder 2006; 7:101-112

10 Lekkerkerker F et al, Adherence to treatment of osteoporosis: a need for study, Osteoporosis International 2007; 18:1311-1317

11 Edwards B et al, Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet oncology 2008; 9:1166-1172

12 Bisphosphonates and osteonecrosis of the jaw in Drugs Safety Newsletter, Irish Medicines Board 2006; 23: 2. Available on www.imb.ie

13 Reid IR, Cundy T, Osteonecrosis of the jaw. Skeletal Radiolog 2009; 38:5-9

14. SPC for Evista® (raloxifene) www.medicines.ie

15 HSE. Strategy to prevent falls and fractures in Ireland’s ageing population. Report of the National Steering Group on the Prevention of Falls in Older People and the Prevention and Management of Osteoporosis throughout Life. June 2008; p66, 69