Transcript Fracture risk assessment and risk reductionx

Falls and Fracture
Risk assessment
and management
Disclosures:
Although various guidelines and studies were
reviewed, this represents my own personal
bias and conclusions.
What do we know?
1) Fractures are bad, worse in the elderly, especially hip
fractures.
2) There are multiple factors leading to increased fracture
risk, the obvious ones being age and risk of falls.
3) There are industry funded studies that demonstrate
significant fracture reduction with medications.
4) There are numerous guidelines out there – BC, National,
US (NOF), UK (NOGG), UK (NICE), European, Australian.
What do we know?
5) There are multiple fracture risk assessment tools- FRAX,
QFracture, Garvan, CAROC.
6) There are significant healthcare costs involved- BMD
scans, medication costs, hospitalization and physician costs
not to mention quality of life issues.
7) The decision to treat lies with the patient and we need to be
able to provide objective information to the patient to help
guide their decision.
BC guidelines
• http://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/bcguidelines/osteoporosis
• http://www2.gov.bc.ca/assets/gov/health/practitioner-pro/bcguidelines/osteoprosis_summary.pdf
Osteoporosis Canada
• http://www.osteoporosis.ca/multimedia/pdf/Quick_Reference_Guide_October_2010.pdf
NOF
• http://nof.org/files/nof/public/content/file/2791/upload/919.pdf
NOGG
• https://www.shef.ac.uk/NOGG/NOGG_Pocket_Guide_for_Healthcare_Professionals.pdf
NICE
• https://www.nice.org.uk/guidance/TA160/chapter/1-Guidance
European
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3587294/
Australian
•
http://www.racgp.org.au/download/documents/Guidelines/Musculoskeletal/op_algorithm.pdf
•
http://www.racgp.org.au/afp/2012/march/osteoporosis-pharmacological-prevention-andmanagement/
So where do we start?
Basic principles
Fracture Risk Assessment
• The most studied and validated tool is the WHO FRAX
tool.
• There is a specific Canadian cohort for the FRAX.
• It has its limitations, but is simpler to use than the others
(fewer inputs).
• Despite it being a WHO tool, the formula is proprietary
through the University of Sheffield and although use of the
online calculator is free, to be able to use the tool on your
desktop you have to pay a license fee.
• The tool can be used with and without a BMD value.
https://www.shef.ac.uk/FRAX/
Falls Risk Assessment
• There are many comprehensive tools out there, most require
some basic equipment and a stopwatch and look to take 15-30
min to complete.
However, there is one tool:
• Fracture Risk Assessment Tool-FRAT,
• that has been produced specifically for the use in a GP office
and will take less than one minute.
http://www.bhps.org.uk/falls/documents/FRATtool.pdf
Fracture risk reduction
Probably the basic interventions are the most important interventions:
1) Encourage maintaining an active lifestyle and include activities to
improve leg strength and balance: 30-60min of walking per day.
2) Encourage proper technique when lifting: keep your back straight
rather than bent.
Also, consider whether the object to be lifted can be divided into smaller
portions before lifting.
3) Ensure adequate daily intake of both calcium (generally about 10001200 total mg/day) and vitamin D (about 1000 IU/day).
4) Reduce risk for falls: Having a fall is the single
greatest risk for breaking a bone.
a) Review medications regularly
Polypharmacy (greater than 3 medications) is independent risk factor
Common culprits
Antidepressants
Antipsychotics
Benzodiazepines
Sedatives
Antihypertensive
NSAID
Diuretics
B-Blockers
Narcotics
OR
1.68
1.59
1.57
1.47
1.24
1.21
1.07
1.01
0.96
Percentage increase
68%
59%
57%
47%
24%
21%
7%
1%
- (CI 0.78-1.18)
Woolcott J., Richardson K., Wiens M., Patel B., Marin J., Khan K., et al. . (2009) Meta-analysis of the impact
of 9 medication classes on falls in elderly persons. Arch Intern Med 169: 1952–1960
b) Encourage regular vision checks.
c) Consider home assessment for the high risk patient by the FHA Mobile
Falls Prevention team.
http://www.cdc.gov/HomeandRecreationalSafety/Falls/WhatYouCanDoToPreventFalls.html
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125318/#bibr55-2042098613486829
5) Medications to strengthen bones:
Commonest used in general practice are the bisphosphonate group.
Bisphosphonates target the areas of higher bone turnover. The osteoclast cells
absorb the bisphosphonate drug, which slows down their activity and reduces bone
break down.
There are several different types of bisphosphonates, and they each work slightly
differently.
We know that they can
• Interfere with the formation of osteoclasts
• Make osteoclasts self destruct, or die early
• Change the signalling between osteoclasts and osteoblasts
• Form a barrier between the bone and the osteoclast
Tolerability of bisphosphonates:
• GIT adverse effects
Results: A total of 11% of the alendronate patients and 13% of the placebo
patients reported an upper GI tract adverse event. Discontinuations due to
drug- related upper GI tract adverse events occurred in 3% of alendronate
patients and 1% of placebo patients.
Results: Of 438 patients who were randomized, 367 completed the study. The
proportions of patients who experienced an upper GI AE during the study
period were 66 (22.7%) and 30 (20.4%) for alendronate vs placebo.
• Renal impairment
Both oral and intravenous bisphosphonates are not recommended when
eGFR is < 30 (<35 for IV).
Some of the rare serious side effects:
• Osteonecrosis of the jaw
• It has been estimated that the risk of ONJ is approximately 1 in 10,000 to 1
in 100,000 patient-years in patients taking oral bisphosphonates for
osteoporosis.
• Atypical Femur Fractures
• Although long-term use (median treatment seven years) of
bisphosphonates increases the RR of atypical fractures, the absolute risk is
low (3.2 to 50 cases per 100,000 person-years). The risk may rise with
duration of bisphosphonate exposure (100 per 100,000 person-years).
When bisphosphonates are stopped, the risk of atypical fracture declines.
There are many industry sponsored trials. I have reviewed the
FIT ,VERT-NA and HORIZON trials as these appear to be the
original trials of note for bisphosphonates:
“A single, annual intravenous (IV) infusion of zoledronic
acid can decrease the risk of vertebral fracture by 70%
and the risk of hip fracture by 41% among women with
osteoporosis, according to the 3-year results of the Health
Outcomes and Reduced Incidence with Zoledronic Acid
Once Yearly (HORIZON) Pivotal Fracture Trial. The
results were published in the New England Journal of
Medicine (NEJM).”
HORIZON Trial (Aclasta/Zoledronic acid)
• 7765 women 65-89yrs (mean 73yrs) over 3 yrs
• Tscore < -2.5 or Tscore <-1.5 and vertebral fracture
• Morphometric vertebral #: 3.3% cf 10.9% RRR 70% ARR 7.6%
• Hip fracture:
1.4% cf 2.5% RRR 41% ARR 1.1%
FIT trial Sponsor—Merck Research Laboratories
• 3658 Women aged 55-80yrs
• Average age 70yrs
• Alendronate 5mg daily increased to 10mg daily plus 500mg Ca and 250iu
Vit D
• Femoral neck T-score <-2.5 or previous vertebral fracture
• 3-4 yrs of treatment, effect noted within 12 months
Fracture reduction:
RRR
Hip
53%
Vertebral (radiological) 48%
Vertebral (clinical)
45%
All fractures
30%
ARR
1.2%
7.2%
2.3%
5.5%
http://press.endocrine.org/doi/full/10.1210/jcem.85.11.6953
VERT-NA Residronate - Procter & Gamble
•
•
•
•
•
Started with 2458 women <85yrs
All had vertebral fracture seen on screening Xray
Average age 70yrs
Ended up with 949 women, 3 years of treatment
Residronate 5mg daily plus Ca 1000mg and up to 500iu Vit D if
indicated
Fracture reduction:
Vertebral(radiological)
Non vertebral
RRR
41%
39%
ARR
4%
3.2%
http://jama.jamanetwork.com/article.aspx?articleid=191987
Summary based on these trials:
• For females around age of 70yrs with either a prior vertebral
fracture or a BMD < -2.5 (ie evidence of osteoporosis), taking a
bisphosphonate will reduce the:
ABSOLUTE risk of
• Hip fractures by about 1%
• Vertebral (clinical) fractures by about 2%
• All fractures (include radiological) by about 5%.
Most guidelines focus on the RRR (53%/45%/30%) and then apply
these numbers to the risk calculated by the FRAX tool (10yr
predication) which leads to some interesting results.
Cochrane review of fracture risk prevention
with bisphosphonates:
• Note that their definition of “secondary prevention” includes patient with
low bone mass.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001155.pub2/abstract;jsessio
nid=984707094936288431A1897617796A0B.f01t02
Goals of this Fracture Risk Assessment Tool
1) To facilitate appropriate screening of patients for
increased fall and fracture risk.
2) Use these results to remind us to address the various
physical and polypharmacy issues.
3) Provide meaningful information to present to the patient
to aid in their decision making if they are considering bone
building medications.
Lets look at some numbers from our
clinic……..
Number of patients in clinic over the age of 50 yrs:
2472
(>65yrs 1267)
Number of patients in clinic on bisphosphonates:
31
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1.4 million Canadians suffer from osteoporosis
One in four women over the age of 50 has osteoporosis
One in eight men over the age of 50 has osteoporosis
70 per cent of hip fractures are related to osteoporosis
Up to 20 per cent of hip fractures result in death
Up to 50 per cent of hip fractures result in permanent disability
More women die each year as a result of osteoporotic fractures
than from breast and ovarian cancer combined
Results for females screened in last month with the new tool
Hip Fracture Risk
Total Fracture Risk
Age
18%
38%
89
63%
65%
85
9.10%
24%
85
13%
35%
83
8.00%
22%
83
11%
32%
82
16%
35%
82
6.70%
19%
81
5.20%
16%
80
6.00%
18%
80
29%
41%
79
5.70%
17%
79
4.50%
14%
78
4.90%
15%
77
6.80%
17%
77
3.80%
13%
76
3.80%
12%
73
3.50%
16%
72
3.10%
11%
70
0.30%
9%
67
29%
78.9
Averages
11%
Results for males screened in last month
Hip Fracture Risk
Total Fracture Risk
Age
6.40%
11%
95
4.10%
8.90%
88
5.00%
10%
88
3.30%
7.80%
83
19%
26%
82
4.90%
13%
81
3.30%
8.10%
79
1.70%
5.40%
76
4.20%
7.50%
75
3.80%
17%
66
11%
81.3
Averages
6%
Lets apply some guidelines….
BC Guidelines
NOF (USA) Guidelines
Pharmacologic treatment recommendations:
• Initiate pharmacologic treatment in those with hip or vertebral
(clinical or asymptomatic) fractures.
• Initiate therapy in those with T-scores < -2.5 at the femoral neck,
total hip or lumbar spine by dual-energy x-ray absorptiometry (DXA).
• Initiate treatment in postmenopausal women and men age 50 and
older with low bone mass (T-score between -1.0 and -2.5, osteopenia)
at the femoral neck, total hip or lumbar spine by DXA and a 10-year
hip fracture probability > 3 percent or a 10-year major osteoporosisrelated fracture probability > 20 percent based on the U.S.-adapted
WHO absolute fracture risk model (FRAX®; www.NOF.org and
www.shef.ac.uk/FRAX).
NICE (UK) Guidelines
Alendronate is recommended as a treatment option for the primary prevention of
osteoporotic fragility fractures in the following groups:
• Women aged 70 years or older who have an independent clinical risk factor for
fracture or an indicator of low BMD and who are confirmed to have osteoporosis
(that is, a T-score of −2.5 SD or below).
• Women aged 65–69 years who have an independent clinical risk factor for fracture
and who are confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below).
• Postmenopausal women younger than 65 years who have an independent clinical risk
factor for fracture and at least one additional indicator of low BMD and who are
confirmed to have osteoporosis (that is, a T-score of −2.5 SD or below).
NOGG Executive
http://www.shef.ac.uk/NOGG/NOGG_Executive_Summary.pdf
• Men and women with probabilities below the lower assessment threshold can be
reassured.
• Men and women with probabilities above the upper assessment threshold can be
considered for treatment.
• Men and women with probabilities between the upper and lower assessment
threshold should be referred for bone mineral density measurements and their
fracture probability reassessed.
Guideline outcomes
Total = 20 Females
Guideline
BMD
Nothing
Rx w/o
BMD
?Final Rx?
?????
BC
11
1
8
10
NOF
(US)
19
1
0
19
NICE
(UK)
NOGG
(UK)
15
5
0
4
14
3
3
7
Modified
NOGG
7
13
0
5
Modified NOGG
7
8.5
10.5
12.5
16
20
24
85
90
23
28
29
34
42
49
35
40
• Below intervention threshold reassure
• Equal or above intervention threshold do BMD first and consider treatment if
remains equal or above the intervention threshold and femoral neck Tscore < -1.75.
All Wales Medicine Strategy Group
Evidence shows that the patients most likely to benefit from treatment with bisphosphonates are women
who have already been diagnosed with low BMD or have already had a vertebral fracture. The number of
patients that are needed to treat (NNT)in order to avoid a vertebral or hip fracture is given in Table 1.
Table 1. NNTs for alendronate plus calcium/vitamin D – taken
from NHS Highland’s Guidance for prescribing in frail adults.
Age
70–74 years
75–79 years
80–84 years
85–89 years
≥ 90 years
2-year
65
45
60
55
40
vertebral # (NNT) 2-year
hip # (NNT)
430
180
105
45
40
For example if 65 patients aged between 70 and 74 years take
alendronate plus calcium/vitamin D for 2 years, 1 vertebral fracture
will be avoided.
Logic incorporated in the tool:
1) Screen females > 65 yrs and males >75 yrs with ‘FRAX without BMD’
Repeat screening every 5yrs to age 75 then every 3 yrs to age 85 then every 2
yrs thereafter.
2) Modified NOGG thresholds used to decide on need for BMD and based on
the BMD results (both the calculated total fracture risk as well as the femoral
neck Tscore), the need for medication.
3) Threshold of 2o% is used to recommend a falls prevention program to all
ages.
Final Conclusions
• Fractures are a significant medical problem
particularly in the aging population.
• There are multiple risk factors for increasing fracture
risk, especially important are falls and lifestyle
(exercise, smoking, alcohol, caffeine).
• Bone building medications have a place but the data
is incomplete so decisions need to be made on
‘Expert opinion’ and simple common sense.
GPSC Fee code 14066
14066 Personal Health Risk Assessment
Eligible population – must have one of four risks:
Smoking Dx 786
Obesity (BMI >30 ) Dx 783
Unhealthy Eating Dx 783
Inadequate Exercise Dx 785
INTENT: Risk assessment & planning visit both for identified risks & to review
relevant recommended prevention services based on age, sex and
gender (eg. Pap, mammogram, stool OB, immunizations, etc.)
The End