2. Several simple dietary and lifestyle interventions can help maintain BMD and/or reduce the
risk of falls and fractures, even for patients with normal bone mass.
Test bone mineral density
Test bone mineral density (BMD) with dual-energy x-ray absorptiometry (DXA,DEXA) in
the following groups:2, 4
• women ≥ 65 and men ≥ 70
• younger peri- and post-menopausal women and men with risk factors such as low body
weight (BMI < 21 kg/m2
) or prior low-trauma fracture
• anyone with other risk factors for low bone mass such as rheumatoid arthritis or systemic
steroid use for ≥ 3 months
• anyone with prior fracture after age 50
• postmenopausal women discontinuing estrogen
2 3
Make a few simple assessments
BMD measurements are reported as T-scores. Use the lowest (most negative) of the hip,
femoral neck, and lumbar spine scores for diagnosis.4
A patient who has had a low/no trauma
fracture should be considered to have osteoporosis regardless of BMD.5
T-score
≤ -2.5
Between -1.0 and -2.5
≥ -1.0
Osteoporosis
Osteopenia (“low bone mass”)
Normal bone mineral density
Diagnosis
Table 1.T-scores and diagnosis
Estimate fracture risk
A WHO fracture risk algorithm (FRAX) can be used to calculate the 10-year risk of hip and
other major osteoporotic fractures.2
The US-adapted algorithm is available at http://www.
shef.ac.uk/FRAX/ for Hispanic, Black, Caucasian, and Asian men and women. The score is
based upon age, gender, weight, height, BMD, and clinical risk factors including prior
fracture, family history of hip fracture, use of oral glucocorticoids (at a daily dose ≥ 5 mg of
prednisone or equivalent for ≥ 3 months), smoking, excessive alcohol use (3 or more drinks
per day), and rheumatoid arthritis. The risk calculator can help determine whether or not to
start drug therapy (see Figure 1). Hardcopy charts of fracture risk are available at the above
website and examples of these charts are provided as an appendix to the accompanying
evidence document.
Test
Vitamin D
Calcium
Other
• Vitamin D deficiency is common.2, 6, 7
Consider checking serum 25-OH vitamin D,
especially in older patients and those with low bone density.4
• Measure serum calcium, and work up if abnormal; a 24-hour urine calcium
≤ 50 mg suggests either insufficient calcium intake or poor absorption.4
• If a specific cause of osteoporosis is suspected, other relevant studies may
include thyroid function tests, testosterone levels in men, antibody testing for
celiac disease, and a serum parathyroid hormone level.
Comments
Table 2. A few lab tests
A few easy interventions for all patients
Intervention
Calcium
Vitamin D
Exercise*
Smoking* and
alcohol control
Falls prevention*
• Daily intake of at least 1,200 mg of elemental calcium per day for people 50 years
and older, including supplements if dietary intake is inadequate.2
• An easy-to-use dietary calcium calculator is available at http://www.myoptum
health.com/portal/ManageMyHealth/Calcium+Calculator
• For optimal absorption, a single dose of calcium supplement should contain no
more than 500 mg of elemental calcium, so divided doses may be needed.1,4
• Calcium carbonate should be taken with meals. Calcium citrate is more
expensive, but does not need to be taken with meals; it is preferred in patients
on acid-suppressive therapies.1,4
• Daily intake of 800 - 1,000 international units (IU) per day for people ≥ 50.2
• Some older patients may need at least 2,000 IU per day to maintain adequate
25(OH)D levels.2
• One strategy for correcting vitamin D deficiency is 50,000 IU weekly of oral
vitamin D2 for 8 weeks, followed by a maintenance dosage of 50,000 IU every
2-4 weeks or 1,000 IU of oral vitamin D3 once daily.1
• Re-test serum 25(OH)D levels after at least 12 weeks of supplementation,
because steady state of 25(OH)D is not achieved until that time.4
• Weight-bearing and muscle-strengthening exercises reduce the risk of falls and
increase bone density.8
• Review prescriptions that may cause impaired balance/mobility, sedation, or
confusion; check and correct vision and hearing problems; improve home safety.
• Smoking and excessive alcohol consumption (over 3 drinks per day) increase
the risk of osteoporosis.10
Yet another reason to quit smoking.
Recommendations and comments
Table 3. Interventions for all patients
*Comprehensive discussions on exercise for elderly people, falls prevention, and smoking cessation, can be found in previous iDiS modules: (i) Preventing Falls and
Enhancing Mobility, and (ii) Chronic Obstructive Pulmonary Disease, available at www.RxFacts.org.
3. Several simple dietary and lifestyle interventions can help maintain BMD and/or reduce the
risk of falls and fractures, even for patients with normal bone mass.
Test bone mineral density
Test bone mineral density (BMD) with dual-energy x-ray absorptiometry (DXA,DEXA) in
the following groups:2, 4
• women ≥ 65 and men ≥ 70
• younger peri- and post-menopausal women and men with risk factors such as low body
weight (BMI < 21 kg/m2
) or prior low-trauma fracture
• anyone with other risk factors for low bone mass such as rheumatoid arthritis or systemic
steroid use for ≥ 3 months
• anyone with prior fracture after age 50
• postmenopausal women discontinuing estrogen
2 3
Make a few simple assessments
BMD measurements are reported as T-scores. Use the lowest (most negative) of the hip,
femoral neck, and lumbar spine scores for diagnosis.4
A patient who has had a low/no trauma
fracture should be considered to have osteoporosis regardless of BMD.5
T-score
≤ -2.5
Between -1.0 and -2.5
≥ -1.0
Osteoporosis
Osteopenia (“low bone mass”)
Normal bone mineral density
Diagnosis
Table 1.T-scores and diagnosis
Estimate fracture risk
A WHO fracture risk algorithm (FRAX) can be used to calculate the 10-year risk of hip and
other major osteoporotic fractures.2
The US-adapted algorithm is available at http://www.
shef.ac.uk/FRAX/ for Hispanic, Black, Caucasian, and Asian men and women. The score is
based upon age, gender, weight, height, BMD, and clinical risk factors including prior
fracture, family history of hip fracture, use of oral glucocorticoids (at a daily dose ≥ 5 mg of
prednisone or equivalent for ≥ 3 months), smoking, excessive alcohol use (3 or more drinks
per day), and rheumatoid arthritis. The risk calculator can help determine whether or not to
start drug therapy (see Figure 1). Hardcopy charts of fracture risk are available at the above
website and examples of these charts are provided as an appendix to the accompanying
evidence document.
Test
Vitamin D
Calcium
Other
• Vitamin D deficiency is common.2, 6, 7
Consider checking serum 25-OH vitamin D,
especially in older patients and those with low bone density.4
• Measure serum calcium, and work up if abnormal; a 24-hour urine calcium
≤ 50 mg suggests either insufficient calcium intake or poor absorption.4
• If a specific cause of osteoporosis is suspected, other relevant studies may
include thyroid function tests, testosterone levels in men, antibody testing for
celiac disease, and a serum parathyroid hormone level.
Comments
Table 2. A few lab tests
A few easy interventions for all patients
Intervention
Calcium
Vitamin D
Exercise*
Smoking* and
alcohol control
Falls prevention*
• Daily intake of at least 1,200 mg of elemental calcium per day for people 50 years
and older, including supplements if dietary intake is inadequate.2
• An easy-to-use dietary calcium calculator is available at http://www.myoptum
health.com/portal/ManageMyHealth/Calcium+Calculator
• For optimal absorption, a single dose of calcium supplement should contain no
more than 500 mg of elemental calcium, so divided doses may be needed.1,4
• Calcium carbonate should be taken with meals. Calcium citrate is more
expensive, but does not need to be taken with meals; it is preferred in patients
on acid-suppressive therapies.1,4
• Daily intake of 800 - 1,000 international units (IU) per day for people ≥ 50.2
• Some older patients may need at least 2,000 IU per day to maintain adequate
25(OH)D levels.2
• One strategy for correcting vitamin D deficiency is 50,000 IU weekly of oral
vitamin D2 for 8 weeks, followed by a maintenance dosage of 50,000 IU every
2-4 weeks or 1,000 IU of oral vitamin D3 once daily.1
• Re-test serum 25(OH)D levels after at least 12 weeks of supplementation,
because steady state of 25(OH)D is not achieved until that time.4
• Weight-bearing and muscle-strengthening exercises reduce the risk of falls and
increase bone density.8
• Review prescriptions that may cause impaired balance/mobility, sedation, or
confusion; check and correct vision and hearing problems; improve home safety.
• Smoking and excessive alcohol consumption (over 3 drinks per day) increase
the risk of osteoporosis.10
Yet another reason to quit smoking.
Recommendations and comments
Table 3. Interventions for all patients
*Comprehensive discussions on exercise for elderly people, falls prevention, and smoking cessation, can be found in previous iDiS modules: (i) Preventing Falls and
Enhancing Mobility, and (ii) Chronic Obstructive Pulmonary Disease, available at www.RxFacts.org.
4. 4 5
Comparative effectiveness
No head-to-head clinical trials have studied bisphosphonates in relation to each other
or to other drug classes for anti-fracture efficacy,4
making comparisons difficult.11, 12
A large
observational study, controlling for patient characteristics, found that patient taking
bisphosphonates had lower fracture risks than those taking raloxifene or calcitonin.13
The
most affordable and tolerable bisphosphonate should be the first-line treatment for fracture
prevention.
When a prescription is needed
Bisphosphonates include alendronate (generics, Fosamax, Fosamax plus D), ibandronate
(Boniva), risedronate (Actonel, Actonel with calcium), and zoledronate (Reclast).
Consider an osteoporosis drug for postmenopausal women and men
≥ 50 who have:
• an osteoporotic hip or vertebral fracture; or
• aT-score equal to or more negative than -2.5 at any site ; or
• low BMD (T-score between -1.0 and -2.5) as well as:
– a 10-year risk of a hip fracture ≥ 3%, based on FRAX, or
– a 10-year risk of any major osteoporosis-related fracture (spine, hip,
shoulder, or wrist) ≥ 20%, based on FRAX
Postmenopausal women
• a bisphosphonate
• 2nd line therapies:
raloxifene, teriparatide,
calcitonin, denosumab
Figure 1. Algorithm for use of osteoporosis medications2, 4
Steroid-induced
osteoporosis
• a bisphosphonate
• 2nd line therapy:
teriparatide
Men
• a bisphosphonate
• 2nd line therapy:
teriparatide
Medication
Bisphosphonates
(alendronate, ibandronate,
risedronate, zoledronate)
Teriparatide (Forteo)
Raloxifene (Evista)
Denosumab (Prolia)
Estrogen-based
Hormone therapy (HT)
Calcitonin (generics,
Miacalcin, Fortical)
• Reduce the risk of vertebral, non-vertebral, and hip fractures in postmenopausal
women. Treatment beyond 5 years may not provide additional benefit in many
women.
• Also reduce the risk of vertebral fractures in men, as well as steroid-induced
osteoporosis.
• Reduces the risk of vertebral and non-vertebral fractures in postmenopausal
women with a prior vertebral fracture.
• Duration of therapy (up to 2 years only) and high cost may limit its usefulness.
• Also reduces the risk of vertebral fractures in men, as well as steroid-induced
osteoporosis.
• Reduces the risk of vertebral fractures in postmenopausal women with
osteoporosis..
• Reduces the risk of vertebral fractures in postmenopausal women with
osteoporosis.
• Reduces the risk of risk of vertebral, non-vertebral, and hip fractures in
postmenopausal women with osteoporosis.
• Although HT (estrogens with or without progestogens) is FDA-approved for the
prevention of osteoporosis in postmenopausal women, if this is the sole aim of
treatment, other drugs should be used because of the cancer and cardiovascular
side effects of HT.2
• Long term HT use is not indicated for the treatment of osteoporosis,10
and its
BMD benefits are lost soon after discontinuation.4
Efficacy
Table 4.The evidence for efficacy
5. 4 5
Comparative effectiveness
No head-to-head clinical trials have studied bisphosphonates in relation to each other
or to other drug classes for anti-fracture efficacy,4
making comparisons difficult.11, 12
A large
observational study, controlling for patient characteristics, found that patient taking
bisphosphonates had lower fracture risks than those taking raloxifene or calcitonin.13
The
most affordable and tolerable bisphosphonate should be the first-line treatment for fracture
prevention.
When a prescription is needed
Bisphosphonates include alendronate (generics, Fosamax, Fosamax plus D), ibandronate
(Boniva), risedronate (Actonel, Actonel with calcium), and zoledronate (Reclast).
Consider an osteoporosis drug for postmenopausal women and men
≥ 50 who have:
• an osteoporotic hip or vertebral fracture; or
• aT-score equal to or more negative than -2.5 at any site ; or
• low BMD (T-score between -1.0 and -2.5) as well as:
– a 10-year risk of a hip fracture ≥ 3%, based on FRAX, or
– a 10-year risk of any major osteoporosis-related fracture (spine, hip,
shoulder, or wrist) ≥ 20%, based on FRAX
Postmenopausal women
• a bisphosphonate
• 2nd line therapies:
raloxifene, teriparatide,
calcitonin, denosumab
Figure 1. Algorithm for use of osteoporosis medications2, 4
Steroid-induced
osteoporosis
• a bisphosphonate
• 2nd line therapy:
teriparatide
Men
• a bisphosphonate
• 2nd line therapy:
teriparatide
Medication
Bisphosphonates
(alendronate, ibandronate,
risedronate, zoledronate)
Teriparatide (Forteo)
Raloxifene (Evista)
Denosumab (Prolia)
Estrogen-based
Hormone therapy (HT)
Calcitonin (generics,
Miacalcin, Fortical)
• Reduce the risk of vertebral, non-vertebral, and hip fractures in postmenopausal
women. Treatment beyond 5 years may not provide additional benefit in many
women.
• Also reduce the risk of vertebral fractures in men, as well as steroid-induced
osteoporosis.
• Reduces the risk of vertebral and non-vertebral fractures in postmenopausal
women with a prior vertebral fracture.
• Duration of therapy (up to 2 years only) and high cost may limit its usefulness.
• Also reduces the risk of vertebral fractures in men, as well as steroid-induced
osteoporosis.
• Reduces the risk of vertebral fractures in postmenopausal women with
osteoporosis..
• Reduces the risk of vertebral fractures in postmenopausal women with
osteoporosis.
• Reduces the risk of risk of vertebral, non-vertebral, and hip fractures in
postmenopausal women with osteoporosis.
• Although HT (estrogens with or without progestogens) is FDA-approved for the
prevention of osteoporosis in postmenopausal women, if this is the sole aim of
treatment, other drugs should be used because of the cancer and cardiovascular
side effects of HT.2
• Long term HT use is not indicated for the treatment of osteoporosis,10
and its
BMD benefits are lost soon after discontinuation.4
Efficacy
Table 4.The evidence for efficacy
6. ONJ is a condition of localized “bone death” that has been reported rarely in patients taking
oral bisphosphonates, and can be difficult to treat. After widely publicized reports of ONJ, many
patients stopped taking their bisphosphonates, and many physicians became concerned about
whether to continue prescribing them. However, the risk of bisphosphonate-related ONJ is very
low with oral bisphosphonates used to treat osteoporosis; dental surgery increases the risk. The
condition is more commonly seen in cancer patients given intravenous bisphosphonates.16
Consider discontinuing an oral bisphosphonate for at least 3 months prior to oral surgery in
patients who have taken the drug for >3 years, or in those who have taken it for <3 years and are
on corticosteroids. The drug should not be restarted until bone has fully healed.16
76
When should I worry about osteonecrosis of the jaw (ONJ)?
Figure 2. Cost of medications used for osteoporosis
$0 $200 $400 $600 $800 $1,000
Costs of 30-day supply of defined daily dose
Alendronate 10mg oral
Ibandronate (Boniva) 5mg oral
Risedronate (Actonel) 5mg oral
Zoledronate (Reclast) 5mg IV
Raloxifene (Evista) 60mg oral
Teriparatide (Forteo) 20 micrograms SC
Calcitonin
Denosumab (Prolia), 60mg SC
Fosamax, $95
generics, $71
$111
$119
$93
$123
$948
Miacalcin 100 units SC/IM, $477
Fortical 200 units, nasal $75
Miacalcin 200 units nasal, $131
generics 200 units nasal, $110
$135
SC/IM: subcutaneous/intramuscular injection; SC: subcutaneous injection; IV: intravenous. Prices from www.epocrates.com, May 2010.
• Assess adverse effects and compliance (which is often poor).
• Encourage adequate calcium and vitamin D intake, exercise, falls prevention, smoking
cessation, and avoidance of excessive alcohol use.
• Re-check bone mineral density 2 years after starting a drug, and every 2 years thereafter.
More frequent testing may be warranted for some patients, such as those taking high-dose
steroids.
• Reassess the need for continuing use of a bisphosphonate after 5 years unless the T-score
remains lower than – 2.5.
Adherence to regimens of medications for osteoporosis (including calcium and vitamin D)
is often quite low.5, 11, 14
One study found that women with high prescription drug compliance
had a 16% lower fracture rate than those with low compliance.15
Strategies to improve adherence include:5, 11
• educate patients about the importance of the medication and the need to take it
consistently;
• consider a weekly-dosed oral bisphosphonate – it may improve adherence compared with
daily dosing in some patients;
• choose the most affordable and effective option;
• provide written instructions on dosing and duration of therapy;
• encourage a reminder system or use of an adherence aid such as a pill box; and
• ask about adverse effects (such as gastrointestinal side effects with bisphosphonates, or
hot flashes with raloxifene) and consider an alternative if indicated.
Monitor response to therapy
Cost may be a barrier to adherence. Generic alendronate is now available, making
bisphosphonate therapy more affordable. Injectable drugs may incur an additional up-front
expense.5
The costs of a 30-day supply of typical doses of these medications are listed below. The
price of calcium and vitamin D varies, but these medications are widely available and inexpensive
(under $10 per month).5
Cost
7. ONJ is a condition of localized “bone death” that has been reported rarely in patients taking
oral bisphosphonates, and can be difficult to treat. After widely publicized reports of ONJ, many
patients stopped taking their bisphosphonates, and many physicians became concerned about
whether to continue prescribing them. However, the risk of bisphosphonate-related ONJ is very
low with oral bisphosphonates used to treat osteoporosis; dental surgery increases the risk. The
condition is more commonly seen in cancer patients given intravenous bisphosphonates.16
Consider discontinuing an oral bisphosphonate for at least 3 months prior to oral surgery in
patients who have taken the drug for >3 years, or in those who have taken it for <3 years and are
on corticosteroids. The drug should not be restarted until bone has fully healed.16
76
When should I worry about osteonecrosis of the jaw (ONJ)?
Figure 2. Cost of medications used for osteoporosis
$0 $200 $400 $600 $800 $1,000
Costs of 30-day supply of defined daily dose
Alendronate 10mg oral
Ibandronate (Boniva) 5mg oral
Risedronate (Actonel) 5mg oral
Zoledronate (Reclast) 5mg IV
Raloxifene (Evista) 60mg oral
Teriparatide (Forteo) 20 micrograms SC
Calcitonin
Denosumab (Prolia), 60mg SC
Fosamax, $95
generics, $71
$111
$119
$93
$123
$948
Miacalcin 100 units SC/IM, $477
Fortical 200 units, nasal $75
Miacalcin 200 units nasal, $131
generics 200 units nasal, $110
$135
SC/IM: subcutaneous/intramuscular injection; SC: subcutaneous injection; IV: intravenous. Prices from www.epocrates.com, May 2010.
• Assess adverse effects and compliance (which is often poor).
• Encourage adequate calcium and vitamin D intake, exercise, falls prevention, smoking
cessation, and avoidance of excessive alcohol use.
• Re-check bone mineral density 2 years after starting a drug, and every 2 years thereafter.
More frequent testing may be warranted for some patients, such as those taking high-dose
steroids.
• Reassess the need for continuing use of a bisphosphonate after 5 years unless the T-score
remains lower than – 2.5.
Adherence to regimens of medications for osteoporosis (including calcium and vitamin D)
is often quite low.5, 11, 14
One study found that women with high prescription drug compliance
had a 16% lower fracture rate than those with low compliance.15
Strategies to improve adherence include:5, 11
• educate patients about the importance of the medication and the need to take it
consistently;
• consider a weekly-dosed oral bisphosphonate – it may improve adherence compared with
daily dosing in some patients;
• choose the most affordable and effective option;
• provide written instructions on dosing and duration of therapy;
• encourage a reminder system or use of an adherence aid such as a pill box; and
• ask about adverse effects (such as gastrointestinal side effects with bisphosphonates, or
hot flashes with raloxifene) and consider an alternative if indicated.
Monitor response to therapy
Cost may be a barrier to adherence. Generic alendronate is now available, making
bisphosphonate therapy more affordable. Injectable drugs may incur an additional up-front
expense.5
The costs of a 30-day supply of typical doses of these medications are listed below. The
price of calcium and vitamin D varies, but these medications are widely available and inexpensive
(under $10 per month).5
Cost
