Consider effectiveness and tolerability when choosing therapy
Use the decision pathway for PBS-listed treatment selection for management of confirmed osteoporosis and corticosteroid-induced osteoporosis.1-10
Assess potential adverse effects against benefits when choosing between medicines.
Bisphosphonates and denosumab are generally safe and well tolerated; however, some rare adverse effects have been reported with long-term use.
Guidelines recommend ensuring adequate calcium and vitamin D levels before starting osteoporosis medicines in order to maximise their anti-fracture efficacy.1-2,9
Minimise risk of upper gastrointestinal adverse effects in patients taking bisphosphonates
Oral bisphosphonate use is associated with increased incidence of upper gastrointestinal (GI) adverse effects (eg, oesophagitis, gastritis) compared with placebo.1-2,11 Evidence for an association between bisphosphonate use and risk of oesophageal cancer is conflicting.3,9,12-13
To minimise the risk of upper GI adverse effects, advise patients to take oral bisphosphonates in the morning prior to fooda and to remain upright for at least 30 minutes afterwards.1
a Enteric-coated risedronate can be taken with or without food.
Assess cardiovascular risks prior to starting strontium ranelate, raloxifene or calcium supplements
Cardiovascular adverse events have been associated with strontium ranelate (eg, myocardial infarction [MI] and venous thromboembolism [VTE]),14-15 raloxifene (eg, deep vein thrombosis [DVT], pulmonary embolism [PE], and stroke),16-17 and calcium supplements (eg, MI and stroke).18-19 Assess the risk of cardiovascular disease before and during therapy.9 Patients should be reviewed every 6 months.20
Due to safety concerns, the TGA issued a safety alert for strontium ranelate in 2014, restricting its use to patients unable to use other medicines for osteoporosis.20 In August 2016, strontium ranelate was delisted from the PBS.
Ensure patients maintain good dental hygiene while taking bisphosphonates
Osteonecrosis of the jaw (ONJ) is a rare complication of intravenous bisphosphonates, seen mostly in patients with bone metastatic malignancies.21-22 The risk of ONJ with oral bisphosphonates or denosumab tends to be much lower with the doses used for osteoporosis.3,9,23 Advise patients to maintain good dental hygiene and to stop bisphosphonate treatment if ONJ is confirmed.1-2
Stop bisphosphonate therapy if an atypical femoral fracture occurs
The absolute risk of atypical femoral fracture (AFF) with long-term use of bisphosphonates or denosumab is very low.24 The overall benefit in preventing hip fractures with bisphosphonates greatly outweighs the risk of AFF.3 Consider AFF if the patient develops pain in the thigh, hip or groin.9 If AFF is confirmed, stop bisphosphonate therapy and check for contralateral AFF.9
Monitor treatment response and review therapy to encourage adherence
Approximately 40% of people taking osteoporosis medicines do not meet levels of adherence needed to obtain full benefit from their treatment.25
Use BMD measurements to monitor treatment response
Guidelines recommend measuring BMD prior to starting long-term corticosteroids and at least once a year for the first few years of therapy, in patients taking prednisolone (≥ 5 mg/day) or equivalent.c,1
Review diagnosis and treatment regimen if BMD losses greater than 3%–5% per year are observed in a patient taking osteoporosis medicines.2
Evaluate medicine effectiveness and adherence, or investigate for underlying causes of osteoporosis if:
- unexpected fractures occur (usually more than one fracture event)2
- a decrease in height of more than 2–3 cm is documented since last examination2,26
- the patient experiences acute back pain, which may be a symptom of a new fracture.2
b In cases of severe osteoporosis, BMD measurements can be obtained 1 year after commencing therapy.
c DXA is only MBS-subsidised for patients taking ≥ 7.5 mg/day prednisolone or equivalent for longer than 4 months and is restricted to 1 service only in a period of 12 consecutive months.
Manage modifiable risk factors to improve bone health
Modifiable risk factors should be addressed in all postmenopausal women and older men to reduce fracture risk (see Table 1).1-3,9
Consider calcium supplementation if the recommended calcium intake cannot be achieved through diet:1-2,9,27
|Vitamin D levels||
Advise patients who are vitamin D deficient (< 50 nmol/L) to take vitamin D supplements.1
Maintain serum 25-hydroxyvitamin D (25-OH D) levels at ≥ 50 nmol/L (at end of winter or early spring) for the general population or ≥ 75 nmol/L in people diagnosed with osteoporosis.1-2,9
|Exercise ||A combination of high-intensity, weight-bearing and muscle-strengthening exercise is recommended, aiming for 4–6 times per week for 30–40 minutes per session.1-2|
|Alcohol intake ||Encourage patients to reduce alcohol consumption to moderate levels; that is, ≤ 2 standard drinks per day.1-2|
|Smoking ||Encourage and advise patients to stop smoking.1-2 Refer to smoking cessation guidelines for Australian general practice for interventions and preventive health strategies.2,28|
|Risk of falls ||Reduce the risk of falls by recommending individualised fall reduction strategies: improving vision, patient education, medicines review, exercise programs focusing on strength and balance, assistive devices, treatment of postural hypotension and reduction in environmental hazards.1-2|
|Healthy weight and BMI ||Encourage patients to maintain a healthy weight and BMI (body mass index).1-2|
GP-mediated patient resources for osteoporosis such as the Bone Health Action Plan can help encourage discussion about modifiable risk factors with patients being treated with osteoporosis medicines.
- Associate Professor Vasi Naganathan, Centre for Education and Research on Ageing, University of Sydney. Ageing and Alzheimer's Institute, Concord Hospital, Sydney, NSW.
- Dr Simon Vanlint, General Practitioner and Clinical Senior Lecturer, University of Adelaide, Adelaide, SA.
- Therapeutic Guidelines. Osteoporosis. Melbourne: Therapeutic Guidelines Limited, 2015. [Online] (accessed 14 May 2015).
- Royal Australian College of General Practitioners. Clinical guideline for the prevention and treatment of osteoporosis in postmenopausal women and older men. Melbourne: RACGP, 2010. [Online] (accessed 30 April 2015).
- Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures. A national clinical guideline. Edinburgh: SIGN, 2015.
- Pharmaceutical Benefits Scheme. Zoledronic acid. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Pharmaceutical Benefits Scheme. Alendronate. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Pharmaceutical Benefits Scheme. Risedronate. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Pharmaceutical Benefits Scheme. Denosumab. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Pharmaceutical Benefits Scheme. Raloxifene. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Australian Medicines Handbook. Drugs affecting bone: osteoporosis. Adelaide: AMH Pty Ltd, 2015. [Online] (accessed 14 May 2015).
- Pharmaceutical Benefits Scheme. Teriparatide. Canberra: PBS. [PBS Online] (accessed 15 May 2015).
- Tadrous M, et al. Comparative gastrointestinal safety of bisphosphonates in primary osteoporosis: a network meta-analysis. Osteoporos Int 2014;25:1225–35. [PubMed].
- Andrici J, et al. Meta-analysis: oral bisphosphonates and the risk of oesophageal cancer. Aliment Pharmacol Ther 2012;36:708–16. [PubMed].
- Sun K, et al. Bisphosphonate treatment and risk of esophageal cancer: a meta-analysis of observational studies. Osteoporos Int 2013;24:279–86. [PubMed].
- Bolland MJ, Grey A. A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record. BMJ Open 2014;4:e005787.
- European Medicines Agency. Strontium ranelate - PSUR assessment report. EMA, 2014. [Online] (accessed 17 June 2015).
- Adomaityte J, et al. Effect of raloxifene therapy on venous thromboembolism in postmenopausal women. A meta-analysis. Thromb Haemost 2008;99:338–42.
- Barrett-Connor E, et al. Effects of Raloxifene on Cardiovascular Events and Breast Cancer in Postmenopausal Women. N Engl J Med 2006;355:125–37.
- Bolland MJ, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010;341:c3691.
- Bolland MJ, et al. Calcium supplements and cardiovascular risk. J Bone Miner Res 2011;26:899; author reply 900–1.
- Therapeutic Goods Administration. Strontium ranelate (Protos) and risk of adverse events. Canberra: TGA, 2014. [TGA Online] (accessed 16 June 2015).
- Lee SH, et al. Use of bisphosphonates and the risk of osteonecrosis among cancer patients: a systemic review and meta-analysis of the observational studies. Support Care Cancer 2014;22:553–60
- Qi WX, et al. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol 2014;19:403–10.
- Chamizo Carmona E, et al.Systematic Literature Review of Biphosphonates and Osteonecrosis of the Jaw in Patients With Osteoporosis. Reumatol Clin 2013;9:172–7
- Shane E, et al. Atypical subtrochanteric and diaphyseal femoral fractures: second report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2014;29:1–23.
- Australian Institute of Health and Welfare. Use of antiresorptive agents for osteoporosis management. Canberra: AIHW, 2011.
- Royal Australian College of General Practitioners. Guidelines for preventive activities in general practice. Melbourne: RACGP, 2016. [Online] (accessed 1 December 2016).
- Osteoporosis Australia. Calcium fact sheet. Sydney: Osteoporosis Australia, 2015. [Online] (accessed 2 June 2015).
- Royal Australian College of General Practitioners. Supporting smoking cessation. A guide for health professionals. Melbourne: RACGP, 2012. [Online] (accessed 29 June 2015).