5. “What will I do if I have to give up driving?”
Comments
6. “Medications are
expensive. But I
can’t afford to let
my condition get
worse and this
medicine will help
stop or slow down
the bone loss.”
Comments
7. “If somebody had
told me sooner what
I know now about
osteoporosis, none
of this might be
happening to me!”
Comments
8. OverviewOverview
Bone with
Osteoporosis
Normal
Bone
Osteoporosis
causes weak bones.
In this common
disease, bones lose
minerals like
calcium. They
become fragile and
break easily.
Source: The 2004 Surgeon General’s Report on Bone Health and Osteoporosis:
What It Means to You at http://www.surgeongeneral.gov/library/bonehealth
9. OsteoporosisOsteoporosis
The Most Common Bone DiseaseThe Most Common Bone Disease
• Characterized by low bone
mass and deterioration of
bone structure
• Not a natural part of aging
• Increased risk for women,
post-menopausal, over age
65
• All races, sexes, and ages
are susceptible
• Preventable and treatable!
10. TheThe “silent disease”“silent disease”
• Often called the
“silent disease”
• Bone loss occurs without symptoms
– First sign may be a fracture due to weakened
bones
– A sudden strain or bump can break a bone
11. OsteoporosisOsteoporosis expansionexpansion
• 1 in 2 women and 1 in 5 men over age 50 will
suffer a fracture in their remaining lifetime
• 55% of persons over age 50 are at increased risk
of fracture due to low bone mass
• At age 50, a woman’s lifetime risk of fracture
exceeds combined risk of breast, ovarian &
uterine cancer
• At age 50, a man’s lifetime risk of fracture
exceeds risk of prostate cancer
1111
12. Other factorsOther factors
• Middle East being one of the sunniest regions
worldwide, but the prevalence of hypovitaminosis D
there was among the highest in the world, reaching >
80% in adolescent girls in Saudi Arabia.
• Role of veil in our region & heat
• Lack of funds for treatment and education about the
disease
• low socio-economic status in some countries
• multiparity
1212
13. Middle EastMiddle East
• Osteoporosis is set to rise alarmingly in the
Middle East and Africa, with rates of fragility
fracture incidences expected to quadruple in
several countries as the population ages- IOF
• By 2020, 25% of the population will be over
the age of 50 – reaching 40% by 2050. This
population is particularly at risk of
osteoporosis.
1313
The Middle East and Africa Regional Audit report
14. DEMOGRAPHIC DATADEMOGRAPHIC DATA
• It is projected that by 2050, Egypt will have the
largest population in the region with close to 130
million inhabitants, which represents a 40%
increase compared to its current population and
more than 30% of its population will be aged 50
years and over.
• In Lebanon, Iran and Tunisia, nearly 40% of the
population will be 50 years old and over,
compared to 20% today in Tunisia and Lebanon
and 15% in Iran. 1414
16. Percent Population over 50 years byPercent Population over 50 years by
Country in 2050Country in 2050
1616
17. • After mid-30’s, you begin
to slowly lose bone mass.
• Women lose bone mass
faster after menopause.
• Men lose bone mass too.
Source: The 2004 Surgeon General’s Report on Bone Health and Osteoporosis:
What It Means to You at http://www.surgeongeneral.gov/library/bonehealth
18. Risk factorsRisk factors
If you have any of
these “red flags,”
you could be at high
risk for weak bones.
Talk to your health
care professional.
Source: The 2004 Surgeon General’s Report on Bone Health and Osteoporosis:
What It Means to You at http://www.surgeongeneral.gov/library/bonehealth
19. I’m older than 65
I’ve broken a bone after age 50
My close relative has osteoporosis or has
.broken a bone
My health is “fair” or “poor”
I smoke
I am underweight for my height
1
20. I started menopause before age 45
I've never gotten enough calcium
I have more than two drinks of
alcohol .several times a week
I have poor vision, even with glasses
I sometimes fall
I'm not active
2
21. I have one of these medical conditions:
Hyperthyroidism
Chronic lung disease
Cancer
Inflammatory bowel disease
Chronic liver or kidney disease
Hyperparathyroidism
Vitamin D deficiency
Cushing's disease
Multiple sclerosis
Rheumatoid arthritis
3
22. I take one of these medicines:
Oral glucocorticoids (steroids)
Cancer treatments (radiation,
chemotherapy)
Thyroid medicine
Antiepileptic medications
Gonadal hormone suppression
Immunosuppressive agents
4
23. Bone Health & Oral HealthBone Health & Oral Health
• Oral health care is important.
• Bone loss in the jaw and osteoporosis
have been linked
• The loss of bone supporting the jaw
and anchoring our teeth can lead to
loose teeth, tooth loss and ill fitting
dentures.
• Your dentist may be the first health
professional to suspect osteoporosis.
• Women with osteoporosis have been
reported to have 3 x more tooth loss
than women without the disease.
25. Hip FracturesHip Fractures
• Outcomes
– Fracture related outcomes
• Healing
• Quality of reduction
– Functional outcomes
• Ambulatory ability
• Mortality (25% at one year for age > 50)
• Return to pre-fracture activities of daily living
26. 26
DISEASE
BURDEN
MECHANISM
OF DISEASE
UNMET NEEDS
LIMITATIONS
OF THERAPIES
IDENTIFYING
FRACTURE RISK
HOME DENOSUMAB
DOWNLOAD
REFERENCES
Cortex Thinning in Patients with Hip Fractures
1. Poole KE, et al. PLoS One. 2012;7:e38766
In patients with acute hip fracture, the cortex was generally thinner
in the femoral neck vs age- and sex-matched controls.
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27. 27
DISEASE
BURDEN
MECHANISM
OF DISEASE
UNMET NEEDS
LIMITATIONS
OF THERAPIES
IDENTIFYING
FRACTURE RISK
HOME DENOSUMAB
DOWNLOAD
REFERENCES
Kaplan–Meier survival curves for the general population
and fracture populations according to fracture type and
age (data from the Dubbo Osteoporosis Epidemiology
Study)
Fragility Fractures Are Associated With Increased Mortality
Previous Next
Years
1.0
0.8
0.6
0.4
0.2
0
0 5 10 15 20
General population
Vertebral fracture
Hip fracture
Age >75 years
Log-rank P > 0.001
Men Women
Years
1.0
0.8
0.6
0.4
0.2
0
0 5 10 15 20
28. 28
DISEASE
BURDEN
MECHANISM
OF DISEASE
UNMET NEEDS
LIMITATIONS
OF THERAPIES
IDENTIFYING
FRACTURE RISK
HOME DENOSUMAB
DOWNLOAD
REFERENCES
Fragility Fractures Significantly Reduce Quality of Life
Bianchi ML et al. Health Qual Life Outcomes. 2005;3:78.
Previous Next
*†
*†
*†
*†
*†
**
90
80
70
60
50
40
30
20
10
0
100
QP with fractures
QP without fractures
Controls
Pain Physical
Function
Social
Function
Health
Perception
Mental
Function
Global
Score
*P < 0.005; OP with fractures vs OP without fractures
**P < 0.05; OP without fractures vs OP controls
*†
P < 0.005; OP with fractures vs OP controls
Qualeffo-41 domain
**
**
29. 29
DISEASE
BURDEN
MECHANISM
OF DISEASE
UNMET NEEDS
LIMITATIONS
OF THERAPIES
IDENTIFYING
FRACTURE RISK
HOME DENOSUMAB
DOWNLOAD
REFERENCES
40%
Incapable of walking
independently
30%
Permanent
Discapacity*
20%
Die within
the first
year
80%
One Year After a Hip Fracture
Patients(%)
Not able to independently do at
least one daily life activity done
before the fracture
Hip fractures are associated with morbidity, permanent discapacity, lack of
ability to walk independently and complete daily life activities
1. Cooper C. Am J Med. 1997;103:12s17s.
2. *Refers to patients that are care dependent or have to move into a nursing home for the first time
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30. 30
DISEASE
BURDEN
MECHANISM
OF DISEASE
UNMET NEEDS
LIMITATIONS
OF THERAPIES
IDENTIFYING
FRACTURE RISK
HOME DENOSUMAB
DOWNLOAD
REFERENCES
Premenopausal Osteoporotic
Trabecular Bone
•Sponge-like network of
delicate plates of bone
•20% of skeletal mass
Cortical Bone
•Dense outer shell of
compact bone; defines
bone shape
• 80% of skeletal mass
Cortical Bone Thinning
and Cortical Porositya
Trabecular Bone Loss
a
Cortical porosity is defined as the pore volume of cortical bone
1. Riggs BL, et al. N Engl J Med. 1986;314:1676-1686. 2. Dempster DW. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and
Disorders of Mineral Metabolism. 6th ed. Washington, DC: American Society for Bone and Mineral Research; 2006:7-11. 3. Burghardt AJ,
et al. J Bone Miner Res. 2010;25:983-993. 4. Davison SK, et al. Semin Arthritis Rheum. 2006;36:22-31.
Osteoporosis Can Occur in Both Cortical and Trabecular Bone
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31. 31
Special considerations in fixation
of fragility fractures
•Arthroplasty / Hemiarthroplasty
» Also allows early mobilization
•Implants designed for osteoporotic bones
» Fixed angles locking plate
» HA coated screws
•Use of IM nails instead of plates & screws for diaphyseal
fractures
•Void filling with cement or bone graft 31
33. 33
Distal Radius
– Very common fracture in
the elderly
– Result from low energy
injuries
– Incidence increases with
age, particularly in
women
– Associated with
dementia, poor eyesight
and a decrease in
coordination
34. 34
Distal Radius- Epidemiology
– Increasing in incidence
oEspecially in women
– 125/100,000
– Peak incidence in females 60-70
– Lifetime risk is 15%
– Most frequent cause: fall on outstretched arm
– Decreased bone mineral density is a factor
35. 35
Distal Radius - Treatment
– Results are variable and depend on fracture type and
reduction achieved
– Minimally displaced and fractures in which a stable
reduction has been achieved result in good functional
outcomes
37. 37
Vertebral Compression Fractures
Epidemiology
– Estimated that only 1/3 of
vertebral fractures come to clinical
attention – highly underreported
– Prevalence similar for men and
women age 60-70
– 117/100,000
– A 50 year old white woman has a
16% lifetime risk of experiencing a
vertebral fracture
Image courtesy of International Osteoporosis Foundation
38. 38
Vertebral compression fracture
lebanon
•In a population-based sample, of subjects aged 65-84
years, the prevalence of vertebral fractures was estimated
at 19.9% in women and 12.0% in men.
•the annual incidence of vertebral fractures in women was
estimated at 1.5%
• 2,490 women aged 65 and above sustaining a vertebral
fracture per year.
38
ME_Audit- Lebanon
40. 40
Vertebral Compression Fractures
–Present with acute back pain
–Tender to palpation
–Neurologic deficit is rare
•Patterns
–Biconcave (upper lumbar)
–Anterior wedge (thoracic)
–Symmetric compression (T-L
junction)
41. 41
Vertebral Compression Fractures
-Treatment
–Simple osteoporotic vertebral compression fractures
are treated non-operatively and symptomatically
–Prolonged bed rest should be avoided
–Progressive ambulation should be started early
–Back exercises should be started after a few weeks
53. 53
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
When the RANK Ligand Exceeds the OPG, Bone Resorption can
Become Excessive Leading to Osteoporosis
Osteoblasts
CFU-M Pre-Osteoclasts
Multinucleated
Osteoclasts
RANKL
RANK
OPG
Bone Formation
Bone Resorption
.
In the Presence of M-CSF
CFU-M= Unidad formadora de colonias de macrófagos
M-CSF= Macrophage Colonies Stimulator Factor
Increased RANKL
Stimulates
Differentiation,
Function, and
Survival of OCs
Adapted from de Boyle WJ, et al. Nature. 2003;423:337-342.
54. 54
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
Denosumab is an Anti RANKL MAb That Mimics the Action of OPG
Inhibiting Formation, Function and Survival of OCs
Hormones
Growth Factors
Cytokines
RANKL
RANK
OPG
DENOSUMAB
Bone Formation Inhibited Bone
Resorption
M-CFU Pre-Osteoclasts
Osteoblasts
In the Presence of M-CSF
CFU-M= Unidad formadora de colonias de macrófagos
M-CSF= Macrophage Colonies Stimulator Factor
Denosumab has the same effect of OPG
blocking RANKL
and inhibiting bone resorption
Adapted from de Boyle WJ, et al. Nature. 2003;423:337-342.
55. 55
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
Study population
• 7808 postmenopausal women
• T-score < –2.5 at the lumbar
spine or total hip and
not < –4.0 at either site
Primary endpoint
• New vertebral fracture at
36 months
Secondary endpoints
• Time to first
non-vertebral fracture
• Time to first hip fracture
Placebo
n = 3906
Denosumab
60 mg SC Q6M
n = 3902
S
C
R
E
E
N
I
N
G
E
N
D
O
F
S
T
U
D
Y
Calcium and Vitamin D
R
A
N
D
O
M
I
Z
A
T
I
O
N
Day 1
Visit
36 Months
Q6M = once every 6 months.
Cummings SR, et al. N Engl J Med. 2009;361:756-765.
•International, randomized, double-blind, placebo-controlled study
Pivotal Phase 3 Trial
Study Design
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56. 56
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
The Effect of Prolia®
(denosumab) on Fracture Risk at 36 Months
Pivotal Phase 3 Trial
*Composite measurement excluding pathological fractures and those associated with severe trauma, fractures of the vertebrae, skull, face,
mandible, metacarpals, fingers and toes.
RRR = relative risk reduction. ARR = absolute risk reduction.
Cummings SR, et al. N Engl J Med. 2009;361:756-765.
RRR = 40%
p = 0.04
RRR = 20%
p = 0.01RRR = 68%
p < 0.0001
8.0%
6.5%
1.2%0.7%
7.2%
2.3%
0
1
2
3
4
5
6
7
8
9
Non-vertebral*
ARR = 1.5%
Hip
ARR = 0.3%
IncidenceatMonth36(%)
Denosumab
Placebo
New Vertebral
ARR = 4.8%
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57. 57
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
Exposure-adjusted Subject Incidence of Adverse Events
(Rates Per 100 Subject-years)
N = number of subjects who received ≥ 1 dose of investigational product. Treatment groups are based on the original randomized treatments
received in FREEDOM. AEs coded using MedDRA v13.0. Cumulative osteonecrosis of the jaw cases: 6 cross-over, 7 long-term. Cumulative
atypical femoral fracture cases: 1 cross-over, 1 long-term.
FREEDOM Years 1–3 Extension Years 1–7
Placebo
(N = 3883)
Cross-over Denosumab
(N = 2206)
Long-term Denosumab
(N = 2343)
All AEs 156.1 96.8 97.0
Infections 30.7 20.7 19.9
Malignancies 1.6 2.0 2.0
Eczema 0.6 0.9 0.9
Hypocalcemia < 0.1 < 0.1 < 0.1
Pancreatitis < 0.1 < 0.1 < 0.1
Serious AEs 10.4 10.1 10.3
Infections 1.3 1.4 1.5
Cellulitis or erysipelas < 0.1 < 0.1 < 0.1
Fatal AEs 0.8 0.8 0.8
Osteonecrosis of the jaw 0 < 0.1 < 0.1
Atypical femoral fracture 0 < 0.1 < 0.1
Extension Years 1–7
Cross-over Denosumab (N = 2206) Long-term Denosumab (N = 2343)
Year 1 2 3 4 5 6 7 1 2 3 4 5 6 7
Serious
infections
1.6 1.5 1.1 1.6 1.3 2.2 2.1 1.3 1.2 1.7 2.4 1.2 1.5 2.6
Malignancies 1.9 1.7 2.1 2.8 2.2 2.6 2.7 1.9 2.5 1.9 2.8 1.7 2.6 1.6
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61. 61
MECHANISM
OF ACTION
EFFICACY
CLINICAL
BENEFITS
TRANSITIONING
PATIENTS
DRUG
HOLIDAYS
OSTEOPOROSISHOME
LONG TERM
SAFETY
DOWNLOAD
REFERENCES
Good Adherence Leads to a Reduction in Fracture Rates
In order to get significant fracture risk reduction MPR above 75% are needed.
Compliance rates below 50-60% do not lead to fracture risk reduction
0.07
0.08
0.09
0.10
0.11
0 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00
0.12
Fracture probability in bisphosphonate treated patients after 24 months
(35537 patients)
No Fracture
Reduction
Medication Possession Ratio (MPR)*
FractureProbability
Fracture
Reduction
*MPR is a way to assess treatment compliance using percentage of time the medication was available to the patient
Siris ES et al. Mayo Clin Proc. 2006;81:1013-1022.
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62. Technical challenges ofTechnical challenges of
fracture fixation in osteoporoticfracture fixation in osteoporotic
bonebone
• Impaired ability of osteoporotic bone to hold screws or
support implants
• Crushing of cancellous bone with subsequent voids after
fracture reduction
6262
These factors can lead to a higher risk of failure at
the implant-bone interface before healing achieved
63. The good news: Osteoporosis isThe good news: Osteoporosis is
preventable for most people!preventable for most people!
• Healthy diet and
lifestyle are
important for BOTH
men and women.
• If you have
osteoporosis, your
doctor can detect
and treat it
65. Step 1Step 1
Get your daily
recommended
amounts of calcium
and vitamin D.
Use MyPyramid.gov
to help plan an
overall healthy diet
66. Step 2Step 2
Be physically
active everyday
Improve strength
and balance
Even simple activities such as
walking, stair climbing and
dancing can strengthen bones.
67. Step 3Step 3
Avoid smoking
and excessive
alcohol. 12 oz. 5 oz.
1.5 oz.
MyPyramid.gov recommends
no more than 1 drink per day
for women and 2 for men.
69. Step 5Step 5
Have a bone density
test
and take medication
when appropriate.
Sourceofphoto:USDAARSPhotoUnitPhotobyPeggyGreb
Testing is a simple,
painless procedure.
70. Calcium Requirements for 50+ YearsCalcium Requirements for 50+ Years
Source: The 2004 Surgeon General’s Report on Bone Health and Osteoporosis:
What It Means to You at http://www.surgeongeneral.gov/library/bonehealth
Over 50 years 1,200 mg Goal
71. Nutrition labels & calciumNutrition labels & calcium
• FDA uses “Percent Daily Value”
(% DV) to describe amount of
calcium needed by general U.S.
population daily
• 100% DV for calcium
= 1,200 mg
• Look for this label:
– “Nutrition Facts” on foods
– “Supplement Facts” on
vitamin/mineral supplements
72. Calcium & vitamin D recommendationsCalcium & vitamin D recommendations
• 51 - 70 years
1,200 mg calcium (120% DV)
400 IU vitamin D (100% DV)
• 70 and older
1,200 mg calcium (120% DV)
600 IU vitamin D (150% DV)
73. Percent Daily Value (DV) ofPercent Daily Value (DV) of
calcium in common foodscalcium in common foods
Approximate % DV for foods based in part on The 2004 Surgeon General’s Report on Bone Health and
Osteoporosis: What It Means to You at http://www.surgeongeneral.gov/library/bonehealth
74. % DV calcium:% DV calcium: Milk groupMilk group
• Yogurt
1 cup (8 oz.) = 30% DV
• Milk
1 cup = 30% DV
• Cheese
1 ½ oz. natural/2 oz. processed = 30% DV
• Milk pudding
1/2 cup = 15% DV
• Frozen yogurt, vanilla, soft serve
½ cup = 10% DV
• Ice cream, vanilla
½ cup = 8% DV
• Soy or rice milk, calcium-fortified
1 cup = varies—check label
Choose fat-free
or low fat
most often
75. What about Vitamin D?What about Vitamin D?
Main dietary sources of vitamin D are:
• Fortified milk
(400 IU per quart)
• Some fortified cereals
• Cold saltwater fish
(Example: salmon, halibut, herring,
tuna, oysters and shrimp)
• Some calcium and vitamin/mineral
supplements
76. Vitamin D from sunlight exposureVitamin D from sunlight exposure
• Vitamin D is manufactured in your skin
following direct exposure to sun.
• Amount varies with time of day, season,
latitude and skin pigmentation.
• 10–15 minutes exposure of hands, arms
and face 2–3 times/week may be
sufficient (depending on skin sensitivity).
• Clothing, sunscreen, window glass and
pollution reduce amount produced.
Source: National Osteoporosis Foundation Web site; retrieved July 2005 at http://www.nof.org
77. Help for the lactose-intolerantHelp for the lactose-intolerant
Some people lack the
enzyme lactase
needed to digest
lactose
(milk sugar).
78. When you donWhen you don’t like to “drink”’t like to “drink”
milkmilk
80. Vitamin D necessary forVitamin D necessary for
calcium absorptioncalcium absorption
• Choose a supplement with vitamin
D unless obtaining vitamin D from
other sources.
• Follow age group
recommendation. Avoid going
over a daily combined total of
2,000 IU or 50 mcg from food
and supplements.
• It’s not necessary to consume
calcium and vitamin D at the same
time to get the benefit of enhanced
calcium absorption.
Vitamin D is like a key
that unlocks the door
and lets calcium
into the body.
81. Limit calcium to 500 mg at a timeLimit calcium to 500 mg at a time
Our bodies can best
handle about 500
mg calcium at one
time from food
and/or supplements.
Spread your calcium
sources throughout
the day.
82. Increase amount slowlyIncrease amount slowly
• Start supplements with 500 mg calcium daily
for about a week, gradually adding more.
• Gas and constipation can be side effects:
– Increase fluids and high fiber foods if diet is low in
whole grains and fruits and vegetables.
– Try a different type of supplement if side effects
continue.
84. PreventionPrevention
• Strategies focus on controlling factors
that predispose to recurrent fracture
– Consider bone mineral density test
– Rule out secondary causes of
osteoporosis
– Initiate and monitor therapy, or refer
• Fall prevention
85. Hip Fracture Prevention: FallingHip Fracture Prevention: Falling
How do Younger Adults Fall?How do Younger Adults Fall?
86. Hip Fracture Prevention: FallingHip Fracture Prevention: Falling
How do Older Adults Fall?How do Older Adults Fall?
91. Scc – forever young programScc – forever young program
• Hi- tech rehabilitation program for 50 +
• Use the most advanced & computerized machines to
stimulate muscles, increase activities & Coordination
• Prevents falls and walking instabilities
9191
94. ConclusionsConclusions
• Prevention is multifaceted: a fragility fracture is the
strongest predictor of a future fracture
• Cost containment is a joint effort between orthopaedists,
primary care physicians, PT and social work
• Functional outcome is maximized by early fixation and
mobilization in operative cases
• With the increasing population of elderly, orthopaedic
surgeons must be proactive in secondary prevention of
fragility fractures
FYI do not have to announce to group-
1st picture – 50 year old postmenopausal with hot flashes
2-3 picture postmenopausal- 55+ At greater risk for vertebral fractures than any other type of fracture.
Last picture: 75 year old + with kyphosis: at risk for hip and vertebral fractures
With Osteoporosis your body’s frame (bones)
becomes like the frame of a house damaged by termites
Weak bones break easily
May never walk again
Can even be fatal
Fragile bones are not painful at first
Your dentist will take your medical history, discuss oral health risk factors and review clinical & x-ray examinations at your dental visits.
PRESENTATION TIP:
In this module, the potential role of the orthopaedic surgeon in managing patients with osteoporosis and fragility fractures is introduced.
Key Point
fractures are linked with substantial morbidity and have a considerable impact on quality of life.1
Supplemental Information
Mortality is ~20% in excess of that expected 5 years after hip or vertebral fracture; most excess deaths occur in the first 6 months after hip fracture.1
Mortality rate is highest in men &gt;75 years with a variety of chronic comorbidities.1
One year after hip fracture:1
27% enter a nursing home for the first time
40% of Patients are still unable to walk independently
60% have difficulty with at least one essential activity of daily living
80% are restricted in other activities, such as driving and grocery shopping.
Ideally, follow-up should be driven by morbidity, rather than by the radiological finding of a new fracture.1
Reference
1. Cooper C. Am J Med 1997;103:12s-17s.
This slide shows a cross-section of the hip.
References:
Riggs BL, Milton LJ 3rd. Involutional osteoporosis. N Engl J Med. 1986;314:1676-1686.
Dempster DW. Chapter 2. Anatomy and functions of the adult skeleton. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 6th ed. Washington, DC: American Society for Bone and Mineral Research; 2006:7-11.
Burghardt AJ, Kazakia GJ, Sode M, de Papp AE, Link TM, Majumdar S. A longitudinal hr-pqct study of alendronate treatment in post-menopausal women with low bone density: relations between density, cortical and trabecular micro-architecture, biomechanics, and bone turnover. J Bone Miner Res. 2010;25:983-993.
Davison SK, Siminoski K, Adachi JD, et al. Bone strength: the whole is greater than the sum of its parts. Semin Arthritis Rheum. 2006;36:22-31.
SPEAKER NOTES:
Osteoporotic fractures have other adverse consequences, and there may be a cascade of morbid effects.
For example, many forearm fractures occur soon after menopause. The resulting disability is usually limited, but patients may then experience subsequent vertebral fractures, which may be severe and are likely to result in height loss, postural changes, and chronic pain.
Patients with spine and forearm fractures are also at increased risk of hip fractures, which typically occur late in life.
Hip fractures often result in global disability and the need for nursing home admission; few patients regain their prefracture level of function.
PRESENTATION TIPS:
This graphic represents the concept that in a patient with osteoporosis, multiple fractures (rather than a single fracture) are typical, and each fracture results in increasing potential for morbidity and loss of function.
REFERENCE:
Kanis JA, Johnell O. The burden of osteoporosis. J Endocrinol Invest. 1999;22(8):583588.
PRESENTATION TIP:
In this module, the potential role of the orthopaedic surgeon in managing patients with osteoporosis and fragility fractures is introduced.
Paget’s dose: alendronate 40 mg/day x 6 mo., risedronate 30 mg/day x 2 mo.
FDA advisory board found that evidence did not support calcitonin salmon for the
treatment of osteoporosis (March 5, 2013)
Key Points
The pivotal phase 3 trial was a 3-year, international, randomized, placebo-controlled study that enrolled 7808 postmenopausal women
Eligible patients were between 60 to 90 years of age, and had lumbar spine and/or total hip BMD T-score –2.5 and not –4.0 at either site
Patients were excluded if they had
A BMD T-score –4.0 at the lumbar spine or total hip or any severe (or more than two moderate) prevalent vertebral fractures
Conditions that influence bone metabolism
Taken oral bisphosphonates for longer than 3 years (patients on oral bisphosphonates for less than 3 years were eligible after 12 months without treatment)
Used IV bisphosphonates, fluoride, or strontium for the treatment of osteoporosis within 5 years
Used parathyroid hormone (PTH) or its derivatives, steroids, systemic hormone replacement therapy, selective estrogen receptor modulators (SERMs), tibolone, calcitonin, or calcitriol within 6 weeks of enrollment
25 (OH) vitamin D level 12 ng/mL
Following screening, patients were randomized (1:1) to either 60 mg denosumab SC Q6M or placebo for 3 years
All patients received 1000 mg of calcium; patients also received vitamin D at doses based on baseline 25 (OH) vitamin D level
Baseline 12–20 ng/mL: received 800 IU vitamin D daily
Baseline 20 ng/mL: received 400 IU vitamin D daily
Reference
Cummings SR, Martin JS, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756-765.
Key Points
In the analysis of the primary endpoint, the relative risk of new vertebral fractures was 0.32 for denosumab vs placebo, representing a 68% relative reduction (p 0.0001) and a 4.8% absolute reduction1,2
The percentages of new vertebral fractures were calculated for 3702 subjects in the denosumab group and 3691 in the placebo group who underwent spinal radiography at baseline and during at least one visit after baseline; the percentages of nonvertebral and hip fractures were cumulative Kaplan-Meier estimates for 3902 subjects in the denosumab group and 3906 in the placebo group
The relative risk of denosumab vs placebo1
For nonvertebral fractures was 0.80, representing a 20% relative reduction (p = 0.01) with a 1.5% absolute reduction
For hip fractures was 0.60, representing a 40% relative reduction (p = 0.04) with a 0.3% absolute reduction
Analysis of efficacy was based on intent-to-treat principle1
The study was designed to maintain an overall significance level at 0.05 despite the multiple comparisons1
Statistical significance of the primary endpoint was required before the secondary endpoints would be analyzed
The absolute risk reduction was calculated based on the difference in incidence at month 36 for the primary endpoint
The difference in the Kaplan-Meier estimates at month 36 was used to calculate the absolute risk reduction for the secondary endpoints
References
Cummings SR, Martin JS, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756-765.
PRESENTATION TIP:
In this module, the potential role of the orthopaedic surgeon in managing patients with osteoporosis and fragility fractures is introduced.
Over 50 – need 1200 mg of calcium per day or 120% of the “Nutrition Fact” food label on packaged foods
Between 51 and 70 – need 400 International Units (IU) of vitamin D
Over 70 – need 600 IU of Vitamin D
Vitamin D helps your body absorb calcium
Calcium is critically important to bone health
Strength training, including light weights, 2 – 3 times per week
At least 30 minutes of physical activity per day
Any activity that puts stress on bones keeps them strong
walking, gardening, dancing, running
Balance training at least once per week
Examples:
Yoga
Pilates
Tai Chi
One-leg balances
Toe walking
Forward-backward leg swings with knee flexed
The physical activity will also strengthen your body – leads to fall reduction
Benefits of exercise only last as long as the exercise is part of a regular routine
Be sure to discuss
Your risk factors
Your medication
Calcium & vitamin D intake
Do you need a bone density scan
Discuss significant risks with a health care professional
Medications
Family history
Recent falls or broken bones
All Women - BMD/DXA &gt; 65 years. Physicians decision!
Men - BMD/DXA –. Guidelines for DXA only address postmenopausal women. NOF recommends all men over age 70 years have a bone density scan. Physician decision!
Senior adults over age 70 have the greatest need for vitamin D and are less able to make vitamin D from sunlight. Seniors need to be sure to consume enough vitamin D. It is difficult for many seniors to get enough vitamin D from foods and therefore a supplement may be needed. There is some evidence that the intake of 800 IU/day of vitamin D (or more) along with adequate calcium may reduce the risk for falls (by increasing muscle strength) and reduce the risk for fracture in postmenopausal women and seniors. All at-risk individuals should follow the advice of their medical professional to get enough vitamin D through either food and/or supplements.
Start with small portions of foods such as milk and gradually increase serving size.
Eat dairy foods in combination with a meal or solid foods.
Try dairy foods other than milk:
Many hard cheeses (cheddar, Swiss, Parmesan) have less lactose than milk
Yogurt made with live, active bacteria
It may be easier to digest lactose that is pre-digested
Try
Lactose-hydrolyzed milk and dairy products
Commercial lactase preparations
Make oatmeal and cream-type soups with milk instead of water
Add powdered milk to food(1 tablespoon = 50 mg calcium)
Add milk to coffee
Serve milk-based desserts (puddings, tapioca, frozen yogurt, custard, ice cream).
Limit fat and sugar.
Try chocolate milk.
8-oz. has only 2 - 7 mg caffeine.
Average glass provides only 60 more calories than unflavored milk.
Make instant hot cocoa with milk, not water.
Top baked potatoes with plain yogurt; sprinkle with chives
Enjoy plain or flavored low fat yogurt straight from the carton or combined
Used flavored yogurt as a fruit salad dressing; experiment with substituting plain yogurt for some or all of the sour cream in vegetable salad dressings
This is one of the ways patients fall.
Backward and lateral falls also occur and put the patient at risk for fractures.
Osteoporotic fractures commonly affect the hip because the elderly tend to fall sideways or backwards, landing on this joint. Younger, more agile persons tend to fall forward, landing on the outstretched wrist, thus fracturing the distal radius
Have handrails and plenty of light in all stairways.
Wear shoes that give good support and have non-slip soles.
Don’t use stepstools. Keep items you need within easy reach.
Maintain a clear path to the bathroom
Remove all small rugs. They can make you trip.
Make sure your walkways are wide enough.
Remove things that you may trip over from stairs and places where you walk.
Move phone and electrical cords away from walkways and open areas.
Make sure that all areas are well lit. Use bright light bulbs.
Be aware that some medications, including over-the-counter medicines, can make you dizzy or sleepy.
Get your vision checked
PRESENTATION TIP:
If there is more interest in this topic, access the deep dive slides on Fracture Liaison Services by clicking on the button in the bottom left corner of the slide.