Algorithm for the Management of Osteoporosis.10[1]

8/6/2019 Algorithm for the Management of Osteoporosis.10[1]

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Product Code: SMJ10-10A

CME Topic

Algorithm for the Management of OsteoporosisRonald C. Hamdy, MD, FRCP, FACP , Sanford Baim, MD, FACR,

Susan B. Broy, MD, FACP, FACR, CCD , E. Michael Lewiecki, MD, FACP, FACE,

Sarah L. Morgan, MD, MS, RD, FADA, FACP, CCD, S. Bobo Tanner, MD , and

Howard F. Williamson, MD, FACOG

Abstract: Osteoporosis is a common skeletal disease that weakens

bones and increases the risk of fractures. It affects about one half of

women over the age of 60, and one third of older men. With appropriatecare, osteoporosis can be prevented; and when present, it can be easily

diagnosed and managed. Unfortunately, many patients with osteoporo-

sis are not recognized or treated, even after sustaining a low-trauma

fracture. Even when treatment is initiated, patients may not take med-

ication correctly, regularly, or for a sufficient amount of time to receive

the benefit of fracture risk reduction. Efforts to improve compliance and

treatment outcomes include longer dosing intervals and parenteral ad-

ministration. Clinical practice guidelines for the prevention and treat-

ment of osteoporosis have been developed by the National Osteoporosis

Foundation (NOF) but may not be fully utilized by clinicians who must

deal with numerous healthcare priorities. We present an algorithm to

help streamline the work of busy clinicians so they can efficiently

provide state-of-the-art care to patients with osteoporosis.

Key Words: algorithm, FRAX, osteopenia, osteoporosis, vitamin D

Osteoporosis is a common condition characterized by a re-duced bone mass, altered bone architecture, and increasedfracture risk.

1,2

It affects both genders, and predominantly those

From the of Department of Geriatric Medicine and Gerontology, QuillenCollege of Medicine, East Tennessee State University, Johnson City, TN;Department of Clinical Medicine, Chicago Medical School, Chicago, IL;Department of Medicine, University of Colorado Health Sciences; NewMexico Clinical Research & Osteoporosis Center, Albuquerque, NM,and Department of Medicine, University of New Mexico School of Med-

icine, Albuquerque, NM; Department of Nutrition Sciences and Medi-cine, University of Alabama at Birmingham, Birmingham, AL; Rheu-matology and Allergy Division, Vanderbilt University Medical Center,

Nashville, TN; and Cullman OBGYN PC, Cullman, AL.

Reprint requests to Ronald C. Hamdy, MD, FRCP, FACP, Department ofGeriatric Medicine and Gerontology, Quillen College of Medicine, EastTennessee State University, Box 70429, Johnson City, TN 37614. Email:[email protected]

The views expressed in this article are solely those of the authors and areonly intended for guidance. They do not substitute clinical judgment,which must be tailored to the individual patient and made by healthcare

providers. Neither the Southern Medical Association nor the SouthernMedical Journalendorse or condone statements made in this manuscript.

Dr. Morgan received honoraria as a consultant from Amgen and Eli Lilly,received an honorarium as a consultant/speaker from Genentech, and re-ceived an honorarium for teaching bone density classes from the Interna-tional Society for Clinical Densitometry. Dr. Williamson received honorariaas a speaker from Eli Lilly and Novartis. Dr. Broy received honoraria as aconsultant and speaker for Amgen, Eli Lilly, Novartis, and Warner Chilcott.Dr. Tanner received honoraria as a speaker for Genentech/Roche, Eli Lilly,

Novartis, and Amgen. Dr. Lewiecki received grant and research supportfrom Amgen, Eli Lilly, Novartis, Merck, Warner Chilcott, Genentech, andother support from Amgen, Eli Lilly, Novartis, and Genentech for involve-ment with their respective scientific advisory boards speakers bureaus. Heis on the board of directors, International Society for Clinical Densitometry.Dr. Hamdy has received honoraria as a speaker/consultant for Amgen, EliLilly, Proctor & Gamble, and Novartis.

Accepted June 17, 2010.

Copyright 2010 by The Southern Medical Association

0038-4348/02000/10300-1009

Key Points With appropriate care, osteoporosis can be prevented; and

when present, it can be easily diagnosed and managed.

It is recommended, whenever possible, to test patients

at risk for osteoporosis with DXA measurement of at

least two skeletal sitesusually the lumbar spine and

proximal femur.

The minimum recommended laboratory tests for pa-

tients diagnosed with osteoporosis or osteopenia in-

clude complete blood count, comprehensive metabolicprofile, and serum vitamin D (25-hydroxyvitamin D)

level. Other tests may be appropriate for patients with

special considerations.

Medications are available to manage osteoporosis

and reduce fracture risk, and there are many life-

style changes individuals should use to help man-

age osteoporosis.

Every adult should be advised on the importance of

adequate calcium and vitamin D intake, good nutri-

tion, and healthy lifestyle to enhance skeletal health.

Southern Medical Journal Volume 103, Number 10, October 2010 1009


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over the age of 50 years. It is now easily diagnosed, and a

number of medications are available to significantly reduce the

risk of fractures. The estimated economic impact of osteoporo-

sis-related fractures is staggering: $17 billion was spent in 2005

alone.3 The prevalence of osteoporotic fractures exceeds the

combined prevalence of breast cancer, stroke, heart failure, and

myocardial infarction.4 6

Unlike most of these conditions, how-ever, the prognosis of osteoporosis is good if adequately treated

in a timely manner. Unfortunately, osteoporosis still remains

underdiagnosed and undertreated, even after patients sustain low-

trauma hip fractures.717

It is possible that lack of time rather than lack of interest

is the main cause of the underdiagnosis and undertreatment of

osteoporosis. Also, the availability of multiple guidelines may

hinder rather than help primary care providers, especially as

most of these guidelines are geared towards specialists rather

than generalists and therefore tend to be comprehensive and

all-inclusive. The authors therefore feel there is a need to

consolidate and simplify the available guidelines; and to de-

velop an algorithm that busy primary care clinicians can use

to diagnose and manage osteoporosis (Fig.).

Diagnosing Osteoporosis

The diagnosis of osteoporosis can be established by:

The presence of a fragility fracturea fracture sus-

tained spontaneously, after minimal trauma, or after a

fall from a height not exceeding the body height.

This includes vertebral compression fracture de-

tected by spine imaging such as radiography, or Ver-

tebral Fracture Assessment (VFA) by dual x-ray ab-

sorptiometry.

A T-score of2.5 or less with bone mineral density

(BMD) testing of the proximal femur(s), lumbar

spine, or one-third (33%) radius by DXA, using the

Fig. Osteoporosis Algorithm. VFA, Vertebral Fracture Assessment; DXA, dual energy x-ray absorptiometry test; HRT, hormonereplacement therapy; FRAX, World Health Organization Fracture Risk Assessment Tool; BMD, bone mineral density.

Hamdy et al Algorithm for the Management of Osteoporosis

1010 2010 Southern Medical Association


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guidelines established by the World Health organi-

zation (WHO).

Identifying At-Risk Patients

As osteoporosis is an asymptomatic condition until afracture occurs, bone density testing is recommended in the

following patients:

women aged 65 years and older1821;

men aged 70 years or older18,19;

postmenopausal women or men age 50 years and older

with clinical risk factors for fracture,18,19 including

history of hip fracture in one of the biological parents;

current cigarette smoking; current alcohol abuse, as

defined by 3 or more drinks a day; and a diagnosis of

rheumatoid arthritis;

adults who have sustained a fracture after age 50 years16,19

; chronic glucocorticoid therapy (5 mg/d of prednisone

or equivalent for3 months)16,21,22;

adults with a medical disease or condition that may be

associated with a low bone mineral density (BMD) or

bone loss16,18 (Tables 1 and 2);

adults on medication that may induce bone loss16,18

(Table 3).

Selecting a Bone Density Test

It is recommended, whenever possible, to test patients at

risk for osteoporosis with DXA measurement of at least two

skeletal sitesusually the lumbar spine and proximal femur.When one or both of those skeletal sites cannot be measured

due to structural abnormalities (eg, osteophytes, vertebral

compression fractures, previous surgery involving the lumbar

spine, or previous surgery or severe deformity of the hips) or

other reasons (eg, body weight exceeding DXA table speci-

fications or inability to lie on the DXA table), then the fore-

arm (one-third radius) should be measured.

If the patient reports a height loss of 2 or more from the

maximum historical height, a spine imaging study such as the

VFA is recommended in addition to the BMD measurement

by DXA. The presence of a vertebral compression fracture in

the absence of significant trauma is consistent with a diag-

nosis of osteoporosis and is a significant independent risk

factor for future fractures.19

Table 1. Risk factors for low bone mass/osteoporosis1820

Nonmodifiable Modifiable

Female sex Sedentary

Increased age Low calcium intake

Small body frame SmokingCaucasian race Excess alcohol intake

Positive family history Low body weight (127 pounds)

Postmenopausal status

Previous fractures

Table 2. Diseases that may be associated with areduced bone mass1820

Endocrinal diseases

Cushing disease

Female athlete syndrome

Hyperparathyroidism

Hyperthyroidism

Hypogonadism in men and women

Type 1 and type 2 diabetes mellitus

Gastrointestinal disorders

Celiac disease

Inflammatory bowel disease

Liver diseases

Malabsorption

Primary biliary cirrhosis

Status postgastrectomy or intestinal bypass surgery

Genetic disorders

Ehlers-Danlos syndrome

Gaucher disease

Homocystinuria

Hypophosphatasia

Marfan syndrome

Osteogenesis imperfecta

Inflammatory diseases

Ankylosing spondylitis

Rheumatoid arthritis

Systemic lupus erythematosus

Nutritional disorders

Anorexia nervosa

BulimiaLow lifetime calcium consumption

Female athlete syndrome

Hypovitaminosis D

Hematologic disorders

Hemochromatosis

Hemophilia

Leukemia

Pernicious anemia

Porphyria

Thalassemia

Respiratory diseases

Chronic obstructive pulmonary diseaseNeurologic diseases

Multiple sclerosis

Paretic and Paralytic states

Strokes

Others

Amyloidosis

Renal failure

CME Topic



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Epidemiological studies have shown that peripheral bone

density measurements such as quantitative ultrasound (QUS)

and peripheral DXA of the heel can be used to predict frac-

ture risk.23 However, with the exception of the one-third ra-

dius, peripheral BMD measurements cannot be used for di-

agnostic purposes. It is also not uncommon for patients to

have a normal T-score with QUS of the heel and yet have

osteopenia or osteoporosis with DXA testing of the lumbar

spine and hips. As the age-associated pattern of decrease inBMD is different in different bonesvery slow in the heel and

much more rapid in the lumbar spinethe rate of detection of

osteoporosis or osteopenia would be much lower in patients

having scans of the heel performed and higher in patients

having the lumbar spine analyzed.

There is concern that if non-DXA technologies are used

exclusively in clinical practice, many patients who could ben-

efit from therapy will not be identified. However, if periph-

eral measurements suggest osteoporosis, a central DXA is

indicated, and is likely to be reimbursed by Medicare for the

purposes of establishing baseline scan BMD values that may

be helpful in monitoring the effect of therapy.

24

Understanding DXA Scan Results

BMD measured by DXA is calculated by dividing the

bone mineral content (g) by the surface area (cm2) of the

bones scanned. The patients BMD is then compared to that

of two reference populations:

a young, healthy adult population of the same sex. The

number of standard deviations between the patients

BMD and the mean BMD of this population is referred

to as the T-score.

An age- and sex-matched population. The number of stan-

dard deviations between the patients BMD and the mean

BMD of this population is referred to as the Z-score.

If the lowest T-score of the femoral neck, total hip, or

lumbar vertebrae (or one-third radius, if measured) is 2.5 or

lower, or if there is a past history of fragility fracture, the patienthas osteoporosis. This patient should be investigated for factors

contributing to osteoporosis and considered for treatment to re-

duce fracture risk.18,19

If the lowest T-score is between 1.0 and2.5, and

there is no past history of fragility fracture, the patient has

osteopenia (low bone mass). This patient may benefit from

fracture risk assessment using VFA and FRAX25:

If the VFA shows a vertebral compression fracture and

the patient denies any back trauma, the diagnosis is os-

teoporosis, and treatment should be considered.

The WHO FRAX

estimates the 10-year probability (ex-pressed as a percentage) of major osteoporotic fracture

(spine, hip, proximal humerus, or distal forearm) and

the 10-year probability of hip fracture. At present, the

FRAX, can only be applied to untreated patients. The

NOF has issued guidelines to determine the 10-year

fracture probability at which it is likely to be cost-

effective to treat with a pharmacological agent to re-

duce fracture risk: 20% and above for major osteopo-

rotic fracture or 3% and above for hip fracture.18

Healthy lifestyle and good nutrition are indicated for all

patients, regardless of fracture risk. In addition, efforts to

reduce the frequency of falls or the impact of falls may

reduce the risk of fracture, especially in older people.

If the lowest T-score is 1.0 or higher, the patient has a

normal bone density.

Recommending Laboratory Tests Prior to

Initiating Treatment

The following laboratory tests are the minimum recom-

mended for patients diagnosed with osteoporosis or osteope-

nia in order to identify secondary causes and aid in determin-

ing optimum treatment:

complete blood count, to detect the presence of ane-

mia, macrocytosis or microcytosis;

comprehensive metabolic profile, to assess serum cal-

cium level; renal and hepatic functions; and abnormal-

ities that may be suggestive of malnutrition (low al-

bumin, low total protein, low cholesterol), or multiple

myeloma (elevated serum protein);

serum vitamin D (25-hydroxyvitamin D) level to de-

tect hypovitaminosis D; and

additional tests that may be appropriate for some pa-

tients include: serum parathyroid hormone (intact mol-

Table 3. Medications associated with a low bone mass18,19

Medications associated with a low bone mass

Glucocorticoids

Anticonvulsants (phenytoin, phenobarbital)

Proton pump inhibitorsAromatase inhibitors

Androgen deprivation therapy

Excessive doses of thyroid hormone

Long-term heparin

Gonadotropin-releasing hormone agonists

Progesterone

Cyclosporine

Aluminum-containing antacids

Cytoxic drugs

Exchange resins

Excessive doses of vitamin A

Selective serotonin-reuptake inhibitorsThiazolidinediones




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ecule); tissue transglutaminase or anti-endomysial anti-

bodies; erythrocytic sedimentation rate; serum or urine

protein electrophoresis; serum bone-specific alkaline

phosphatase; serum C-telopeptide (CTX); serum or urine

N-telopeptide (NTX); serum P1NP; thyroid-stimulating

hormone (TSH); serum phosphorus; and 24-hour urinary

calcium, creatinine, sodium, and cortisol.

Treating OsteoporosisThe ultimate decision as to whether to treat and how to

treat a patient should be based on all available clinical infor-mation. Therefore, these guidelines are merely aids in helping

clinicians reach these decisions.

Determining Who Should be Considered for

Treatment

Those who have sustained fragility (low energy or low

trauma) fracture of the hip or spine;

Those who have densitometric evidence of osteoporo-

sis (lowest T-score of2.5 or less at the femoral neck

or lumbar spine) after evaluation for secondary causes

of osteoporosis;

Those who have a densitometric diagnosis of osteope-nia and a FRAX 10-year probability of major osteo-

porotic fracture of 20% or more or 10-year probability

of hip fracture of 3% or more.18

Medications are available to manage osteoporosis and

reduce fracture risk (Table 4). Additionally, there are many

lifestyle changes individuals should use to help manage os-

teoporosis. Some of these include:

adequate calcium and vitamin D intake. The NOF rec-

ommends at least 1,200 mg of calcium and 800 to

1,000 IU of vitamin D daily for adults 50 years of age

and older. Its possible that the recommended mainte-

nance vitamin D dose is too low and may need to be

increased in the future.35

Good nutrition including adequate protein intake

(especially important in the elderly);

smoking cessation;

cessation of alcohol abuse;

resistive and endurance physical exercises;

back extension exercises36

Monitoring OsteoporosisIn order to monitor a patients response to medication

and lifestyle changes, follow-up DXA scans are appropriate.

The timing of the follow-up DXA scan depends on the ex-

pected change in BMD, and the precision and least significant

change (LSC) of the DXA center where the scans are per-

formed. A repeat DXA scan 12 years after treatment is

initiated should be considered. Satisfactory responses to treat-

ment include an increase in BMD exceeding the LSC or a

change in BMD within the LSC bracket. To calculate a tech-

nologists precision, clinicians can utilize the ISCD Advanced

Precision Calculating Tool, available at http://www.iscd.org/visitors/pdfs/EnglishPrecisionCalculatingTool-Advanced.xls.

Changes in the level of bone turnover markers in the

serum or urine may also be used to monitor the patients

response to treatment. When bisphosphonates are adminis-

tered, a reduction of 40% or more in the markers of bone

resorption suggests a positive response. Treatment-induced

changes in bone markers also may be predictive of BMD

response and fracture-risk reduction.37

Noncompliance is common and associated with more

fractures. In a study on bisphosphonate adherence, at 50%

compliance with bisphosphonates, fracture rate was no dif-

Table 4. Fracture risk reductionmedications approved by the FDA for the treatment of osteoporosisa

Medication Study No.Duration

(yr)

VertebralFx risk

reduction

Hip Fxrisk

reduction Formulation Administration

Alendronate FIT26 2,027 3 Yes Yes Oral Daily, weekly

Risedronate VERT27 2,458/1,116 3 Yes Oral Daily, weekly, monthly

HIP28 5,445 3 Yes Oral Daily, weekly, monthly

Ibandronate BONE29 2,946 3 Yes No Oral, Intravenous Monthly (oral), every 3 mo (IV)

Zoledronate HORIZON30 7,736 3 Yes Yes Intravenous Every year

Raloxifene MORE31 7,705 3 Yes No Oral Daily

Calcitonin PROOF32 1,255 5 Yes No Intranasal Daily

Teriparatide33 1,637 1.5 Yes No Subcutaneous Daily (2 yr maximum)

Denosumab FREEDOM34 7,868 3 Yes Yes Subcutaneous Every 6 mo

aFDA, U.S. Food and Drug Administration; FIT, Fracture Intervention Trial; VERT, Vertebral Efficacy with Risedronate Therapy; HIP, Hip InterventionProgram; BONE, Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe; HORIZON, Health Outcomes and Reduced Incidence withZoledronic Therapy; MORE, Multiple Outcomes of Raloxifene Evaluation; PROOF, Prevent Recurrence of Osteoporosis Fracture; FREEDOM, Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months.

CME Topic



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ferent than in those who were on no medication.38 Best fracture

reduction was seen with 90% compliance. Another study on a

large database39 demonstrated that only 54.6% of patients on

weekly bisphosphonate and 36.9% on daily were compliant (de-

fined only as taking one dose monthly) at one year.

Deciding When to Refer to a Specialist

Clinicians providing primary care may wish to consider

referring the following patients to specialists:

patients not responding to treatment;

patients with the presence of fragility fractures and

normal BMD;

patients with very low BMD;

patients with concerns about the safety of prescribed

medications; and

patients with complex clinical circumstances.

Preventing OsteoporosisPatients with osteopenia and a FRAX score below the

threshold recommended by the NOF to initiate treatment may

be candidates for prevention. The mainstay of prevention is

lifestyle modification, as outlined in the section on treatment.

Some medications are also approved for the prevention of

osteoporosis and are listed in Table 5.

ConclusionEvery adult should be advised on the importance of ade-

quate calcium and vitamin D intake, good nutrition, and healthylifestyle to enhance skeletal health. The assessment of fracture

risk includes BMD testing by DXA in appropriate patients. Pa-

tients who should be considered for pharmacological therapy to

reduce fracture risk are those with osteoporosis by virtue of

having a T-score of2.5 or less or having a history of hip

fracture or vertebral fracture, and those with a T-score between

1.0 and 2.5 who have a high fracture probability using

FRAX. Treatment decisions should be based on all available

clinical information. Patients should be monitored to assure that

the expected treatment effect is achieved and to address side

effects and other patient concerns.

AcknowledgmentsWe thank Ms. Lindy Russell for editorial assistance, and

Dr. Bess Dawson-Hughes, Dr. Wesley Eastridge, and Dr. Jim

Holt for their contributions.

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Zoledronic acid Intravenous Every other year

Raloxifene Oral Daily

Estrogen Variable Variable




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Product Code: SMJ10-10A

Algorithm for the Management of Osteoporosis

October CME Questions

1. The following is/are risk factors for osteoporosis:

A. Early surgical menopause

B. Cigarette smoking

C. Low daily calcium intakeD. A & C

E. All of the above

2. Screening DXA scans are recommended in the following instances:

A. Women aged 65 years and older

B. Men aged 70 years and older

C. Women and men aged 50 years and over with risk factors for osteoporosis

D. A & B

E. All of the above

3. The FRAX score:

A. Estimates the 10-year probability of sustaining an osteoporotic fracture of the hip or other major

bonesB. Should be done in patients with osteopenia

C. Should not be done in patients who have been treated for osteoporosis

D. A & B

E. All of the above

Online CME Request Formhttp://www.sma.org/medallion-level-cmece/cme-credit-form?pcode SMJ10-10A

SMA Southern Medical AssociationAdvocacy, Leadership, Quality and Professional Identity

2010 Southern Medical Association All Rights Reserved.www.sma.org | 35 W. Lakeshore Drive | Birmingham

October2010CMEQuestions-AnswerKe

1.E,2.E,3.E


9/9

Directions: Read the designated article(s), including a review of tables, illustrations, photographs, etc.; complete the self-

assessment test(s) to test your knowledge, and evaluate each article below. To request a CME/CE certificate, complete all

sections of this form and return with payment as directed.

Target Audience: This CME activity was designed for physicians in all specialties and healthcare professionals.

Accreditation/Credit Designation: The Southern Medical Association (SMA) is accredited by the Accreditation Council

for Continuing Medical Education to provide continuing medical education for physicians. The SMA designates this

educational activity for a maximum of1 AMA PRA Category 1 Credit per article. Participants should only claim creditcommensurate with the extent of their participation in the activities.

Nurse CE Contact Hours: The SMA is an approved provider of continuing nursing education by the Alabama State Nurses

Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation; Southern

Medical Association provider #5-125. Each activity qualifies for up to 1 contact hour.

Southern Medical Journals CME/CE Activity

Date of Original Release: October 2010 Expiration: October 2011

Estimated Time of Completion: 1 hour per article

ProductCode: SMJ1010A

Check box(es) below to document your participation in thisJournalCME/CE activity

I attest that I have read the article(s) and completed the self-assessment test(s) as directed.

Time spent:_____ hours_____ minutes.

Maximum award is 1 AMA PRA Category 1 CreditTM per article. Completion Date: ____________________

Name___________________________ Degree(s) __________________ Nursing License # _______________Mailing Address _________________________________ City ____________ State ________ Zip _________

Phone _________________ Fax ________________ E-mail_______________________________________

Specialty_____________________________________

Cost for nonmembers: $15.00 per article: $15 x ____ article(s) = $_________ Total Payment (SMJ

CME/CE activity is free for SMA members)

Credit Card Information

Master Card Credit Card Number ___________________ Expiration Date __________ Security code _______

Visa

American Express

DiscoverSignature________________________________________________________________________________

Check payable to SMA

Billing address (if different from above) ________________________________________________________

Algorithm for the Management of Osteoporosis. Upon completion, participants should be ableto identify risk factors for osteoporosis, more efficiently diagnose osteoporosis, and better utilize clinical

guidelines for the treatment of osteoporosis.

Evaluate these statements as they relate to this article. Agree Neutral Disagree

Presented objective, balanced, scientifically rigorous, evidence-based content

Achieved stated objectives

Satisfied my educational need

Will improve my practice/professional outcomes

How many patients with this condition do you currently treat? (circle) 0, 1-5, 6-10, 11-20, over 20 patients

Outcomes: What changes, if any, do you plan to make in your practice as a result of reading this article?

__________________________________________________________________________________________

Needs Assessment: Clinical topic/experience that most needs to be addressed in future SMJarticles:_______________________________________________________________________________

Please mail completed form to SMA, Attn: SMJCME, 35 W. Lakeshore Drive, Birmingham, AL 35219-0088, or fax to (205) 945-1548

SMA member #

Algorithm for the Management of Osteoporosis.10[1]

Documents

Transcript of Algorithm for the Management of Osteoporosis.10[1]