osteoporosis: pathophysiology and management dr. frank
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Osteoporosis: Pathophysiology and ManagementDr. Frank Waldron-Lynch M.D Ph D MRCPI MRCP(UK),
Section of Endocrinology, Yale University School of Medicine.
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Outline
• Definition of osteoporosis• Pathogenesis• Diagnosis• Therapy• Future development
http://www.med.yale.edu/intmed/endocrin/patient/bonecenter.html
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Classic presentation
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Definition
• Clinical– Loss of bone mass sufficient to significantly
increase the risk of fracture
• Diagnostic– T score – number of standard deviations above or
below the mean for a similar healthy 30 year old• Normal BMD = T: 0 to -1• Osteopenia BMD = T: -1 to -2.5• Osteoporosis BMD = T: less than -2.5
– Z score – number of standard deviations above or below the mean for the patients age, sex and ethnicity
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Epidemiology
• United States– 10 million individuals with osteoporosis– 34 million individuals with osteopenia
• Fracture Risks over age 50– 50% of women will have an osteoporosis related
fracture– 25 % of men will have an osteoporosis related
fracture
• Estimated costs– Direct health care $14 billion each year
http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/default.asp
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Pathogenesis
• Peak bone mass
• Etiology Bone loss
• Age
• Secondary causes
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Peak Bone Mass
• Genetically determined– 70-75%– Driven by sex hormones during puberty– Depends on site measured – spine, femur, radius
• Ethnicity– Chinese American later than Caucasians
• Women– Peak accrual ages 11-15– 95 per cent achieved by late teens
• Men– Peak accrual later teens– Maximum spine age 20– Radius and femur by mid twenties
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Factors Affecting Peak Bone Mass
• Delay or Failure of puberty– Primary Hypogonadism
• Turners syndrome• Klinefelter syndrome• Absent cervix, uterus, cervix and/or vagina • Cryptorchidism • Chemotherapy, Radiotherapy• Chronic systemic diseases
– Secondary Hypogonadism• Kallmann syndrome• CNS tumors, infiltrative disorders• Malnutrition • Chronic systemic illness
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Etiology of Bone loss in Osteoporosis
OSTEOCLAST - RESORPTIONOSTEOBLAST - FORMATION
Primary cause is estrogen deficiency+
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Estrogen Deficiency
• Women – Occurs earlier– At menopause bone loss rates to increase by 2
to 6 fold– For subsequent 6-8 years– Impairs calcium absorption from gut
• Men– Testosterone declines age– Estrogen declines age– Both androgens and estrogen contribute
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Riggs B. N Engl J Med 1986;314:1676 Age (years)
Ann
ual F
ract
ure
Inci
denc
e,
per 1
00,0
00
0
1000
2000
3000
4000
35 45 55 65 75 85+
Vertebrae
Hip
Colles'
Fracture Risk with Aging
Caucasian women
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Hip Fracture Risk for a Given T-score Depends on Age
10 year risk of fracture in Swedish women
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Secondary causes of accelerated bone loss• Inherited disorders
– Osteogenesis imperfecta tarda– Thallasemia
• Amenorrhea – Eating disorders– Low weight– Excess Exercise– Female athlete triad
• Energy deficiency• Low bone mineral density• Amenorrhea
– Premature ovarian failure
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Secondary causes of accelerated bone loss• Respiratory
– Cystic fibrosis• Gastrointestinal
– Celiac sprue– Post Gastric by pass– Inflammatory bowel disease
• Renal– Idiopathic hypercalciuria– Chronic renal failure
• Post organ transplant– Immunosuppressive therapy
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Secondary causes of accelerated bone loss• Endocrine
– Hyperthyroidism– Hyperparathyroidism– Cushing’s syndrome– Hypogonadism– Vitamin D deficiency
• Rheumatology– Rheumatoid arthritis– Seronegative athropathies
• Lifestyle– Smoking– Alcohol
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Secondary causes of accelerated bone loss• Drugs
– Glucocorticoids– Cyclosporine– Anti seizure medications
• Phenobarbital• Phenytoin
– Heparin– Chemotherapy
• Aromatase inhibitors
– Thyroxine• Over replacement
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Diagnosis
• Approach to patient
• Investigations– Bloods– Urine– Imaging
• FRAX use
• Calcium and Vitamin D
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Approach to patient with suspected osteoporosis – guide investigations• Focused history
– Fracture history– Loss of height– Exercise– Menstrual history– Hypogonadism men– Diet– Smoking– Alcohol
• Past medical history– Secondary causes
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Focused history
• Medications– Any drugs effect BMD– Any drug affect calcium absorption
• Family history– History osteoporosis
• Systems review– Gastrointestinal system
• GERD• Esophageal stricture• Malabsorption
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Examination – Key points
• Weight– Calculate body mass index
• Height– Measure and follow– Loss greater than 1 inch may indicate spinal
fracture• Muscular skeletal
– Spine• Deformity• Tenderness• Mobility
– Muscle strength• Proximal muscle weakness
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Investigations
• Bloods -Basic– CBC– Electrolytes and eGFR– Serum calcium and phosphate– TSH– Testosterone (Men)– Serum protein electrophoresis – Bone markers (consider)
• Urine– 24 hour urine– Volume– Creatinine and calcium
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OSTEOCLAST - RESORPTIONOSTEOBLAST - FORMATION
Intact Osteocalcin (OCI) Mineralization
Bone Alkaline phosphatase (Bone AP) MaturationDeoxypyridinoline (fDPD/Cr)
N-Terminal cross-linking telopeptide
(NTx/Cr)
Procollagen Type 1N Propeptide (PINP) Synthesis
Bone re modelling – Bone markers
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Bone markers - Use
• Diagnosis– Identification high bone turnover states– Not as well validated as DXA
• Monitor therapy– Commencing– During treatment– Urinary Ntx
• Should decrease on bisphosphates
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Direct measurement of BMD by DXA and as well as CT allows us to diagnose osteopenia
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• Bone mineral density testing – Important means of assessing fracture risk– Not stand alone test
• Other risk factors have impact on fracture risk – occasionally more significant impact than bone
density results alone– Glucorticoids
• All known risk factors should be considered when deciding to treat patients– Mostly treating patients based on risk– No overt disease
• We need better tools for assessing fracture risk
Bone mineral density testing
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FRAX - Fracture Risk Assessment Tool
WHO has recently released FRAX, the WHO Fracture Risk Assessment Tool. Patients and clinicians can access this tool at:
http://www.shef.ac.uk/FRAXhttp://www.shef.ac.uk/FRAX
– Data from 9 cohorts around the world– Validated in 11 independent cohorts with similar
geographic distribution
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FRAX - Use
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FRAX variables
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Treatment recommended
• Consider FDA-approved medical therapies in postmenopausal women and men aged 50 years and older, based on the following:– A hip or vertebral fracture – T-score ≤ -2.5 at the femoral neck or spine after
appropriate evaluation to exclude secondary causes
– Low bone mass (T-score between -1.0 and -2.5 at the femoral neck or spine) and a 10-year probability of a hip fracture ≥ 3% or a 10-year probability of a major osteoporosis-related fracture ≥ 20%
– Clinicians judgment and/or patient preferences may indicate treatment for people with 10-year fracture probabilities above or below these levels
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Caveats regarding FRAX
• Prospective data on the efficacy of FRAX in making pharmacologic treatment decisions are lacking
– Can osteoporosis medication help equally well with all risk factors? (likely not!)
– That is, not everyone with a high FRAX should be treated with a medication
– We need intervention trials with FRAX as an outcome
• It does not capture spinal osteoporosis
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Non Pharmacologic Treatment
• Essential – Are as important as any medication
• Nutritional– Calcium– Vitamin D– Vitamin A
• Lifestyle– Smoking– Exercise
• Falls risk reduction
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Calcium and Vitamin D
• Calcium– Total sufficient to prevent calcium
malabsorption and secondary hyperprathyroidism
– Test adequate by 24 hour urine if eGFR > 60cc/min
– Total daily intake 1500 mg/day
• Vitamin D– Aim serum 25(OH) vitamin D > 25 ng/dl (ideally
25-35)– Total daily intake 800 IU– Higher if malabsorption
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Effects of Vitamin D supplementation
• Double-blind community-based RCT in the UK
• 2686 individuals (2037 men; 649 women)– Over age 65
• 100,000 U of vitamin D3 orally every 4 months for 5 years
• mailed to the study subjects so compliance not confirmed
Trivedi et al. BMJ;326:469
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Drug Therapy for Low Bone Mass
Prior to drug therapy treat any secondary causes
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Drug Therapy for Low Bone Drug Therapy for Low Bone MassMass
• Bisphosphates
• Parathyroid hormone
• Selective Estrogen Receptor Modulators
• Denosumab
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Targeting the bone resorption side of thebone remodeling cycle
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ETIDRONATEETIDRONATE
PAMIDRONATE
ALENDRONATE
IBANDRONATE
RISEDRONATE
TILUDRONATE
CLODRONATECLODRONATE
ZOLEDRONATE
Bisphosphonates
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Bisphosphonates are the most effective antiresorptive agents available for the
prevention and treatment of bone loss.
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Anti-fracture efficacy of bisphosphonates in osteoporotic women
Vertebralfracture
Hip fracture
Non-vertebral fracture
Alendronate (Fosamax®)
√√ √√ √√
Risedronate (Actonel®)
√√ √√ √√
Zolendronate (Reclast®)
√√ √√ √√
Ibandronate(Boniva®
√√ ?? √√
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When can the patient have a drug holidayfrom bisphosphonates?
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The Flex Trial
1. Time to non vertebral fracture2. Time to vertebral fracture after 5 years
JAMA 296:2927
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Management of patients taking bisphosphates
• Dental examination prior to treatment• Repeat BMD 1-2 years of treatment
– Demonstrate efficacy• Check BMD 1-2 years later
– Improve patient compliance• 5 years
– Stop drug individuals with a good response– No longer osteoporotic
• 10 years– Stable BMD– No recent fractures
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Raloxifene
• Selective Estrogen Receptor Modulators (SERMs)
• Raloxifene– Reduces vertebral fracture– No reduction in hip fracture
• Reserve use with women without hip involvement
• Other beneficial actions– Reduces risk invasive breast cancer– No increase on cardiovascular motality of
mobidity
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Denosumab: therapy targeted atthe RANKL/OPG system
Not approved by FDA yet
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Osteoclast precursorRANKRANK
OPGOPG
RANKRANK -Ligand-Ligand
Osteoblast
DenosumabDenosumab
Humanized anti-RANK-Ligand
Mechanism of action Denosumab
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Denosumab: The FREEDOM trial
• 7,868 women ages 60 to 90• Mean L-spine T-score -2.8• 23% of had prevalent vertebral fractures at
baseline• 60 mg of denosumab subQ every six months or
placebo for 3 years• 68% reduction in vertebral fractures p<0.0001.• 20% reduction in non-vertebral fractures p=0.011.• 40% reduction in hip fracture at p=0.036.• No increased incidence of malignancy • Some increase in erysipelas
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Targeting the bone formation side of thebone remodeling cycle
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Parathyroid Hormone
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PTH - Mechanism of Action
PTH binds to cell surface
G protein-coupled receptor
Decreased apoptosis andstimulation of osteoblasts
Stimulation of differentiationof proosteoblasts to osteoblasts
Net increase in number andaction of bone forming
osteoblasts
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Effect of rhPTH(1-34) on the Risk of New Effect of rhPTH(1-34) on the Risk of New Vertebral FracturesVertebral Fractures
*p <0.001 vs. Placebo
Ris
k R
edu
ctio
n (
RR
)
Placebo(n=448)
rhPTH 20(n=444)
rhPTH 40(n=434)
64 22 19100%
75%
50%
0%
25%
% o
f Wo
men
8
0
246
101214
RR 0.31 (95% CI, 0.19 to 0.50)*
RR 0.35 (95% CI, 0.22 to 0.55)*
65% 69%
No. of women who had > 1 fracture
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PTH plus ALENDRONTE may not be better than PTH alone
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PTH
• Advantages– First anabolic therapy– Good efficacy data
• Use first prior to bisphosphate• 18 months – 2 years treatment
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PTH
• Disadvantages– Must be given by subcutaneous injection– Risk Osteosacroma– Cost
• Monitoring– Hypercalcemia and hypercalciuria– Check one week and then six months after
initiation treatment
• Not use in patients with calcium oxalate renal stone disease
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Summary
• Osteoporosis is an important public health problem
• Accurate diagnosis and treatment requires the use of bone densitometry.
• Radiologists play a central role in the diagnosis and management– of this disease:– measuring bone density– diagnosing fractures– pointing out secondary causes of bone loss
• There needs to be greater attention paid to fall risk-reduction and other modifiable environmental factors.
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Summary
• A variety or antiresorptive agents are available for the prevention and treatment of osteoporosis of which the bisphosphonates are the most efficacious.
• Parathyroid hormone is the 1st truly anabolic therapy for the treatment of osteoporosis and is an important addition to our therapeutic regimen.
• Additional anabolic therapies are on the horizon
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Thank you for your attention