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Osteoporosis Clinical Process Framework

Steven Levenson, MD, CMD

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Normal and Osteoporotic Bone

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The Clinical Process Framework Project Now over a decade Started with “Green Bill” Coordinated effort between survey

agency, providers, others Resulting clinical process frameworks

Based on information in AMDA CPGs and other references and resources

A precursor to “Advancing Excellence” process frameworks

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Care Process Steps

Assessment / Problem recognition Diagnosis / Cause identification Management / Treatment Monitoring

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OSTEOPOROSIS Clinical Process Framework

Care process step Expectations Rationale

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ASSESSMENT / PROBLEM RECOGNITION

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Osteoporosis: Assessment / Problem Recognition

Step 1 Did staff and physician seek and

document any history of osteoporosis? Expectations

On admission and thereafter as indicated, staff and practitioner seek and document factors associated with, or presenting risk for, osteoporosis

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Step 1 Rationale

History may include Loss of height History of fractures (often with minimal

or no trauma) Chronic back pain due to vertebral

compression fractures Positive X-Ray finding of thinning of bone

[osteopenia] Positive bone density study (DEXA scan)

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Osteoporosis: Assessment / Problem Recognition Step 2

Did staff identify individuals with (or risk for) osteoporosis and its complications?

Expectations Staff and practitioner

Identify individuals with loss of bone mass and complications related to decreased bone mass

Identify and document risk factors for developing osteoporosis or for worsening of existing bone loss

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Step 2 Rationale Risk factors may be

Modifiable, for example Inadequate calcium and vitamin D intake Excess alcohol intake Smoking Medications that impair bone metabolism

Nonmodifiable, for example Age Female gender Caucasian or Asian race Small body frame

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Step 2 Rationale

Various medications can increase risk of osteoporosis, for example Anticonvulsants, proton pump

inhibitors (PPIs), heparin, thyroid hormone replacement, glucocorticoids, Vitamin A

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Osteoporosis In Men: Significant Risk Factors Age (>70 years) Low body weight (body mass index <20

to 25 kg/m2 or lower) Weight loss (>10% compared with

usual young or adult weight or weight loss in recent years)

Physical inactivity (no regular physical activity; e.g., walking, climbing stairs, housework, gardening

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Osteoporosis In Men: Significant Risk Factors

Use of oral corticosteroids Previous fragility fracture

Reference: Qaseem A, Snow V, Shekelle P, Hopkins Are, Forciea MA, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008 May 6;148(9):680-4

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Step 2 Rationale

May be benefits to addressing modifiable risk factors

Risk factors for complications include Fall history, gait and balance

disturbances, medication adverse consequences, Vitamin D deficiency

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Definitions

Osteoporosis (women) BMD that is 2.5 SD or more below the

mean for women at age 30 Osteopenia

BMD that is 1-2.5 SD below the average, for young, healthy white women.

To date, similar criteria for osteoporosis in men

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Standard Deviations Source:

http://en.wikipedia.org/wiki/Standard_deviation

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Osteoporotic Fracture Risks Over Time

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Hip Fracture Risks in Swedish Women

Source: www.medicographia.com

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DEXA Scanner

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BMD Scoring

T score Compares bone density with that of

healthy young women Z score

Compares bone density with that of other people of age, gender, and race

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BMD Scanning

Also called dual-energy x-ray absorptiometry (DXA) or bone densitometry An enhanced form of x-ray technology

used to measure bone loss Current standard for measuring bone

mineral density (BMD)

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BMD Scanning

DXA most often done on lower spine and hips

CT scan with special software can also be used

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FRAX Scoring

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FRAX Computer-based screening tool that

predicts the risk of developing osteoporosis

Scoring system utilizing BMD results Developed by World Health Organization,

WHO Can help identify individuals who should

have additional testing and treatment, also depending on prognosis

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Osteoporosis: Assessment / Problem Recognition

Step 3 Did staff and practitioner identify

complications of osteoporosis? Expectations

Staff and practitioner collaborate to identify complications

Examples: impaired mobility, pain at fracture sites, deformities, deconditioning, neurological complications, psychological issues

May include in care plan document

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DIAGNOSIS / CAUSE IDENTIFICATION

Step 4 Did practitioner and staff seek causes

of osteoporosis or indicate why causes could not or should not be sought?

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DIAGNOSIS / CAUSE IDENTIFICATION

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DIAGNOSIS / CAUSE IDENTIFICATION

Expectations Identify individuals who may benefit from

additional workup Identify any additional diagnostic workup

indicated to help define presence, severity, and/or causes of decreased bone mass

Collaborate to document rationale for not screening or attempting to confirm suspected diagnosis of bone mass loss

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Step 4 Rationale: Common Causes

Some medications (e.g., Dilantin, steroids)

Hyperthyroidism Hyperparathyroidism Chronic renal failure Malabsorption syndromes Multiple myeloma Vitamin D deficiency

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Step 4 Rationale: Possible Testing

Additional screening or diagnostic testing may not be needed if clinical evidence has already suggested or confirmed condition For example, positive X-Ray showing

bone thinning, a high score on a risk assessment tool, or history of vertebral compression fractures

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Step 4 Rationale: Possible Testing

In absence of existing confirmation of diagnosis, presence of more advanced bone loss or significant complications may warrant screening or diagnostic testing In absence of contraindications (e.g.,

terminal condition or advanced medical illness

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Step 4 Rationale: Possible Testing

Depending on the situation, additional tests may include pDEXA scan for bone density

screening Serum calcium and Vitamin D levels TSH (hyperthyroidism) Renal function tests (chronic renal

failure)

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TREATMENT / PROBLEM MANAGEMENT

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Step 5

Did facility identify and initiate appropriate general and specific interventions?

Expectations Staff and practitioner institute

relevant general and cause-specific interventions, or provide clinically pertinent reason for not doing so

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Step 5 Rationale

Some individuals may benefit from risk reduction and cause management Generic and cause-specific

Generic: those applicable to all at-risk individuals

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Generic Interventions

Calcium (total 1200-1500 mg/day from all sources)

Vitamin D (total 800-1000 IU/day from all sources) supplementation These may reduce additional bone

loss but will not significantly improve existing bone loss

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Generic Interventions

Exercise—especially weight bearing activity—may reduce bone loss

Fall prevention strategies may help reduce falls and subsequent fall-related complications of decreased bone mass

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Vitamin D Vitamin D appears to reduce fall risk

In addition to effects on bone density Serum Vitamin D levels should be at

least 24 ng/ml to reduce fall risk Effect occurs after short duration of use Toxicity is possible although rare Watch for hypercalcemia

May bring out hyperparathyroidism

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Step 6

Did staff and practitioner consider possible individuals for whom additional treatment may be indicated?

Expectations Practitioner and staff identify

individuals who can benefit from additional treatments

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Step 6 Rationale

Several options for medications to try to reverse bone loss

Bisphosphonates Calcitonin Parathyroid hormone Hormone replacement therapy or estrogen receptor

modulators Osteoclast inhibitors

All medications for osteoporosis treatment should be prescribed and given consistent with manufacturers’ specifications and pertinent warnings related to use

Including adverse consequences and drug interactions

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Step 6 Rationale Some individuals may not be able to

tolerate side effects or comply with manufacturer’s specifications for taking these medications

Do vertebroplasty and kyphoplasty help to stabilize vertebral compression fractures? NEJM 2009; 361:557-568 - May be no more

beneficial than medical pain management

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Step 7

Did staff and practitioner address complications and related risk factors?

Expectations Staff institute relevant fall prevention

strategies Staff and practitioner identify and

address symptoms such as pain related to osteoporosis or its complications

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Step 7

Expectations Staff and practitioner evaluate

patient’s current medication regimen and address medications that

Are identified or suspected as affecting bone density

May predispose to complications from osteoporosis; e.g., increase fall risk and thereby may increase risk of fracture

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Step 7 Rationale

Measures to try to prevent falls and related injury may prevent injury-related complications due to osteoporosis

No interventions can prevent all falls Sometimes necessary to focus on trying

to minimize severity of complications, to extent possible

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MONITORING

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Step 8

Did practitioner and staff follow up on individuals with osteoporosis?

Expectations Practitioner and staff monitor

progress of the condition and the individual’s response to any interventions

Based on criteria that are relevant to the individual resident

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Step 8 Rationale

Sometimes difficult to identify specific long-term benefits of osteoporosis treatment in individuals

Examples of monitoring may include—as clinically appropriate—functional capacity, degree of pain, and progression, stabilization, or reduction of bone mass loss

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Step 9

Did staff and physician consider justification for continuing current approaches?

Expectations Staff and practitioner review

information that can help identify the rationale for continuing treatment

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Step 9 Rationale Various circumstances may affect

decisions about continuing or modifying treatments Prognosis Responsiveness to treatment Possibility for changing to a less obtrusive or

lower-risk intervention Resident satisfaction with the benefits of—or

concern about complications related to—treatment

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Step 9 Rationale

Reduced compliance with osteoporosis medications is common Mostly due to adverse consequences

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Step 10

Did staff and practitioner monitor for, and address, complications of osteoporosis and of treatments for osteoporosis?

Expectations Staff and practitioner monitor for, and

manage, complications of osteoporosis and of various treatments for osteoporosis

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Step 10 Rationale

Side effects of osteoporosis medications may include Symptoms of Vitamin D or calcium excess Gastrointestinal irritation including

erosive esophagitis or gastritis (bisphosphonates)

Bone pain Others that are specific for the

medication that is given

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Osteoporosis