Transcript Management of Osteoporosis - Christiana Care Health System

Management of Osteoporosis
Stephanie Fegley, FNP
Department of Orthopaedic Surgery
Christiana Care Health Services
March 28, 2014
Objectives:
1) Identify populations at risk for low bone density
or osteoporosis.
2) Recognize when it is appropriate to order a Bone
Density Scan (DXA) with or without Vertebral
Fracture Assessment (VFA).
3) Select appropriate pharmacologic agent for
osteoporosis management based on past
medical history and side effect profile.
4) Utilize “fragility fracture panel” to help rule out
secondary causes of osteoporosis.
Nearly an epidemic
• Reflects the amount of FF per year in the U.S.
– More than MI, CVA & breast cancer combined.
Cast Mountain
Statistics
• At least 44 million Americans are affected by
osteoporosis or low bone density.
• Due to an aging population, the number of
Americans with osteoporosis or low bone
density is expected to increase significantly.
– Up to ½ of all women will suffer a FF during their
lifetime
– Up to ¼ of all men will suffer a FF during their
lifetime
NOF 2 Million 2 Many Campaign
Cost of Osteoporosis
• Direct care expenditure from osteoporosisrelated fractures exceeds $19 billion annually.
• By 2025, the annual cost of fractures is
projected to grow to more than $25 billion, as
annual fractures surpass 3 million.
Painful, yet undertreated
• Approximately 80% of patients do not receive
recommended osteoporosis care following a
fragility fracture.
• Men, who account for 30% of fractures &
25% of cost, are particularly undertreated.
“No one’s ever died from osteoporosis”
• Nearly 25% of patients who suffer a hip fracture
die within a year.
• Those who do survive experience significant
morbidity, as many experience a loss of
independence & may require long-term nursing
home care.
• Others never return to their baseline mobility,
and will have to ambulate with a walker or cane
& are at increased risk of future falls & fractures.
Provide a “Teachable Moment”
• According to AOA, a fragility fracture should
be treated as a sentinel event. This will
provide opportunities or clinicians to educate
patients, fellow physicians & other healthcare
providers about the importance of bone
health and osteoporosis treatment.
– The best time to talk to your patient about a
fragility fracture and the likelihood of
Osteoporosis is while the fracture is fresh.
Fracture Cascade
• About 50% of people with one fracture due to
Osteoporosis will have a repeat fracture.
• The risk of fracture rises with each new
fracture, hence the “cascade effect”
– Women who have a vertebral fracture are 4x more
likely to have another fracture within the next
year, compared to women who have never
fractured.
Pathophysiology
• Age-related changes in bone
microarchitecture:
– Decreased bone volume
– Decreased trabecular thickness
– Decreased trabecular number
– Decreased connectivity
– Decreased mechanical strength
– Increased cortical porosity
Populations at risk…
• HIV/AIDS
• Ankylosing spondylitis
• Blood & bone marrow
disorders
• Breast cancer
• Cushing’s syndrome
• Eating disorders
• Emphysema
• Female athlete triad
• Gastrectomy
• Gastrointestional bypass
procedures
• Hyperparathyroidism
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Hyperthyroidism
Idiopathic scoliosis
Inflammatory bowel disease
Diabetes mellitus
Kidney disease
Lupus
Lymphoma & leukemia
Malabsorption syndromes
(i.e.- Celiac & Crohn’s disease)
Multiple myeloma
Organ transplants
Parkinson’s disease
Poor diet
More at Risk Populations…
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Post-polio syndrome
Premature menopause
Prostate cancer
Rheumatoid arthritis
Severe liver disease
Spinal cord injuries
Cerebral Vascular Accident
Thalassemia
Thyrotoxicosis
Weight loss
Medications that will Increase Risk…
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Oral glucocorticoids
Anticonvulsants
PPIs
SSRIs
TZDs
Lithium
Aromatase Inhibitors
Gonadotropin-releasing hormone agonists
Chemotherapy
Heparin
Depo-Provera
Other Factors that Increase Risk
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Low dietary Calcium intake
Vitamin D Insufficiency or Deficiency
Tobacco use in the past 12 months
Consuming > or = 3 units of alcohol per day
Sedentary lifestyle
2 or more falls in the past year
Moderate to high caffeine intake
Cheap ways to tell if your patient is at
an increased risk for fragility fracture:
• Prior history of fracture after age 50 or >, at fall
from standing height or less
• One of the “At risk populations”
• Is/has been taking one of the medications that
increase risk
• Tobacco abuse
• Drinks > or = 3 units of alcohol per day
• Sedentary lifestyle
• History of > or = 2 falls in the past year
• Check a FRAX http://www.shef.ac.uk/FRAX/tool.aspx?country=9
Fracture Risk Assessment Tool (FRAX)
• Tool developed by the World Health
Organization (WHO) to calculate fracture risk
in patients, by combining clinical risk factors
with BMD, to generate a 10 year probability of
fracture.
– 10 year probability of hip fracture
– 10 year probability of major osteoporotic fracture
(spine, forearm, or shoulder fracture)
When not to use FRAX:
• When the patient has already had a hip fracture
• When they have been on treatment for
Osteoporosis in the past 2 years
• Less than 40 years old
• Most DXA reports will include a FRAX score at the
end, if not contraindicated. This is to help the
provider determine if treatment is necessary.
DXA Report with Inappropriate use of
FRAX
Recommendations for when to order a
DXA:
• Women age 65 years and older and men age 70
and older.
• Women under 65 and men age 50-69 about
whom there is concern based on clinical risk
factor profile or FRAX score.
• Women and men of any age who have suffered a
low-impact fracture.
• Women and men of any age who are at increased
risk as a result of selected medical conditions or
treatment with specific medications.
DXA Guidelines
• DXA should be “Central DXA”, with lumbar spine
& hips (preferably both hips) scanned.
• DXA should be interpreted in accordance with
International Society for Clinical Densitometry
(ISCD)
• The final diagnosis from DXA is based on the
lowest t-score from the spine, proximal femur, or
femoral neck, whichever is lowest.
• Diagnosis from DXA in premenopausal women
and men under age 50 is based on z-scores and is
reported as normal or low bone density for age.
DXA Guidelines (cont.)
• Evaluation of the forearm(s) should be
performed if the evaluation of the spine or
hip(s) is limited or nondiagnostic.
• Absolute fracture risk assessment using FRAX
should be included in DXA reports for
appropriate patients.
Vertebral Fracture Assessment (VFA)
• Lateral spine imaging with densitometric VFA
is indicated when lowest t-score from DXA is
<1.0 and or more of the following is present:
– Women age >/= 70 years or man age >/= 80 years
– Historical height loss > 4cm (> 1.5 inches)
– Self-reported but undocumented prior vertebral
fracture
– Glucocorticoid therapy equivalent to >/= 5mg
prednisone or equivalent per day for >/= 3
months.
How should you write your script?
• Write to perform a “DXA with VFA” or “DXA
with VFA, if indicated”
• Things to consider:
– The patient has to lay on their side to have the
VFA performed, so if they have a recent fracture,
this may be too difficult/painful.
– Insurance coverage
Guidelines for follow-up DXA
• Insert Table 1 from CMG
Defining Osteoporosis by BMD
• Insert table 2 from CMG
Deciding when to treat using FRAX:
• According to the WHO, you should consider a
pharmacologic agent if:
• 10 year probability of a hip fracture is > 3%
• 10 year probability of major osteoporotic fracture (spine,
forearm, or shoulder fracture) is > 20%
Important Physical Exam Findings
• Eyes- Sclera
• Mouth- Teeth~ In OI can be normal or soft & translucent. Also if
you are considering bisphosphonate or Prolia therapy you want to
evaluate their dentition to determine increased risk for ONJ.
• Musculoskeletal- Postural changes such as kyphosis, “lengthening of
the arm-trunk axis” (describes shortening of the trunk w/
comparatively long extremities) & tenderness of the spinous
processes
• Gait- Try and sneak a peek at them walking in or out of the exam
room. Can they get up from a chair without using their hands?
• Scars- Fracture repairs they have forgotten about
• BMI < 18 increases risk
• Height at every office visit!
Determining the cause…
• Once you make the diagnosis, don’t forget to
rule out secondary causes!
– Fragility Fracture Panel:
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Serum Creatinine
Calcium
Albumin
Phosphorus
Alkaline phosphatase (ALP)
Thyroid Stimulating Hormone (TSH)
Vitamin D 25-OH
Intact Parathyroid Hormone (iPTH)
Vertebral Compression Fractures
• Approximately two-thirds are never diagnosed,
because they are written off as pain associated
with aging or arthritis.
• Think about the cascade
• Loss of height (more than 3cm/just over 1 inch)
• Sudden severe back pain in the
mid & lower spine
• Increased stoop or ‘dowager’s
hump’
Conservative Treatment for
Compression Fxs
• Self-Care at home:
• Rest
• Pain relief with NSAIDs
– May also need muscle relaxants
• Ice for 20 minutes every 60 minutes for the first week,
then can do heat or ice, which ever feels better.
• Physical therapy, when permitted~ with emphasis on
stretching & strengthening program to decrease risk for
further osteoporosis and strengthen muscles
supporting the back.
Conservative Treatment for
Compression Fxs
• Hospital Admission:
– Inpatient treatment dependant upon pain control, weakness,
ambulatory dysfunction, urinary retention, & cauda equina syndrome.
• TLSO (Thoracolumbosacral Orthosis) brace as needed, when out of
bed for comfort.
• Rest
• Pain relief with opiates (usually hydrocodone or oxycodone)
– May also need muscle relaxants
• Ice for 20 minutes every 60 minutes for the first week, then can do
heat or ice, which ever feels better.
• Physical therapy, when permitted~ with emphasis on stretching &
strengthening program to decrease risk for further osteoporosis
and strengthen muscles supporting the back.
Kyphoplasty
Vertebral Compression Fracture
Posture
Consequences of Vertebral
Compression Fractures
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Kyphosis
Loss of height
Bulging abdomen
Acute & chronic back pain
Breathing difficulties
Depression
Reflux & other GI symptoms
Limitation of spine mobility (affecting ADL &
ambulation)
• Need to use walking aid
Own the Bone
• Launched by the American Orthopaedic
Association (AOA), to help providers
drastically improve efforts of fracture
prevention.
• Christiana Care Health System have been
participating in the Own the Bone Registry
since January 1, 2012.
– OTB focuses on 10 measures for the patient with a
history of a fragility fracture
10 Own the Bone Measures
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Calcium supplementation
Vitamin D supplementation
Weight-bearing & muscle-strengthening exercise
Fall prevention education
Smoking cessation
Limiting excessive alcohol intake
Pharmacotherapy
Ordering DXA
Physician referral letter to report the patient’s fragility
fracture, risk factors, & recommendations for treatment.
• Patient education latter to explain bone health risk factors
& recommendations for treatment.
Which is the best Calcium?
• The majority of these patients should be told
to consume 1200mg of calcium per day
between diet and supplement combined.
• Dietary intake of calcium from food sources
should be encouraged as much as realistically
possible & fill the gap with a Ca supplement
when necessary.
Food Sources of Calcium
• Lowfat & non-fat dairy products are high in
calcium while certain green vegetables and
other foods contain calcium in smaller
amounts.
• Calcium fortified foods- Orange juice, cereals,
soymilk, English muffins, waffles, breads,
snacks, & bottled water.
Foods that Reduce the Absorption of
Calcium
• Foods with high amounts oxalate & phytate
reduce the absorption of Ca contained in those
foods.
– Foods high in oxalate= spinach, rhubarb & beet greens
– Foods high in phytate= legumes (pinto beans, navy
beans, peas), 100% wheat bran* (*space >/= 2 hours
after eating foods that contain bran)
• You can reduce the phytate level to get more Ca from
legumes by soaking them in water for several hours,
discarding the water, & then cooking them in fresh water.
Calcium Side Effects
• Gas or constipation may occur from Ca
supplements
• Some patients complain of nausea
• Patient’s should increase fluids & fiber in their diet, but
if that does not help, they should try another type or
brand of Ca.
• When starting a new Ca supplement, start with smaller
amounts & drink an extra 6-8 ounces of water with it,
then gradually add more Ca each week.
Calcium Supplementation
• There are many different types of calcium salts (i.e. glubionate,
gluconate, lactate, citrate, acetate, phosphate, & carbonate)
• Calcium Carbonate (40% elemental Ca)
– Viactiv, Caltrate, Oscal, Tums, numerous store brands
– 300-600mg of calcium per pill
– Requires hydrochloric acid for best absorption, therefore remind
patients to take with meals.
• Calcium Citrate (21% elemental Ca) **May need 2 pills per dose
– Citracal, some store brands
– 200-300mg of calcium per pill
– Does not requires hydrochloric acid for absorption, so it can be taken
with or without food.
• Calcium Phosphate (39% elemental Ca)
– Posture
– Absorption is very similar to Calcium Carbonate
Is There a “Best” Calcium Salt?
• The data suggests that both Calcium carbonate &
Calcium citrate, taken with meals, have equivalent
bioavailability.
• If you have a patient on a H2 blocker, PPI, or you know
has achlorhydria and supplements won’t be taken with
meals, Calcium citrate is a better choice.
• Calcium carbonate is cheaper
• Calcium phosphate is equivalent to Calcium carbonate
in supporting bone building.
• Study suggests that Calcium citrate has better
availability than Calcium carbonate after roux-en-Y
gastric bypass.
Calcium Supplements
• Most important factors are those predicting
long-term use: palatability, cost, tolerance
• Advertised “differences” more apparent than
real
• Magnesium may be helpful with constipation
• Calcium chews contain Vitamin K- ** Caution
in patients taking Coumadin
Why is Vitamin D so Important?
• Vitamin D is essential for adequate
gastrointestinal absorption of calcium.
• Insufficient amounts of vitamin D over time
reduces serum calcium levels and can trigger a
compensatory release of parathyroid
hormone.
– This may produce secondary hyperparathyroidism,
resulting in mobilization of calcium from the bone
and a reduction in bone mineral density.
What is the Best Level to Check for
Vitamin D Status?
• 25-OH Vitamin D level is best
• 1,25 OH2 Vitamin D levels are useful in
chronic kidney disease, primary
hyperparathyroidism, sarcoidosis, oncogenic
osteomalacia, vitamin D-resistant rickets,
pseudo- vitamin D deficiency rickets, and
hypophosphatemic rickets
What Do the Results Mean?
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<10ng/mL Severe Vitamin D Deficiency
10-19ng/mL Vitamin D Deficiency
20-29ng/mL Vitamin D Insufficiency
30ng/mL Normal
40-60ng/mL Target range for someone with
history of Osteoporosis with or without
fracture
Health Risk Associated with Vitamin D
Deficiency
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Ricketts
Osteomalacia
Precipitates & exacerbates Osteoporosis
Increased risk of: deadly cancers, cardiovascular
disease, Multiple Sclerosis, Rheumatoid Arthritis,
& Type I DM
• Can also cause muscle weakness & increased risk
for falls
Sources of Vitamin D
• Sunlight
• Food
• Supplements & Medications
• NOF recommendations:
– Adults < 50 years old: 400-800IU/day
– Adults >/= 50 years old: 800-1,000IU/day
Sunlight
• Solar ultraviolet B photons are absorbed by 7dehydrocholesterol in the skin, leading to its
transformation to previtamin D3, which is rapidly
converted to vitamin D3.
– Season, latitude, time of day, pigmentation, aging,
sunscreen use (even SPF of 8 reduces preduction by 95%),
& glass all influence the cutaneous production of vitamin
D3.
• People with fairer skin make more Vitamin D than people with
darker skin.
• Once formed, vitamin D3 is metabolized in the liver to
25-hydroxyvitamin D3 and then in the kidney to its
biologically active form, 1,25-dihydroxyvitamin D3.
Food Sources of Vitamin D
• It is extremely difficult to get all the Vitamin D
you need from diet alone.
• Foods high in Vitamin D: fatty fish (i.e.
mackerel, salmon, tuna, eel), egg yolks, & liver
• Vitamin D is added to the following foods:
milk, some brands of orange juice, soymilk &
cereals
– There is no Vitamin D in other dairy
products like cheese, yogurt, or butter.
Cholecalciferol (Vitamin D3)
• Fat soluble; made from irradiation of 7dehydrocholesterol from lanolin & the chemical
conversion of cholesterol.
• Cholecalciferol 50,000IU is available from at least
1 manufacturer, it is often challenging to find in
retail outlets.
– Mean time to peak= 14 days
• Also, these metabolites have a superior affinity
for vitamin D-binding proteins in plasma, relative
to ergocalciferol.
Ergocalciferol (Vitamin D2)
• Made from ultraviolet irradiation of ergosterol in yeast.
• Clinical studies indicate that vitamin D2 is much less
potent & has a shorter duration of action than
cholecalciferol.
• Ergocalciferol has been used historically to treat
Vitamin D deficiency out of convention, or perhaps
because high-dose ergocalciferol is more widely
available in doses up to 50,000IU per softgel capsule
from multiple manufacturers.
– In patients with severe deficiency, it is often difficult to
raise 25-hydroxy vitamin D levels with ergocalciferol.
– Is 30% less potent than vitamin D3 & has markedly shorter
duration of action
• Mean time to peak= 3 days
Populations at Risk for Low Vitamin D
• People who spend little time in the sun
– Sunscreen, clothing, hats, shade
• People with very dark skin
• Elderly people
• People living in nursing homes or other
institutions
• People with certain medical conditions such as
serious diseases of the nervous system or
digestive systems
• People who are obese
Osteoporosis Treatment
• Osteoporosis medications can be classified
into two main categories:
– Antiresorptives~ slow down bone destruction
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Bisphosphonates
Calcitonins
Estrogen agonists/antagonists
Estrogen therapy (ET) & hormone therapy (HT)
Receptor activator of nuclear factor
KappaB ligand (RANKL) inhibitor
– Anabolics~ bone-building medication
• Parathyroid hormone
A Little Pathophysiology…
• Bone resorption by
Osteoclasts
– Cells release an acid which
dissolve collagen & the
mineral coating of the
bone
• Bone formation by
Osteoblasts
– Cells that lay down new
collagen to aide in
formation of new bone
tissue
Antiresorptives
• Most drug therapies work by decreasing the
reabsorption of bone. At any given time there
is bone that has been reabsorbed but not
replaced & this accounts for 5-10% of bone
mass.
• By decreasing reabsorption of bone, a gain in
bone density of 5-10% is possible, taking
about 2-3 years. However, no drug therapy
will restore bone mass to normal.
Bisphosphonates
• Most commonly prescribed non-estrogen
therapy; acts as an inhibitor of osteoclastic
activity.
• May be beneficial in women who cannot tolerate
ET.
• They are effective in inhibiting bone loss after
menopause, since they slow down bone turnover.
• Unfortunately, this is also what puts these patients at risk for
Atypical Femur Fracture (AFF)
Bisphosphonate Options
• Alendronate (Fosamax)
• Ibandronate (Boniva)
• Risedronate (Actonel)
– The 3 oral agents above must be taken on an empty
stomach, 1st thing in the morning with no other
medications. You must take with a full 8oz glass of
water and remain upright for at least 30 minutes after
swallowing pill.
• Risedronate (Atelvia)
• Zolendronic Acid (Reclast)
Alendronate (Fosamax)
• Dosing: 70mg weekly (osteoporosis men &
women tx), 5mg daily (steroid-induced osteoporosis),
35mg weekly (osteoporosis prevention)
– Is available in a liquid 70mg/75mls weekly
• FDA approved for: 1) the prevention and treatment of
Osteoporosis in postmenopausal women and men & 2)
treating steroid-induced osteoporosis in men and
women.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: Joint, bone or muscle pain. Nausea,
reflux, gastritis, or dysphagia. Hypocalcemia, Atrial
Fibrillation, AFF, & ONJ.
• Renal dosing: CrCl <35; avoid use
Fosamax Plus D
• Dosing: 70mg/2800IU cholecalciferol,
70mg/5600IU cholecalciferol 1 tablet weekly for
the treatment of osteoporosis in men or
postmenopausal women.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: Joint, bone or muscle pain. Nausea,
reflux, gastritis, or dysphagia. Hypocalcemia,
Atrial Fibrillation, AFF, & ONJ.
• Renal dosing: CrCl <35; avoid use
Ibandronate (Boniva)
• Dosing: 150mg pill monthly, 3mg IV every 3
months
• FDA approved for preventing and treating
Osteoporosis in postmenopausal women only
• Fracture prevention: Spine only
• Possible s/e: Joint, bone or muscle pain. Nausea,
reflux, gastritis, or dysphagia. Hypocalcemia,
Atrial Fibrillation, AFF, & ONJ.
• After IV infusion flu-like symptoms, fever &
headaches.
• Renal dosing: CrCl <30; avoid use (po),
contraindicated (IV)
Risedronate (Actonel)
• Dosing: 35mg weekly (male & postmenopausal
osteoporosis), 5mg daily (steroid-induced osteoporosis)
• FDA approved for: 1) the prevention and treatment of
Osteoporosis in postmenopausal women and men & 2)
treating steroid-induced osteoporosis in men and
women.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: Joint, bone or muscle pain. Nausea,
reflux, gastritis, or dysphagia. Hypocalcemia, Atrial
Fibrillation, AFF, & ONJ.
• Renal dosing: CrCl <30; avoid use
Risedronate (Atelvia)
• Dosing: 35mg DR weekly **Give with 8oz of
water AFTER breakfast, remain upright x 30 min.
• FDA approved for preventing and treating
Osteoporosis in postmenopausal women and
men.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: Joint, bone or muscle pain.
Hypocalcemia, Atrial Fibrillation, AFF, & ONJ.
• Renal dosing: CrCl <30; avoid use
Zolendronic Acid (Reclast)
• Dosing: 5mg IV every 12 or 24 months
• FDA approved for preventing (24 mo) and treating (12 mo)
osteoporosis in postmenopausal women and men. Treating
steroid-induced osteoporosis in women and men.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: Joint, bone or muscle pain. Nausea, reflux,
gastritis, or dysphagia. Hypocalcemia, Atrial Fibrillation,
AFF, & ONJ.
• Renal Dosing: CrCl <35; or acute renal impairment
contraindicated
• Tip: If your patient has never been on prior
bisphosphonate therapy, they will likely experience flu-like
chills & body aches up to 48-72 hours after their first two
infusions. This can easily be treated by taking Tylenol
650mg po every 4-6hrs ATC.
Denosumab (Prolia)
• Receptor activator of nuclear factor-KappaB ligand inhibitor
(RANKL)
• Dosing: 60mg/ml SC every 6 months
– Nurse can inject in abdomen, thighs or upper arms
• FDA approved: Treating osteoporosis in postmenopausal
women and men at high risk of fracture.
• Fracture prevention: Spine, hip & other bones
• Possible s/e: May increase risk of infection, rash,
hyperlipidemia , AFF & ONJ
• Renal dosing: None; a great consideration for your patient
with CRI or CKD, who is not on HD/PD.
Prolia Injection Sites
Other Prolia Tips
• Depending on the patient’s insurance, you may choose for
them to bring their own medication from their pharmacy,
go to an infusion center, or do a “buy & bill” from your
office.
• Medication should be kept refrigerated, however once
removed from the fridge it must be administered or
discarded within 2 weeks
– Must be out of the fridge a minimum of 30 minutes before
administration.
• Use of a specialty pharmacy will make the prior
authorization process much easier
• Still takes about a month & numerous faxes/phone calls
• Cost= $856-1026.09 per injection
Osteonecrosis of the Jaw (ONJ)
• A confirmed case is defined as an area of
exposed bone in the maxillofacial region that
does not heal within 8 weeks after
identification by a health care provider, in a
patient who is currently receiving or has been
exposed to a bisphosphonate, and has not had
radiation therapy to the craniofacial region.
ONJ in Osteoporosis Patients
• Prevalence of ONJ in oral bisphosphonate users 0.10%
• Frequency of ONJ~ 0.01-0.04% of oral bisphosphonate
users, if extraction 0.09-0.34%
• 60% of ONJ cases have a preceding history of tooth
extraction, but only 0.5% of extractions result in ONJ
• ONJ has also been reported in patients taking Prolia
(Denosumab)
• Studies have shown that adequate Vitamin D levels
may be associated with improved peridontal health &
critical for post-surgical oral wound healing.
Why the Jaw?
• Thin mucosa overlying osseous tissue
• Frequent site of microbial colonization and
infection
• Common site of surgical intervention or
trauma
• Does the bone turnover differ than other
skeletal sites?
ONJ Prevention
• Good oral hygiene- brush teeth BID & floss
• Inspect teeth & gums daily & look for sore spots/open
areas
• Notify your dentist that you started treatment
(bisphosphonates or Prolia)
• Routine dental cleanings
• Avoid dental procedures while on above medications
• Wear properly fitting dentures
• Smoking cessation
• Notify prescriber of non-healing ulcers
Atypical Femur Fracture (AFF)
• 73 y.o. caucasian female w/ history of
Osteoporosis on Boniva for nearly 5 years with
a previous ankle fx. Presented to ED on
3/16/14 s/p trip & fall over a cord in her
bedroom, when she was filling up her water
bed. She tripped, fell forward and landed on
her knees. The patient immediately felt
excruciating pain and her husband called 911.
Initial X-ray
• Reveals a L subtrochanteric
fracture
• Patient admits to having
“constant cramps” in her L
upper thigh 2 weeks prior to
her fall, causing her to require
a cane for ambulation
• Chance of a AFF 0.05% with
bisphosphonate use.
Surgical Repair of AFF
Drug Holiday
• Duration of treatment should be based on:
– Patient’s risk of fracture
– Pharmacokinetics of the agent prescribed
– Patient preference (shared decision-making)
• At the 5-year treatment period, reassess the need for
continuing treatment based on fracture history, BMD and
clinical risk factors
– For those at low or moderate risk, stopping therapy is a
possibility
– For those at higher risk, consider continuing therapy, consider
drug holiday, or consider alternative medication during drug
holiday
• Ending drug holiday
– Consider fractures, BMD, biochemical markers, FRAX
CCHS CPG “Medication Follow-up”
• For bisphosphonate therapy
Calcitonin (Miacalcin)
• Amino acid peptide hormone that inhibits bone resorption by
osteoclasts, inhibits uptake of calcium from the intestines, &
inhibits resorption of calcium from the kidneys
– Drug first approved in 1975 for the treatment of Paget’s Disease
• Dosing: Nasal spray 200IU/spray in one nostril QD or 100IU IM/SC
injection QOD-QD
• FDA approved for treating osteoporosis in women who are at least
5 years past menopause.
• Fracture prevention: Spine only
– Sometimes used to help with the pain associated with hip fractures in
the acute post-operative period.
• Possible s/e: Injectable form~ nausea, skin rash, frequent urination,
& warmness. Nasal spray~ Runny or irritated nose, headache &
backache. Also, recent studies have shown association w/
malignancy, so CCHS will be removing from formulary.
• Renal dosing: None
Calcitonin vs. Placebo
• ~1% improvement in the BMD of the spine &
most studies show the the results in the hip and
wrist are the same as placebo or slightly better.
• 0.7%
• Cost= $52.85 per bottle of nasal spray
Raloxifene (Evista)
• Classification: Estrogen agonist/Antagonist
– An oral selective estrogen receptor modulator (SERM) that
has estrogenic actions on bone and anti-estrogenic actions
on the uterus & breast
• Dosing: 60mg pill daily
• FDA approved for preventing and treating osteoporosis
in postmenopausal women only.
• Fracture prevention: Spine only
• Possible s/e: Hot flashes, leg cramps, edema, &
DVT/PEs.
• Renal dosing: None
Estrogen Therapy
• Estrogen has a protective effect on the bones prior to menopause,
which is why a woman’s risk increases after menopause & women
that have premature menopause are at increased risk.
– Estrogen reduces bone resorption & increases bone formation
• Dosing: varies depending on drug; pill and patch forms
– Climara, Estrace, Estraderm, Estratab, Ogen, Ortho-Est, Premarin, Vivelle
• FDA approved for preventing osteoporosis in postmenopausal women
• Fracture prevention: Spine, hip & other bones
• Possible s/e: May increase risk of DVT/PE, CVA, MI, breast & ovarian
cancer. Vaginal bleeding, breast tenderness, mood changes, &
gallbladder disease
• Renal dosing: None
• Hepatic Dosing: Contraindicated
Hormone Therapy
• Women past menopause with accelerated bone loss may benefit
from hormonal therapy using estrogen with progesterone. The
estrogen retards bone resorption and thus diminishes bone loss.
• This effect is the most prominent in the first years after menopause,
while risks from HRT increase.
• Dosing: varies depending on drug; pill and patch forms
– Activella, Femhrt, Ortho-Prefast, Premphase, Prempro
• FDA approved for preventing osteoporosis in postmenopausal
women
• Fracture prevention: Spine, hip & other bones
• Possible s/e: May increase risk of DVT/PE, CVA, MI, breast & ovarian
cancer. Vaginal bleeding, breast tenderness, mood changes, &
gallbladder disease.
• Renal dosing: None
• Hepatic Dosing: Impairment/Disease; Contraindicated
Teriparatide (Forteo)
• Parathyroid Hormone
• Dosing: 20mcg SC daily for up to 2 years
– Can self-inject in abdomen or thighs
• FDA approved for treating osteoporosis in postmenopausal men
and women at high risk of fracture
• Fracture prevention: Spine and other bones
• Possible s/e: Nausea, dizziness & cramps
• Renal dosing: None
• Contraindications: Paget’s Disease (unexplained elev. ALP), young
patients with open epiphyses, prior external beam or implant
radiation involving the skeleton, & patient’s w/ current or h/o bone
malignancies/metastases
• Monitoring considerations: After 4 months of therapy, repeat
serum Ca, albumin & Vit D 25-OH levels. Do not check a iPTH it will
be elevated & do not repeat a DXA in 1 year, wait at least 18
months.
Forteo Pen
Forteo Black Box Warning
Forteo
• Insurance approval will require patient to have a prior fragility
fracture or have a t-score of </= -2.5 (Osteoporosis).
• Use of a specialty pharmacy will make the prior authorization
process much easier
•
Still takes about a month & numerous faxes/phone calls
• Your Forteo sales representative will gladly put you in touch with an
educator who works for Lilly, but will (at no cost to you) meet with
your patient at a location and time of your choosing, and talk to
your patient one on one about Forteo & teach them how to inject.
The patient does not need to even be 100% sold on the drug yet.
• Medication must be kept refrigerated at all times.
• Lilly also distributes cooler pack/travel kits to patient starting on
Forteo for travel.
• Cost= $1,507.09 per pen; 1 pen lasts 28 days (does not include
needles)
Please remember…..
• Osteoporosis is a chronic, but treatable
disease & fragility fractures are preventable.
Questions
• Please feel free to contact me:
– [email protected]
– (302)733-5594