WHO OWNS THE BONES?

“Patchwork Quilt” of Women’s Health

Who screens?
Who treats?
Who teaches/ to whom?
Whose job it it?
Rheumatology
Endocrinology
Primary Care
Gynecology
Gerontology
Orthopedics
Organizations
NOF
NAMS
ISCD
 Overview
Prevention and Treatment of Osteoporosis
Demographics
Screening
Prevention/Lifestyle
Risk Factors
Pharmaceuticals
Nutriceuticals
 Definition
Osteoporosis is a skeletal disorder
characterized by compromised bone
strength predisposing to an increased
fracture risk.

BONE DENSITY=BONE DENSITY (70%) + BONE STRENGTH (30%)

BONE DENSITY: grams of mineral per area

BONE QUALITY: architecture, turnover, damage accumulation,
and mineralization

NIH Consensus Development

Conference on Osteoporosis, 2000
 Demographics

10 Million People have Osteoporosis

34 Million People have Osteopenia
1:2 Women will have an osteoporotic
fracture in their lifetime
1.5 Million Fractures Annually
– 20% die within one year
$18B Annually
www.nof.org
 Screening
DEXA is most cost-effective screen today
– All women at least 65 yo
– Perimenopausal, if risk factors
– Any adult > 50 yo with a fracture
– Adults with a condition or on a medication associated
with bone loss
– Patients considering or currently on a medication for
osteoporosis
– Postmenopausal women considering discontinuation
of HRT

NOF Clinicians Guide to Prevention and

Treatment of Osteoporosis
Unrecognized Vertebral Fractures
in Hospitalized Patients
50
45
40
35
30
25
20
15
10
5
0
Fx In Report In In On Rx
Present DCSum Record
Undertreatment of Hip Fracture in
Hospitalized Patients
40
35
30
25 Hosp A
20 Hosp B
Hosp C
15
Hosp D
10
5
0
DXA Ca + Vit D Rx BP Rx
 Densitometry
How often?
– Not more than every 2 years
Which bones?
– Spine, Hip, Femoral Neck
When to treat?
– Osteoporosis
– Osteopenia with another risk factor
Lifestyle
– Exercise, Calcium, Vitamin D, Smoking, Alcohol
Risk Factors
– Age, activity, diet, meds (steroids>3 months), stability, previous
fracture, BMI<21,hip fx in a parent, current smoking
 Bone Densitometry Values

T Score: Standard Deviation comparison of a patient’s

bone density to a normal 25 yo.
We now have comparison tables by sex and ethnic group.
Normal
– T score >-1.0
Osteoporosis
– T score < -2.5
“Osteopenia”
– T score -1.0 to -2.5
 National Osteoporosis Risk
Assessment (NORA)

Bone Density RR 95% CI

Normal BMD 1

Osteopenia 1.8 1.49-2.18

Osteoporosis 4.03 3.59-4.53

 FRAX SCORE
WHO Fracture Risk Assessment Tool

Uses calculations based on patient data to

determine a 10-year risk of hip and major
osteoporosis-related fracture

http://www.shef.ac.uk/FRAX/index.htm
 NAMS Recommendations
Use lowest T-score to define diagnosis
Prevention and nutritional measures first
Drug Treatment:
Any Vertebral Fracture
All T-scores < -2.5
Anyone on steroids >3 months
T-scores of -2 to -2.5 if one risk factor
BMI<21
Fragility Fracture History
Hip Fracture History in a Parent
 Medical Workup
25-OH Vitamin D Levels
FSH
TSH
Parathyroid Hormone
Creatinine Clearance
Alkaline Phosphatase
Liver Enzymes
Celiac Antibodies
Protein Electrophoresis
24-hr. Urine
– Calcium, Creatine, Sodium, Free Cortisol
 Risk Factors used in FRAX
Geographic Region Steroid Use (5 mg/da
Race for over 3 months)
Sex Rheumatoid Arthritis
Height/Weight Secondary
Previous Fragility Osteoporosis
Fracture Alcohol (3 or more
Family History of units daily)
Osteoporosis BMD (T score at
Current Smoking femoral neck)
 So Whom Do We Treat?
Patients with previous hip or vertebral
fracture
T score of -2.5 or less at femoral neck,
total hip, or spine
T score of -1.0 to -2.5 (Osteopenia) AND:
– Other prior fracture
– Secondary cause associated with high fracture risk
– FRAX risk of 3% or more at hip
– FRAX risk of 20% or more for major osteoporosis
related fracture at any site
 Trends in Treatment
Recommendations
2003
Patients with previous hip
or vertebral fracture
T-score of -2 at hip
T-score of -1.5 to -2 at hip
PLUS additional risk
factor.
2008
Patients with previous hip
or vertebral fracture
T-score of -2.5 at femoral
neck, total hip, or spine
T-score of -1 to -2.5 at
femoral neck, total hip, or
spine AND:
– Other fracture
– Other risk factors
– FRAX of 3% or more at hip
– FRAX of 20% for other site
 Treatment Options
Nutrition and Supplements
Exercise
Fall Prevention
Alcohol and Nicotine Avoidance
Pharmaceuticals
– Bisphosphanates
– SERMs
– PTH
– HRT
– Calcitonin
 Bisphosphanates

Generic Brand Name

Alendronate Fosamax
Risendronate Actonel
Ibandronate Boniva
Zoledronic Acid Reclast
Pamidronate Aredia
Etidronate Didronel
Tiludronate Skelid
 Bisphosphanates
Prevention Treatment Comments
Alendronate 5 mg/da 10 mg/da Must take on empty
(Fosamax) 35 mg/wk 70 mg/wk stomach, early am,
with 8 oz. water, no
food for 30 min.
Risendronate 5 mg/da 5 mg/da Same directions as
(Actonel) 35 mg/wk 35 mg/wk for Alendronate
75 mg 2 days/wk 75 mg 2 days/wk
150 mg/mo 150 mg/mo
Ibandronate 2.5 mg/da Same directions as
(Boniva) 150 mg/mo for Alendronate, but
3mg/3mo IVP no food for 1hr.
Check creatinine
before injection.
Zoledronic Acid 5 mg. annually IVP Acute phase
(Reclast) reaction – muscle
aches
Some concern for
atrial fibrillation
 Bisphosphanates
All are indicated for prevention and/or
treatment of postmenopausal osteoporosis
Bind permanently to bone to decrease
osteoclastic activity and increase bone
mass
Concerns about bone quality (“frozen”
bone)
Implications for fertility – contraindicated in
women planning pregnancy
 Bisphosphanates
Similar efficacy
Adverse effects: Esophageal erosion,
hypocalcemia, bone pain
Contraindications: esophageal dysmotility,
significant renal dysfunction, hypocalcemia
Osteonecrosis of Jaw (ONJ):
<1 case/100,000 years of exposure. Usually
with high IV doses for cancer Rx.
Khann. J.Rheumatol.
2009;Mar;36(3):478-90.
 Estrogen Agonist/Antagonist
(Formerly called SERMS)
Raloxifene (Evista)
• Bind to ER, activating some/ blocking
others
• Decrease vertebral fractures, but no
significant effect on hip fractures
• One 60 mg tab daily
• Adverse Effects: hot flashes, VTE, leg
cramps
Ettinger et al. JAMA 1999;282:637-645.
Pharmacologic Treatment Options
Anabolics
– Teriparatide (Forteo)
Antiresorptives
– Calcitonin
– Estrogens
– SERMS (Raloxifene/Evista)
– Bisphosphanates
Alendronate
Risendronate
Ibandronate
Zoledronic Acid
Recombinant Parathyroid Hormone
(r-PTH:Teriparatide (Forteo)
Stimulates new bone formation
New fractures are significantly decreased
– Vertebral decreased by 65%
– Non vertebral decreased by 55%
Concern about malignancies in mice
Dosage
– 20 mcg SQ daily for 2 years
Cost - $20. per day
Neer, RM, et al. NEJM 2001;344:1434-
41
Calcitonin (Miacalcin, Fortical)
Naturally occuring hormone which
antagonizes the effects of PTH
Reduces osteoclastic bone resorption
200 IU intranasal spray achieves 33%
reduction in vertebral fractures in
postmenopausal women with prior
vertebral fractures (PROOF study)

Chestnut et al. Am J. Med.

2000;109:267-276.
 Compliance FACT
After being prescribed a pharmaceutical for
osteoporosis or osteopenia, less than 50%
of patients have continued therapy at 6 mo
Cost issues
Side effect issues
“Silent Disease” issues
How can we affect this statistic???
 Lifestyle Issues

Exercise
Calcium
Vitamin D
Medications
Poor Consumption of Vitamin D
NHANES III DATA

National Health and Nutrition Evaluation

Survey
J.Amer Diet Assn. 2004:104:980-983
 Bone Health
Calcium:
35 RCTs document that calcium prevents or
reduces bone loss in adults
Dose
– Premenopausal (or on HRT): 1000 mg daily
– Postmenopausal: 1500 mg daily
Vitamin D:
Oral Vitamin D between 700-800 IU/d
significantly reduces the risk of fractures
400 IU/d is not sufficient for prevention
Working Smarter, not Harder
Shared Medical
Appointments (SMA)
Basics
– Number served
– Confidentiality statement
– Charges (99214)
25-40’. 50% Counseling
Dexa SMA
– Data reviewed and
distributed
– Diagnoses established
– Lifestyle measures
– Therapies discussed
FINISH

Thank you
 Prescription Nutritionals
3 Primary Concerns for Women’s Health:
Bone Health
Cardiovascular Health
Mental Well-Being
Primary Nutrients with Supporting Evidence:
Calcium
Vitamin D
Omega-3 Fatty Acids
Folic Acid
Vitamin B 6
 Cardiovascular Health
Omega-3 Fatty Acids:
Eskimo observational studies
Nurses Health Study
Physician’s Health Study
– RR 0.77 decreased mortality
– 850 mg can be expected to save 20 lives per 1000 patients with CHD over 3.5 yrs.
Folic Acid
Lowers homocysteine
Improves endothelial function
B Vitamins
Nurses Health Study
– RR 0.55 of MI in groups with highest levels of Folate and B 6
SHEEP Study
– RR 0.66 of MI in women taking B vitamin supplements
Calcium
Significantly increases HDL:LDL Ratio
Suggests 30% reduction in CV events
 Mental Well-Being
Omega-3 Fatty Acids
Reverses inflammation from Omega-6 and
dysmenorrhea
Significant reduction in menstrual symptoms in
adolescents
Calcium
48% fewer PMS symptoms than placebo group
Osteoporosis risk much greater in women with history of
PMS
Folic Acid
Low folate has been linked to depression
Depressed patients have increased homocysteine levels
 Prescribing Nutriceuticals
Write out above recommendations and send
the patient to a pharmacy, healthfood
store, Nutritionist, or Sams Club,
Or . . . .
Prescribe Nutriceuticals
ENCORA
METAGENICS
 Ideal Dosing of Nutritional
Supplements for Women
Calcium
1200 mg for women >51 (IOM)
Doses >500 mg should be divided
Better utilized if larger dose is at HS
Vitamin D
400 IU (IOM) wrong
New evidence suggests 700-800 IU
Needed to absorb calcium and prevent hyperparathyroidism
Omega-3 Fatty Acids
500/d in those at risk for CHD
1000 mg/d if documented CHD (AHA)
Folic Acid
400 mcg/d (IOM)
0.8-5 mg being studied for CV benefit
Larger dose in AM (prime time for MI)