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Top tips in Osteoporosis

Continuing the Top Tips series, Dr Malachi McKenna offers his top tips for diagnosing and managing osteoporosis

Top Tip 1: Diagnosing osteoporosis
That 40 per cent of postmenopausal women and a substantial number of elderly men suffer fragility fractures is well publicised, but that does not necessarily ensure that adequate measures are taken to prevent these fractures.

Given the high prevalence of fracture it is axiomatic that this problem must be addressed at a primary care level – in fact the GP Unit in the former East Coast Area Health Board enabled the purchase of DXA machines in the three hospitals in the locality.

The diagnosis of osteoporosis is straightforward: either based on fragility fracture (low-trauma fracture at hip, wrist, spine, or humerus) or DXA-based.

Most clinicians are familiar with the WHO classification system for diagnosing osteoporosis based on DXA T-scores – namely, a T-score at or below minus 2.5 at spine or hip yields a diagnosis of osteoporosis.

Until the provision of a national DXA screening service, clinicians must use their judgement in selecting patients for screening.

Top Tip 2: DXA pitfalls
The biggest and most common pitfall of DXA relates to the inappropriate use of the WHO classification system. The T-score categories of normal bone density, osteopenia, and osteoporosis must be assigned only to women who are either postmenopausal or in the menopause transition, and to men over the age of 50.

These categories must not be used in premenopausal women and men under the age of 50. The T-score should not be either interpreted or even reported on the DXA printout; it is possible to suppress the WHO classification assignment from the report.

Instead, the Z-score should be interpreted. The Z-score is derived by comparing the DXA result with age-matched reference range. Just like any other laboratory measurement the normal range for DXA measurement is defined in statistical terms as the mean +/- 2 standard deviations.

A Z-score below minus 2.0 should be reported as “below the expected range for age”. The referring clinician must decide if the subject has other features that permit a diagnosis of osteoporosis.

Patients with associated co-morbidities should probably be referred for specialist opinion. The term ‘osteopenia should never be applied to this age group.

Top Tip 3: Predicting fractures
While DXA is a major predictor of fracture, it is not the sole factor. The FRAX model has been in use since 2008. This incorporates DXA and other clinical risk factors i.e. age, gender, history of fragility fracture, parental history of hip fracture, current smoking, alcohol three or more units daily, history of glucocorticoid therapy, and history of rheumatoid arthritis.

The FRAX model gives an estimate in percentage terms of the likelihood of a major osteoporotic fracture (hip, spine, wrist, or humerus) over the next 10 years. The fracture risk can be estimated using on on-line calculator, although it is now part of the printout of a DXA report for some scanners and hopefully for all scanners in time.

Currently, it is recommended by the National Osteoporosis Foundation (NOF) that a FRAX estimate of 20 per cent or more warrants medication. The estimate should only be considered as a guide.

Top Tip 4: Calcium intake
According to the NOF, the recommended intake for patients with osteoporosisis 1,200mg daily. We recently reported in a sample of nearly 6,000 persons, who attended for DXA, that only 9 per cent had a dietary calcium in excess of 1,200 mg daily.

I usually recommend that patients consume low fat fortified milk, which provides about 1600 mg/litre. If a patient is not able to augment their intake, then they should be prescribed one of the chewable tablets containing both calcium and vitamin D.

Patients are occasionally intolerant or non-compliant with chewable tables; in that event they should be prescribed a soluble form of calcium and vitamin D either as a separate prescription or as a package with one of the bisphosphonates. Caution should be applied if a patient has a known history of renal stone disease.

Top Tip 5: Vitamin D intake
Equal in importance to calcium intake is ensuring adequacy in vitamin D status. Vitamin D is derived from two sources: first and foremost is skin generation of vitamin D following direct exposure of skin to sunlight; second is oral intake.

The primacy of skin generation over oral intake in vitamin supply has been known for more than 30 years. In Ireland, skin generation is absent from October to March due to absence of ultraviolet rays in our high latitude location during these months.

Oral intake that is augmented by food fortification or supplementation is the best means to both prevent and correct vitamin D inadequacy. It is possible to quantify the vitamin D status by measuring its major metabolite (25-hydroxyvitamin D) in serum, but it is not necessary.

Unless a patient has a malabsorption syndrome like coeliac disease, then a daily oral intake of about 800 to 1,000 units for a housebound person should suffice. The difficulty is that there is not a prescription formulation of low dose vitamin D in Ireland. Fortunately, as mentioned above, most prescription formulations for calcium also contain vitamin D and one of the bisphosphonates is compounded with vitamin D.

Top Tip 6: Treating osteoporosis
Once a clinician has opted for treatment, there are many options. The most potent agents have anti-fracture efficacy against all three categories of fractures: vertebral, non-vertebral, and hip. The least potent agents only have efficacy against vertebral fractures.

The preferred option is a nitrogen-containing bisphosphonate (N-BP).These agents are potent anti-resorptive substances that bind to bone crystal and directly inhibit osteoclast action. There are three oral N-BPs: alendronate, ibandronate, risedronate.

The differences between them are small, although alendronate and risedronate have better proven anti-fracture efficacy than ibandronate. NICE 2008 guidelines in the UK recommend starting with alendronate, primarily based on a cost argument because alendronate is now available as a branded generic.

Although the active ingredient in the same in both the proprietary and branded generic forms, the tablet coating is different resulting in different rates of dissolution.

Top Tip 7: Problems with bisphosphonates
Oral N-BPs are very safe drugs. Heartburn and dyspepsia are common adverse reactions that happen with all three oral N-BPs. Intolerance of one N-BP usually indicates intolerance of the others, but is worthwhile trying another before concluding that the patient is intolerant of oral N-BPs.

If a patient is intolerant of oral N-BPs, then a parenteral N-BP should be administered - either ibandronate by IV injection every three months or zoledronate by IV infusion annually. The optimum duration of N-BP therapy is not known. Studies have been conducted with alendronate for up to 10 years and have demonstrated stable bone mineral density (BMD) in those who remain on treatment compared to a gradual decline in those who stop therapy.

In 2003, case reports of osteonecrosis of the jaw were linked to N-BP therapy.

Prospective studies have shown that this is nearly exclusively linked to use of N-BP for metastatic bone disease for which high cumulative doses are given intravenously over a short period of time. The risk for patients treated for osteo-porosis is less than 1 in 10,000. A more recent concern is the frequent number of reports of mid-shaft femur fractures. These fractures may have a prodrome of mid-thigh pain. Early radiographs or radionuclide bone scans note stress fractures on the outer aspect of the mid-shaft of the femur. Minor trauma leads to a full thickness fracture.

If a patient on long-term N-BP therapy has ongoing thigh pain, then a plain radiograph should be performed. If a stress fracture is seen, then the N-BP should be stopped and an orthopaedic opinion sought

Top Tip 8: Alternatives to bisphosphonates
There are many alternatives. Raloxifene is much less potent than N-BPs, is only protective against vertebral fractures; it is protective against breast cancer, but is not licensed for this indication. Strontium ranelate has excellent anti-fracture efficacy against vertebral, non-vertebral and hip fractures. It is generally well tolerated.

Synthetic PTH therapy is available in two different formulations (teriparatide and PTH1-84); both are self-administered subcutaneously daily for 24-months. Since reimbursement if covered by the High Technology Scheme, it must be prescribed by a specialist. PTH is effective at preventing vertebral fractures but not hip fractures.

As soon as a patient completes the course of PTH they must be started on a N-BP to maintain bone gain at the spine, otherwise BMD will return to baseline within a year.

A new class of anti-resorptive agent, called denosumab,has proven anti-efficacy against fracture and is currently being considered for license by the EU authorities.

It is a monoclonal antibody. It is given by sub-cutaneous injection every six months.

It has anti-fracture efficacy against all classes of fractures. It has certain advantages over N-BPs in that it is more potent, compliance is assured because it is given by injection, and its anti-resorptive effect ceases six months after injection unlike N-BPs. However, being a new agent, its long-term safety prolife will not be known for many years.

Top Tip 9: Hormone (Replacement) Therapy
Up until the publication of the Women’s Health Initiative in 2002, hormone therapy was recommended for prevention and treatment of osteoporosis. This study showed that combination therapy of oestrogen and cyclical progestin resulted in an increased incidence of breast cancer and failed to have benefit with respect to prevention of coronary heart disease contrary to expectations. Harm exceeded benefit.

Thereafter, the term hormone therapy (HT) has replaced the older term of hormone replacement therapy (HRT) that gives a more fitting description of the intervention.

Follow-on studies have shown that the rate of rise in breast cancer was attenuated by stopping HT.

It is now recommended that the lowest dose of HT be given for the shortest period of time for management of menopausal symptoms. During HT no bone protection is needed. A related issue is bone protection in women with curable breast cancer who are given adjuvant therapy.

In recent years, as a consequence of superior efficacy in preventing breast cancer recurrence, aromatase inhibitors (which block the peripheral conversion of androgens to oestrogens) have replaced tamoxifen.

Compared to those taking tamoxifen, patients who are taking aromatase inhibitors have a higher rate of fracture and lose bone at a faster rate. Patients should have a DXA scan and should be considered for bone protection

Top Tip 10: Steroid therapy
If a GP starts glucocorticoid therapy for a condition such a polymyalgia rheumatic and anticipates that the patient will need treatment at a dose equivalent to prednisolone 5mg daily for more than three months, then bone protection should be started contemporaneous.

It is not necessary to perform a DXA scan, but it is advisable to establish a baseline and to assess the response to intervention. N-BPs are the preferred agents for prevention of glucocorticoid-induces bone loss, although teriparatide may also be an option in certain cases.

l Malachi J. McKenna, Consultant Endocrinologist St. Michael’s Hospital & St. Vincent’s University Hospital.

l The views expressed above are those solely of the author(s)and in no way may be deemed to reflect the views or policy of either MSD Science Centre or Merck Sharp & Dohme Ireland (Human Health) Limited.

Posted in Musculoskeletal on 27 November 2009
Tags: osteoporosis

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Top tips in Osteoporosis

Continuing the Top Tips series, Dr Malachi McKenna offers his top tips for diagnosing and managing osteoporosis

Top Tip 1: Diagnosing osteoporosis
That 40 per cent of postmenopausal women and a substantial number of elderly men suffer fragility fractures is well publicised, but that does not necessarily ensure that adequate measures are taken to prevent these fractures.

Given the high prevalence of fracture it is axiomatic that this problem must be addressed at a primary care level – in fact the GP Unit in the former East Coast Area Health Board enabled the purchase of DXA machines in the three hospitals in the locality.

The diagnosis of osteoporosis is straightforward: either based on fragility fracture (low-trauma fracture at hip, wrist, spine, or humerus) or DXA-based.

Most clinicians are familiar with the WHO classification system for diagnosing osteoporosis based on DXA T-scores – namely, a T-score at or below minus 2.5 at spine or hip yields a diagnosis of osteoporosis.

Until the provision of a national DXA screening service, clinicians must use their judgement in selecting patients for screening.

Top Tip 2: DXA pitfalls
The biggest and most common pitfall of DXA relates to the inappropriate use of the WHO classification system. The T-score categories of normal bone density, osteopenia, and osteoporosis must be assigned only to women who are either postmenopausal or in the menopause transition, and to men over the age of 50.

These categories must not be used in premenopausal women and men under the age of 50. The T-score should not be either interpreted or even reported on the DXA printout; it is possible to suppress the WHO classification assignment from the report.

Instead, the Z-score should be interpreted. The Z-score is derived by comparing the DXA result with age-matched reference range. Just like any other laboratory measurement the normal range for DXA measurement is defined in statistical terms as the mean +/- 2 standard deviations.

A Z-score below minus 2.0 should be reported as “below the expected range for age”. The referring clinician must decide if the subject has other features that permit a diagnosis of osteoporosis.

Patients with associated co-morbidities should probably be referred for specialist opinion. The term ‘osteopenia should never be applied to this age group.

Top Tip 3: Predicting fractures
While DXA is a major predictor of fracture, it is not the sole factor. The FRAX model has been in use since 2008. This incorporates DXA and other clinical risk factors i.e. age, gender, history of fragility fracture, parental history of hip fracture, current smoking, alcohol three or more units daily, history of glucocorticoid therapy, and history of rheumatoid arthritis.

The FRAX model gives an estimate in percentage terms of the likelihood of a major osteoporotic fracture (hip, spine, wrist, or humerus) over the next 10 years. The fracture risk can be estimated using on on-line calculator, although it is now part of the printout of a DXA report for some scanners and hopefully for all scanners in time.

Currently, it is recommended by the National Osteoporosis Foundation (NOF) that a FRAX estimate of 20 per cent or more warrants medication. The estimate should only be considered as a guide.

Top Tip 4: Calcium intake
According to the NOF, the recommended intake for patients with osteoporosisis 1,200mg daily. We recently reported in a sample of nearly 6,000 persons, who attended for DXA, that only 9 per cent had a dietary calcium in excess of 1,200 mg daily.

I usually recommend that patients consume low fat fortified milk, which provides about 1600 mg/litre. If a patient is not able to augment their intake, then they should be prescribed one of the chewable tablets containing both calcium and vitamin D.

Patients are occasionally intolerant or non-compliant with chewable tables; in that event they should be prescribed a soluble form of calcium and vitamin D either as a separate prescription or as a package with one of the bisphosphonates. Caution should be applied if a patient has a known history of renal stone disease.

Top Tip 5: Vitamin D intake
Equal in importance to calcium intake is ensuring adequacy in vitamin D status. Vitamin D is derived from two sources: first and foremost is skin generation of vitamin D following direct exposure of skin to sunlight; second is oral intake.

The primacy of skin generation over oral intake in vitamin supply has been known for more than 30 years. In Ireland, skin generation is absent from October to March due to absence of ultraviolet rays in our high latitude location during these months.

Oral intake that is augmented by food fortification or supplementation is the best means to both prevent and correct vitamin D inadequacy. It is possible to quantify the vitamin D status by measuring its major metabolite (25-hydroxyvitamin D) in serum, but it is not necessary.

Unless a patient has a malabsorption syndrome like coeliac disease, then a daily oral intake of about 800 to 1,000 units for a housebound person should suffice. The difficulty is that there is not a prescription formulation of low dose vitamin D in Ireland. Fortunately, as mentioned above, most prescription formulations for calcium also contain vitamin D and one of the bisphosphonates is compounded with vitamin D.

Top Tip 6: Treating osteoporosis
Once a clinician has opted for treatment, there are many options. The most potent agents have anti-fracture efficacy against all three categories of fractures: vertebral, non-vertebral, and hip. The least potent agents only have efficacy against vertebral fractures.

The preferred option is a nitrogen-containing bisphosphonate (N-BP).These agents are potent anti-resorptive substances that bind to bone crystal and directly inhibit osteoclast action. There are three oral N-BPs: alendronate, ibandronate, risedronate.

The differences between them are small, although alendronate and risedronate have better proven anti-fracture efficacy than ibandronate. NICE 2008 guidelines in the UK recommend starting with alendronate, primarily based on a cost argument because alendronate is now available as a branded generic.

Although the active ingredient in the same in both the proprietary and branded generic forms, the tablet coating is different resulting in different rates of dissolution.

Top Tip 7: Problems with bisphosphonates
Oral N-BPs are very safe drugs. Heartburn and dyspepsia are common adverse reactions that happen with all three oral N-BPs. Intolerance of one N-BP usually indicates intolerance of the others, but is worthwhile trying another before concluding that the patient is intolerant of oral N-BPs.

If a patient is intolerant of oral N-BPs, then a parenteral N-BP should be administered - either ibandronate by IV injection every three months or zoledronate by IV infusion annually. The optimum duration of N-BP therapy is not known. Studies have been conducted with alendronate for up to 10 years and have demonstrated stable bone mineral density (BMD) in those who remain on treatment compared to a gradual decline in those who stop therapy.

In 2003, case reports of osteonecrosis of the jaw were linked to N-BP therapy.

Prospective studies have shown that this is nearly exclusively linked to use of N-BP for metastatic bone disease for which high cumulative doses are given intravenously over a short period of time. The risk for patients treated for osteo-porosis is less than 1 in 10,000. A more recent concern is the frequent number of reports of mid-shaft femur fractures. These fractures may have a prodrome of mid-thigh pain. Early radiographs or radionuclide bone scans note stress fractures on the outer aspect of the mid-shaft of the femur. Minor trauma leads to a full thickness fracture.

If a patient on long-term N-BP therapy has ongoing thigh pain, then a plain radiograph should be performed. If a stress fracture is seen, then the N-BP should be stopped and an orthopaedic opinion sought

Top Tip 8: Alternatives to bisphosphonates
There are many alternatives. Raloxifene is much less potent than N-BPs, is only protective against vertebral fractures; it is protective against breast cancer, but is not licensed for this indication. Strontium ranelate has excellent anti-fracture efficacy against vertebral, non-vertebral and hip fractures. It is generally well tolerated.

Synthetic PTH therapy is available in two different formulations (teriparatide and PTH1-84); both are self-administered subcutaneously daily for 24-months. Since reimbursement if covered by the High Technology Scheme, it must be prescribed by a specialist. PTH is effective at preventing vertebral fractures but not hip fractures.

As soon as a patient completes the course of PTH they must be started on a N-BP to maintain bone gain at the spine, otherwise BMD will return to baseline within a year.

A new class of anti-resorptive agent, called denosumab,has proven anti-efficacy against fracture and is currently being considered for license by the EU authorities.

It is a monoclonal antibody. It is given by sub-cutaneous injection every six months.

It has anti-fracture efficacy against all classes of fractures. It has certain advantages over N-BPs in that it is more potent, compliance is assured because it is given by injection, and its anti-resorptive effect ceases six months after injection unlike N-BPs. However, being a new agent, its long-term safety prolife will not be known for many years.

Top Tip 9: Hormone (Replacement) Therapy
Up until the publication of the Women’s Health Initiative in 2002, hormone therapy was recommended for prevention and treatment of osteoporosis. This study showed that combination therapy of oestrogen and cyclical progestin resulted in an increased incidence of breast cancer and failed to have benefit with respect to prevention of coronary heart disease contrary to expectations. Harm exceeded benefit.

Thereafter, the term hormone therapy (HT) has replaced the older term of hormone replacement therapy (HRT) that gives a more fitting description of the intervention.

Follow-on studies have shown that the rate of rise in breast cancer was attenuated by stopping HT.

It is now recommended that the lowest dose of HT be given for the shortest period of time for management of menopausal symptoms. During HT no bone protection is needed. A related issue is bone protection in women with curable breast cancer who are given adjuvant therapy.

In recent years, as a consequence of superior efficacy in preventing breast cancer recurrence, aromatase inhibitors (which block the peripheral conversion of androgens to oestrogens) have replaced tamoxifen.

Compared to those taking tamoxifen, patients who are taking aromatase inhibitors have a higher rate of fracture and lose bone at a faster rate. Patients should have a DXA scan and should be considered for bone protection

Top Tip 10: Steroid therapy
If a GP starts glucocorticoid therapy for a condition such a polymyalgia rheumatic and anticipates that the patient will need treatment at a dose equivalent to prednisolone 5mg daily for more than three months, then bone protection should be started contemporaneous.

It is not necessary to perform a DXA scan, but it is advisable to establish a baseline and to assess the response to intervention. N-BPs are the preferred agents for prevention of glucocorticoid-induces bone loss, although teriparatide may also be an option in certain cases.

l Malachi J. McKenna, Consultant Endocrinologist St. Michael’s Hospital & St. Vincent’s University Hospital.

l The views expressed above are those solely of the author(s)and in no way may be deemed to reflect the views or policy of either MSD Science Centre or Merck Sharp & Dohme Ireland (Human Health) Limited.

Posted in Musculoskeletal on 27 November 2009
Tags: osteoporosis