appropriate care guide published: 7 nov 2018 ... · assess osteoporosis risk in post-menopausal...

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Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility fracture or DXA BMD T-score ≤-2.5. Treat patients diagnosed with osteoporosis, or patients with osteopaenia and high fracture risk. Refer selected patient groups to a specialist only when necessary. 1 2 4 3 Osteoporosis is a skeletal disease in which bone density and quality are reduced. Unrecognised or untreated osteoporosis increases fracture risk. Patients suffering hip or spine fractures need long hospitalisations and repeated rehabilitation. Also, these fractures lead to reduced ability to live actively, productively, and independently. As osteoporosis is often asymptomatic until the patient presents with a fragility fracture (a fracture that occurs as a result of minimal trauma, or no identifiable trauma), early identification of patients at Early identification is key to reducing fragility fractures risk is key to fracture prevention. 1 Many factors influence an individual’s likelihood to develop osteoporosis, with age and gender playing key roles. 2,3 A careful assessment of the patient’s risk profile is needed to identify the need for bone mineral density assessment (BMD) using dual energy X-ray absorptiometry (DXA). Low BMD defines presence of osteoporosis, but other elements also have an effect on the risk of fragility fractures. In primary care, recognising the patient’s risk of osteoporosis or fragility fractures can enable appropriate diagnosis and management, keeping the patient fracture-free. APPROPRIATE CARE GUIDE www.ace-hta.gov.sg Published: 7 Nov 2018 Osteoporosis Identification and management in primary care Key messages Chapter of Endocrinologists Chapter of General Physicians Chapter of Rheumatologists College of Physicians, Singapore Chapter of Family Medicine Physicians Academy of Medicine, Singapore College of Family Physicians, Singapore Chapter of Orthopaedic Surgeons College of Surgeons, Singapore

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Page 1: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

Assess osteoporosis risk in post-menopausal women, and men 65 years and older.

Diagnose osteoporosis in patients with a fragility fracture or DXA BMD T-score ≤-2.5.

Treat patients diagnosed with osteoporosis, or patients with osteopaenia and high fracture risk.

Refer selected patient groups to a specialist only when necessary.

1

2

4

3

Osteoporosis is a skeletal disease in which bone density and quality are reduced. Unrecognised or untreated osteoporosis increases fracture risk. Patients suffering hip or spine fractures need long hospitalisations and repeated rehabilitation. Also, these fractures lead to reduced ability to live actively, productively, and independently.

As osteoporosis is often asymptomatic until the patient presents with a fragility fracture (a fracture that occurs as a result of minimal trauma, or no identifiable trauma), early identification of patients at

Early identification is key to reducing fragility fractures

risk is key to fracture prevention.1 Many factors influence an individual’s likelihood to develop osteoporosis, with age and gender playing key roles.2,3 A careful assessment of the patient’s risk profile is needed to identify the need for bone mineral density assessment (BMD) using dual energy X-ray absorptiometry (DXA). Low BMD defines presence of osteoporosis, but other elements also have an effect on the risk of fragility fractures. In primary care, recognising the patient’s risk of osteoporosis or fragility fractures can enable appropriate diagnosis and management, keeping the patient fracture-free.

APPROPRIATE CARE GUIDE www.ace-hta.gov.sgPublished: 7 Nov 2018

OsteoporosisIdentification and management in primary care

Key messages

Chapter of EndocrinologistsChapter of General Physicians

Chapter of RheumatologistsCollege of Physicians, Singapore

Chapter of Family Medicine PhysiciansAcademy of Medicine, Singapore

College of Family Physicians,Singapore

Chapter of Orthopaedic SurgeonsCollege of Surgeons, Singapore

Page 2: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

Recognising patients with osteoporosis risk or high fracture risk is key in identifying those who will benefit from further evaluation, counselling, and treatment. As age and gender are well-established osteoporosis risk factors, the risk profile of post-menopausal women, and men 65 years and oldera should be further assessed. Several risk factors are known to be associated with osteoporosis and fragility fractures (Table 1).

When assessment is conducted in post-menopausal women, the Osteoporosis Self-Assessment Tool for Asians (OSTA) can support detecting a woman’s osteoporosis risk.4

Based on the woman’s risk as per the coloured chart:

• High-risk (>20) consider DXA scan as the chance of finding osteoporosis (low BMD) is high in this group

• Medium-risk (0-20) consider DXA scan if any other risk factor(s) (Table 1) for osteoporosis is present

• Low-risk (<0) consider deferring DXA

In patients initially deemed low risk, reassess risk if there has been significant weight loss or any clinical risk factor development since the last visit, or if last assessment was five or more years ago.

Identifying patients at risk

Table 1. Risk factors for osteoporosis or fragility fractures

a Possible osteoporosis risk should be explored in men younger than 65 years if they have significant risk factors such as use of steroids or anti-androgens, or medical conditions associated with bone loss such as hypogonadism or hyperthyroidism.

Figure 1. OSTA for risk assessment in post-menopausal women

OSTA score = age in years − weight in kg

Weight (kg)

40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94

Age

(ye

ars)

40-44

45-49

50-54

55-59

60-64

65-69

70-74

75-79

80-84

85-89

90-94

95-99

High risk

Medium risk

Low risk

Family history of osteoporosis or fragility fractures Certain medications^

Previous fragility fracture Low calcium intake (<500 mg/day)*

Ageing Excessive alcohol intake (>2 units/day)

Low body weight Smoking (any)

Height loss (>2 cm within three years) Prolonged immobility

Early menopause (45 years and younger) History of falls

Presence of diseases that can lower bone density or increase fracture risk#

^ Such as prolonged corticosteroid use (>5 mg/day of prednisolone or its equivalent for >3 months in the past year)* Calcium intake calculator: www.healthhub.sg/live-healthy/216/calcium_greater_bone_strength# Such as diabetes mellitus, or any inflammatory rheumatic disease

Give lifestyle advice to all patients at risk of osteoporosis or fractures (especially to post-menopausal women, and men 65 years and older).

Assessing fracture risk using the Fracture Risk Assessment Tool FRAX®

FRAX® calculates one’s fracture risk (FRAX score can be calculated at sheffield.ac.uk/FRAX). It determines the 10-year probability of having a fracture using age, body mass index, and other risk factors.8 FRAX® helps better understand the patient’s fracture risk to aid decision for further assessment (see ‘When to start treatment’ section for more information on FRAX®).

2

Page 3: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

Lifestyle advice for all patients at risk

Healthy lifestyle choices can reduce osteoporosis-associated risks. However, when pharmacological treatment is indicated, lifestyle management is not considered a substitute.

• Advise on appropriate calcium intake (1,000 mg/day of elemental calcium for healthy adults 51 years and older, and 800 mg/day for adults 19 to 50 years old*)

• Optimise vitamin D intake (51 to 70 years old = 600 IU/day; >70 years old = 800 IU/day^)• Advise on appropriate weight-bearing, muscle-strengthening, and balance exercises such as walking, elastic

band exercises, and Tai Chi• Advise on smoking cessation and appropriate alcohol intake• Educate on fall risk, home safety, and footwear• Educate patient about osteoporosis and fragility fractures and their implications

The diagnosis of osteoporosis is universally defined by either the presence of a fragility fracture, or a hip and/or spine DXA BMD T-score of -2.5 or lower.5,6,7 DXA is the standard technique for measuring BMD. BMD measurements of the hip and spine are widely accepted for the diagnosis. Consider adding vertebral fracture assessment (VFA) or a thoracolumbar (TL)

Making a diagnosis

Table 2. Laboratory tests to identify secondary contributors of osteoporosis

Other disease states that can act as secondary contributors: Cushing’s syndrome, chronic obstructive pulmonary disease, organ transplantation, and anorexia nervosa ^ Repeated tests are not needed* Fasting needed for more accurate results† Urinary calcium/creatinine level >0.6 (urine calcium and urine creatinine in mmol/l) suggests the need to do 24-hour urine calcium test # In men <70 years of age or in those with hypogonadal symptoms. Morning test recommended for more accurate results

X-ray to identify vertebral fractures in older adults with height loss or lower back pain.

After diagnosis, a careful clinical history and physical examination is required, and the laboratory tests below should be considered to exclude secondary contributors of bone loss (Table 2).

* Source: Singapore Health Promotion Board^ Source: Institute Of Medicine

Test Clinical rationale

More commonly indicated

CreatinineDetermines baseline renal function to inform treatment choice (may also indicate presence of chronic kidney disease-mineral and bone disorder [CKD-MBD])

Full blood count Identifies a range of disorders, including presence of malignancies and malabsorption

Corrected calcium Increased level might indicate primary hyperparathyroidism or malignancy; decreased level might indicate malabsorption or vitamin D deficiency

25-hydroxy vitamin D^ To test baseline level for vitamin D (aim for >20 ng/mL for optimal bone and muscle strength)

Others Thyroid-stimulating hormone

Decreased levels might indicate hyperthyroidism or over-replacement with thyroxine

Erythrocyte sedimentation rate (ESR)

Very high ESR might indicate rheumatological disease. A raised ESR in association with raised creatinine and anaemia might indicate haematological disease such as myeloma

Alkaline phosphatase Increased levels might indicate liver disease, Paget’s disease, recent fracture, or other bone pathology

Serum phosphate* Abnormal levels might indicate vitamin D deficiency or renal phosphate wasting

Spot urine calcium/creatinine ratio Elevated levels might indicate idiopathic hypercalciuria†

Serum total testosterone# Decreased levels might indicate hypogonadism

3

Page 4: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

b Or more than the least significant change (LSC) at the particular centre (DXA centres are encouraged to calculate their own precision errors and LSCs according to the International Society of Clinical Densitometry [ISCD] standards). For the purpose of monitoring, DXA scans should ideally be repeated at the same centre.

Treatment monitoring

Consider DXA BMD at baseline, after one to two years of treatment (to establish clinical effectiveness), and every two to three years thereafter. Assess for significant DXA BMD deterioration of >4–5% compared to previous measurement and for any fracture occurring while on medication (including asymptomatic vertebral fractures).

Consider referring only selected patient groups to a specialist.These include:

• Creatinine clearance estimated by Cockcroft-Gault equation <30 mL/minute• Confirmed or strongly suspected complex secondary causes• Patients with multiple fragility fractures AND very low DXA BMD (T-score <-3.0)• Patients who adhere to treatment and experience fragility fractures or continued bone loss (>4–5% deterioration

in DXA BMDb) after at least a year of treatment. Before referring these patients, consider reviewing secondary contributors of osteoporosis and/or switch to intravenous or subcutaneous therapy to negate problems of poor gut absorption or poor compliance with oral therapy

The choice of specialist depends on the reason for referral.

Referring patients

Fragility fracture

A fracture (such as that of the vertebra, hip, femur, pelvis, humerus, or wrist) that occurs as a result of minimal trauma (such as a fall from standing height or less) or no identifiable trauma. Metatarsal, metacarpal, and phalangeal fractures are not considered osteoporotic or fragility fractures.

Asymptomatic vertebral fractures can be visually identified as ≥20% decrease in vertebral height (anterior, mid, or posterior dimensions). These are common fragility fractures and should be correctly recognised.

Treatment decision-making involves exercising clinical judgement in weighing overall risks and benefits of different management options in individual patient circumstances, and discussing with the patient (including treatment duration). Consider starting anti-osteoporosis treatment in the following groups:

• Patients presenting with a fragility fracture5,6,7

• Patients without a fragility fracture, but with DXA BMD T-scores of ≤-2.55,6,7

• Osteopaenic patients (DXA BMD T-scores >-2.5 but <-1) without a fragility fracture, but with high fracture risk

When to start treatment Assessing fracture risk using FRAX®

FRAX® is a useful tool to determine absolute fracture risk and assist in treatment decisions (sheffield.ac.uk/FRAX). The 10-year probability of developing a fracture estimated by FRAX® should be interpreted in light of individual patient circumstances, as the parameters used by FRAX® in the calculation are not exhaustive. Although other fracture risk calculators are available (such as Garvan fracture risk calculator or QFracture), FRAX® is recommended given its multi-country validation and the availability of a Singapore model. FRAX® thresholds for treatment should be country-specific.8 Singapore-specific thresholds are under development and will be made available at ace-hta.gov.sg once validated.

Scan to go to FRAX® calculator website

4

Page 5: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

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Page 6: APPROPRIATE CARE GUIDE Published: 7 Nov 2018 ... · Assess osteoporosis risk in post-menopausal women, and men 65 years and older. Diagnose osteoporosis in patients with a fragility

3

References

Expert Group

Lead discussant

Dr Chionh Siok Bee (NUH)

Chairperson

Dr Manju Chandran (SGH)

Group members

Dr Ang Seng Bin (KKH)

Dr Lydia Au (NTFGH)

Dr Linsey Gani (CGH)

A/Prof Goh Seo Kiat (SGH)

Dr Koh Thuan Wee (Frontier Healthcare Group)

A/Prof Lau Tang Ching (NUH)

Dr Gilbert Tan (SHP)

Dr Donovan Tay (SKGH)

Dr Tng Eng Loon (NTFGH)

About the Agency

The Agency for Care Effectiveness (ACE) is the national health technology assessment agency in Singapore residing within the Ministry of Health (MOH). ACE develops evidence-based “Appropriate Care Guides” or ACGs to guide a specific area of clinical practice. ACGs are aimed at complementing MOH Clinical Practice Guidelines when these are available, by providing additions and updates as reflected in the evidence at the time of development, and incorporating cost-effectiveness considerations where relevant. The ACGs are not exhaustive of the subject matter. When using the ACGs, the responsibility for making decisions appropriate to the circumstances of the individual patient remains with the healthcare professional. This ACG will be reviewed 3 years after publication, or earlier, if new evidence emerges that requires substantive changes to the recommendations.

Find out more about ACE at www.ace-hta.gov.sg/about

© Agency for Care Effectiveness, Ministry of Health, Republic of SingaporeAll rights reserved. Reproduction of this publication in whole or in part in any material form is prohibited without the prior written permission of the copyright holder. Application to reproduce any part of this publication should be addressed to:

Agency for Care EffectivenessEmail: [email protected]

In citation, please credit the “Ministry of Health, Singapore”, when you extract and use the information or data from the publication.

Driving better decision-making in healthcare

Agency for Care Effectiveness (ACE)College of Medicine Building16 College Road Singapore 169854

1. IOF (2013). THE ASIA-PACIFIC REGIONAL AUDIT: Epidemiology, costs & burden of osteoporosis in 2013.

2. Kanis JA, et al. (2004). A meta-analysis of previous fracture and subsequent fracture risk. Bone 35: 375–382.

3. Klotzbuecher CM, et al. (2000). Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. Journal of Bone and Mineral Research 15: 721–739.

4. Koh LK, et al. (2001). A simple tool to identify Asian women at increased risk of osteoporosis. Osteoporosis International 12: 699–705.

5. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for The Diagnosis and Treatment of Postmenopausal Osteoporosis, 2016 (American Association of Clinical Endocrinologists [US])

6. Management of osteoporosis and the prevention of fragility fractures, 2015 (142) (SIGN [UK]—website reference from www.sign.ac.uk)

7. Osteoporosis prevention, diagnosis and management in postmenopausal women and men over 50 years of age, 2017 (Royal Australian College of General Practitioners [RACGP] and osteoporosis Australia [OA])

8. Kanis JA, et al. (2016) A systematic review of intervention thresholds based on FRAX A report prepared for the National Osteoporosis Guideline Group and the International Osteoporosis Foundation. Archives of Osteoporosis 11: 25