strontium ranelate in patients for whom other osteoporosis medicines are unsuitable (due to contraindications or intolerance)
Osteoporosis is a metabolic bone deterioration characterised by loss of bone mass and deterioration in the bone structure itself. Osteoporosis develops because bone is reabsorbed more quickly than it is reformed.
Bone density declines from around age 40. Women have an added rapid decline in bone density in the first 5 years after menopause and thus have a higher incidence of osteoporosis than men.
Osteoporosis is a major risk factor (but not the only risk factor) for low impact, or ‘fragility’ bone fractures. These fractures are most common in the spine, but are also frequently seen in the hip and forearm. 1 in 2 women and 1 in 3 men over age 60 will suffer from an osteoporotic fracture, the incidence increasing with age.
Hip fractures are a particular problem in people over 75 as more than 20% will die within 12 months of their fracture and 15 to 25 % will require full time nursing home care following the fracture. 17.5% of all women and 6% of all men over 50 will suffer a hip fracture at some stage in their life.
Once a person has suffered from a fragility fracture they are at much greater risk of having subsequent fragility fractures – the more fractures the greater the risk.
Treatments are available which, in combination, reduce the risk of fracture in osteoporosis by up to 50%.
There are many factors which contribute to the risk of developing osteoporosis and fragility fractures including :
Bone Density (BMD) can be measured in people at risk of osteoporosis. A Medicare rebate is available for BMD testing in :
Bone density is measured by ‘bone densitometry’ which measures the density of bone at the hip and the lower spine. Other methods such as ultrasound of the heel are unreliable.
Bone densitometry should be used to assess high risk individuals, rather than as a screening test for otherwise healthy people.
Bone densitometry is usually reported as 2 ‘scores’ :
1. The ‘T Score’ which compares the bone density with that of a young healthy adult of the same gender in their 20s. A T Score of :
2. The ‘Z Score’ which compares the bone density with the mean bone density for the population of the same age and gender. A Z Score of less than –2 reflects established osteoporosis.
A useful assessment is the Absolute Fracture Risk assessment which not only takes into account the bone density but also a range of other risk and lifestyle factors. Absolute Fracture Risk is reported at the time of some bone densitometry assessments and can also be estimated by your doctor using a calculator on the WHO website at www.shef.ac.uk/FRAX/. An Absolute Fracture Risk over 10 years of more than 20% for all fractures and/or more than 3% for hip fracture suggests that specific osteoporosis treatment is indicated.
TREATMENT to maintain good bone health should include :
1. Adequate calcium (1000mg per day) and vitamin D (800 units per day) intake, either through diet and adequate direct sun light exposure (which may be difficult to safely achieve) and/or supplementation.
2. Regular weight bearing exercise (swimming and cycling do not improve bone density)
3. Avoid falls
4. Assessing and treating any underlying medical conditions or aggravating medications
5. Dietary measures - not smoking and avoiding excess caffeine and alcohol. Salt causes extra loss of calcium in the urine, and a low salt diet is helpful.
The most common available MEDICATIONS used to treat osteoporosis include:
1. Calcium and Vitamin D. Ensuring adequate daily intake can significantly reduce the risk of fractures by improving bone density and reducing falls (as vitamin D deficiency also causes muscle weakness).
2. Bisphosphonates ( which include ‘Actonel’, ‘Fosamax’,‘Didrocal’ and ‘Aclasta’ – and their ‘generics’). Calcium and vitamin D need to be taken in conjunction with bisphosphanates, and some are packaged to include these supplements.
Bisphosphonates work by reducing the reabsorption of existing bone and are usually taken as a weekly or monthly dose. Subsequent spinal and hip fractures can be reduced by up to 50% by taking Actonel or Fosamax. Didrocal has been shown to reduce spinal fractures but not hip fractures.
These medications need to be taken on an empty stomach in the morning, with a glass of water and the patient must remain upright with nothing else to eat or drink for 30 minutes. This is required to allow the medication to be absorbed and to reduce reflux. The most common side effect is gastric upset and reflux and those with severe reflux should not take oral bisphosphonates.
A rare complication is ‘osteonecrosis’ of the jaw which is a form of bone decay usually developing in the presence of dental and gum disease or following tooth extraction. Most cases have been reported in patients being treated with bisphosphonates for Pagets disease or forms of bone cancer where the medication is given intravenously at much higher dose. Any dental problems or tooth extractions should be attended to before commencing bisphosphonate treatment for osteoporosis.
There is also a suggestion that long term use may cause bones to become more ‘brittle’ and result in unusual fractures after trauma.
The NPS (National Prescriber Service) suggests having at least a 1 to 2 year break from medication after 5 years of treatment.
Bisphosphonates are subsidised by the PBS for :
‘Aclasta’ (zolendronic acid’) is a potent bisphosphonate administered once a year by IV infusion – it is available on the PBS with treatment limited to one infusion per year for 3 years during a whole lifetime. Side effects often associated with the infusion include fever, headache and muscle and joint pain, which may last up to 3 days. Atrial fibrillation can also be triggered by the infusion. Dental problems also need to be attended to prior to treatment.
3. Strontium (‘Protos’) is a newer medication which increases bone formation and reduces bone re absorption. A daily (at night) dose is required. The most common side effects are nausea, diarrhoea, headache and skin irritation. In 2013 the product information for strontium was updated following European Medicines Agency reports that it may increase the risk of serious heart problems, including myocardial infarction.
Strontium is indicated for the treatment of severe (established) osteoporosis in postmenopausal women at high risk of fracture to reduce fracture risk, and severe (established) osteoporosis in men at increased fracture risk. It should only be used in patients for whom other osteoporosis medicines are unsuitable (due to contraindications or intolerance)
Strontium is contraindicated and must not be used in patients with established, current or past history of: ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension, venous thromboembolism, pulmonary embolism. There is a very slight increased risk of developing blood clots. A very rare, but nasty side effect is an allergic skin reaction with fever, rash and inflammation of liver, kidneys and lungs, usually beginning within 3 to 6 weeks of commencing treatment.
Strontium reduces the risk of subsequent vertebral fracture by around 50% and hip fracture by 20%.
NPS recommends 3 years of treatment. It is no longer available on the PBS.
4. Raloxifene (‘Evista’) has its effect on oestrogen receptors in the body. Evista has been shown to reduce subsequent spinal fractures but not hip fractures.
Evista has the additional benefit of reducing the risk of developing breast cancer, however it may increase menopausal hot flushes and is associated with increased risk of deep vein thrombosis and stroke (to the same degree as hormone replacement therapy). It has PBS approval for postmenopausal women with established osteoporosis and a minimal trauma fracture.
Evista should be ceased during periods of immobilisation.
NPS recommends 4 years of treatment.
5. Hormone Replacement Therapy improves bone density and reduces fracture risk, however the associated increased risk of blood clots, stroke and breast cancer mean that HRT is not a recommended treatment for osteoporosis and fracture prevention.
MEASURES TO REDUCE OSTEOPOROSIS and FRACTURE RISK
1. Ensure adequate intake of calcium and vitamin D – which is difficult to achieve, especially for the elderly.
2. Have a supervised weight bearing exercise and balance program
3. Review medication taken to reduce falls risk if possible.
4. Implement other falls prevention strategies including home safety (removing loose mats and other obstacles), ensure adequate vision, have a good diet and use walking and balance aids if indicated
5. Hip protectors have been shown to greatly reduce the risk of hip fracture in high risk groups, particularly within nursing homes and the very elderly.
WHO SHOULD BE TREATED?
Normal BMD - Treatment is not recommended, however ensuring adequate calcium and vitamin D intake and regular exercise is wise.
Osteopaenia without fracture - Ensure adequate calcium and vitamin D intake and regular exercise. Recheck BMD at 2 years.
Women with osteoporosis - Treatment is indicated.
All people on long term steroids ( 7.5 mg or more for at least 3 months) - Treatment is indicated for the duration of cortisone therapy.
All men and women with fragility fractures - Drug treatment should be considered as subsequent fracture risk is high and treatment is most effective in this group.
Osteoporosis is a metabolic bone deterioration characterised by loss of bone mass and deterioration in the bone structure itself. Osteoporosis develops because bone is reabsorbed more quickly than it is reformed.
Bone density declines from around age 40. Women have an added rapid decline in bone density in the first 5 years after menopause and thus have a higher incidence of osteoporosis than men.
Osteoporosis is a major risk factor (but not the only risk factor) for low impact, or ‘fragility’ bone fractures. These fractures are most common in the spine, but are also frequently seen in the hip and forearm. 1 in 2 women and 1 in 3 men over age 60 will suffer from an osteoporotic fracture, the incidence increasing with age.
Hip fractures are a particular problem in people over 75 as more than 20% will die within 12 months of their fracture and 15 to 25 % will require full time nursing home care following the fracture. 17.5% of all women and 6% of all men over 50 will suffer a hip fracture at some stage in their life.
Once a person has suffered from a fragility fracture they are at much greater risk of having subsequent fragility fractures – the more fractures the greater the risk.
Treatments are available which, in combination, reduce the risk of fracture in osteoporosis by up to 50%.
There are many factors which contribute to the risk of developing osteoporosis and fragility fractures including :
- a family history of osteoporosis on the mothers side
- Caucasian or Asian race
- increasing age
- a previous fragility fracture
- a loss of height with thoracic kyphosis (‘dowager’s hump’)
- hormonal and metabolic factors including early menopause, low testosterone levels in men, anorexia nervosa, being very underweight (BMI less than 19), type 1 diabetes and overactive thyroid, parathyroid or adrenal gland.
- certain medication, especially more than 7.5 mg of cortisone per day for more than 3 months, hormone therapy for prostate cancer, aromatase inhibitors used in breast cancer and some epilepsy medications
- certain illnesses including malabsorption syndromes such as coeliac disease and inflammatory bowel disease such as Crohn’s disease, chronic renal failure, rheumatoid arthritis, organ transplantation and chronic liver disease.
- prolonged bed rest and immobilisation
- lifestyle and diet factors including inadequate calcium intake, vitamin D deficiency (which is very common), physical inactivity and sedentary lifestyle, smoking and excessive alcohol intake especially in men.
- increased falls risk which is aggravated by poor muscle strength and tone, poor eyesight, poor diet and the use of multiple medications especially those causing sedation.
Bone Density (BMD) can be measured in people at risk of osteoporosis. A Medicare rebate is available for BMD testing in :
- all people 70 years or older
- those who have sustained a minimal trauma fracture (any age)
- people in high risk groups including those on high dose steroids or with predisposing medical conditions previously listed.
- Monitoring those with a previous low BMD (T score less than –2.5)
Bone density is measured by ‘bone densitometry’ which measures the density of bone at the hip and the lower spine. Other methods such as ultrasound of the heel are unreliable.
Bone densitometry should be used to assess high risk individuals, rather than as a screening test for otherwise healthy people.
Bone densitometry is usually reported as 2 ‘scores’ :
1. The ‘T Score’ which compares the bone density with that of a young healthy adult of the same gender in their 20s. A T Score of :
- between +1 and –1 is ‘normal’
- between –1 and –2.5 reflects ‘osteopaenia’ – some bone loss but not severe enough for osteoporosis
- less than –2.5 which reflects established osteoporosis.
2. The ‘Z Score’ which compares the bone density with the mean bone density for the population of the same age and gender. A Z Score of less than –2 reflects established osteoporosis.
A useful assessment is the Absolute Fracture Risk assessment which not only takes into account the bone density but also a range of other risk and lifestyle factors. Absolute Fracture Risk is reported at the time of some bone densitometry assessments and can also be estimated by your doctor using a calculator on the WHO website at www.shef.ac.uk/FRAX/. An Absolute Fracture Risk over 10 years of more than 20% for all fractures and/or more than 3% for hip fracture suggests that specific osteoporosis treatment is indicated.
TREATMENT to maintain good bone health should include :
1. Adequate calcium (1000mg per day) and vitamin D (800 units per day) intake, either through diet and adequate direct sun light exposure (which may be difficult to safely achieve) and/or supplementation.
2. Regular weight bearing exercise (swimming and cycling do not improve bone density)
3. Avoid falls
4. Assessing and treating any underlying medical conditions or aggravating medications
5. Dietary measures - not smoking and avoiding excess caffeine and alcohol. Salt causes extra loss of calcium in the urine, and a low salt diet is helpful.
The most common available MEDICATIONS used to treat osteoporosis include:
1. Calcium and Vitamin D. Ensuring adequate daily intake can significantly reduce the risk of fractures by improving bone density and reducing falls (as vitamin D deficiency also causes muscle weakness).
2. Bisphosphonates ( which include ‘Actonel’, ‘Fosamax’,‘Didrocal’ and ‘Aclasta’ – and their ‘generics’). Calcium and vitamin D need to be taken in conjunction with bisphosphanates, and some are packaged to include these supplements.
Bisphosphonates work by reducing the reabsorption of existing bone and are usually taken as a weekly or monthly dose. Subsequent spinal and hip fractures can be reduced by up to 50% by taking Actonel or Fosamax. Didrocal has been shown to reduce spinal fractures but not hip fractures.
These medications need to be taken on an empty stomach in the morning, with a glass of water and the patient must remain upright with nothing else to eat or drink for 30 minutes. This is required to allow the medication to be absorbed and to reduce reflux. The most common side effect is gastric upset and reflux and those with severe reflux should not take oral bisphosphonates.
A rare complication is ‘osteonecrosis’ of the jaw which is a form of bone decay usually developing in the presence of dental and gum disease or following tooth extraction. Most cases have been reported in patients being treated with bisphosphonates for Pagets disease or forms of bone cancer where the medication is given intravenously at much higher dose. Any dental problems or tooth extractions should be attended to before commencing bisphosphonate treatment for osteoporosis.
There is also a suggestion that long term use may cause bones to become more ‘brittle’ and result in unusual fractures after trauma.
The NPS (National Prescriber Service) suggests having at least a 1 to 2 year break from medication after 5 years of treatment.
Bisphosphonates are subsidised by the PBS for :
- treatment of osteoporosis following a fragility fracture in people of any age
- treatment of osteoporosis in people 70 or older with a T score of –3 or less, even if they have not suffered a fracture.
- treatment of patients on the equivalent of 7.5 mg or more of prednisolone a day for more than 3 months who have a T score of –1.5 or less.
‘Aclasta’ (zolendronic acid’) is a potent bisphosphonate administered once a year by IV infusion – it is available on the PBS with treatment limited to one infusion per year for 3 years during a whole lifetime. Side effects often associated with the infusion include fever, headache and muscle and joint pain, which may last up to 3 days. Atrial fibrillation can also be triggered by the infusion. Dental problems also need to be attended to prior to treatment.
3. Strontium (‘Protos’) is a newer medication which increases bone formation and reduces bone re absorption. A daily (at night) dose is required. The most common side effects are nausea, diarrhoea, headache and skin irritation. In 2013 the product information for strontium was updated following European Medicines Agency reports that it may increase the risk of serious heart problems, including myocardial infarction.
Strontium is indicated for the treatment of severe (established) osteoporosis in postmenopausal women at high risk of fracture to reduce fracture risk, and severe (established) osteoporosis in men at increased fracture risk. It should only be used in patients for whom other osteoporosis medicines are unsuitable (due to contraindications or intolerance)
Strontium is contraindicated and must not be used in patients with established, current or past history of: ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension, venous thromboembolism, pulmonary embolism. There is a very slight increased risk of developing blood clots. A very rare, but nasty side effect is an allergic skin reaction with fever, rash and inflammation of liver, kidneys and lungs, usually beginning within 3 to 6 weeks of commencing treatment.
Strontium reduces the risk of subsequent vertebral fracture by around 50% and hip fracture by 20%.
NPS recommends 3 years of treatment. It is no longer available on the PBS.
4. Raloxifene (‘Evista’) has its effect on oestrogen receptors in the body. Evista has been shown to reduce subsequent spinal fractures but not hip fractures.
Evista has the additional benefit of reducing the risk of developing breast cancer, however it may increase menopausal hot flushes and is associated with increased risk of deep vein thrombosis and stroke (to the same degree as hormone replacement therapy). It has PBS approval for postmenopausal women with established osteoporosis and a minimal trauma fracture.
Evista should be ceased during periods of immobilisation.
NPS recommends 4 years of treatment.
5. Hormone Replacement Therapy improves bone density and reduces fracture risk, however the associated increased risk of blood clots, stroke and breast cancer mean that HRT is not a recommended treatment for osteoporosis and fracture prevention.
MEASURES TO REDUCE OSTEOPOROSIS and FRACTURE RISK
1. Ensure adequate intake of calcium and vitamin D – which is difficult to achieve, especially for the elderly.
- Calcium rich foods include dairy products – milk, cheese, yoghurt – and calcium fortified foods.
- Vitamin D is found in fatty fish e.g. salmon, liver, eggs and vitamin D fortified food. Most vitamin D is formed in the body by exposure to direct sunlight
- Supplements with combination calcium and vitamin D are probably the easiest way to ensure adequate intake, products include ‘Ostelin with Calcium’, ‘Caltrate + D’ and ‘Citracal + D’
- Calcium citrate (in Citracal) may be more reliably absorbed than calcium carbonate.
2. Have a supervised weight bearing exercise and balance program
3. Review medication taken to reduce falls risk if possible.
4. Implement other falls prevention strategies including home safety (removing loose mats and other obstacles), ensure adequate vision, have a good diet and use walking and balance aids if indicated
5. Hip protectors have been shown to greatly reduce the risk of hip fracture in high risk groups, particularly within nursing homes and the very elderly.
WHO SHOULD BE TREATED?
Normal BMD - Treatment is not recommended, however ensuring adequate calcium and vitamin D intake and regular exercise is wise.
Osteopaenia without fracture - Ensure adequate calcium and vitamin D intake and regular exercise. Recheck BMD at 2 years.
Women with osteoporosis - Treatment is indicated.
All people on long term steroids ( 7.5 mg or more for at least 3 months) - Treatment is indicated for the duration of cortisone therapy.
All men and women with fragility fractures - Drug treatment should be considered as subsequent fracture risk is high and treatment is most effective in this group.