GUIDELINES FOR THE MANAGEMENT OF

This document provides management guidelines for clinicians involved in the management of patients with or at risk of osteoporosis

AUTHORS:

Sandra Collins, Sister, DGNHSFT

Suzanne Cooper, Lead Pharmacist Medicines Governance, DGNHSFT

Jane Elvidge, Deputy Chief Pharmacist, DGNHSFT

Jas Johal, Pharmaceutical Consultant, Dudley CCG

Dr Jennifer Marwick, Locum GP and Speciality Doctor in Rheumatology

Dr Andrew Whallett, Consultant Rheumatologist, DGNHSFT

VERSION CONTROL

May 2007 1.0 Guidelines for the Secondary Prevention of Osteoporotic Fragility Fractures in Post-Menopausal Women July 2017 2.0 Minor update- strontium discontinuation Jan 2019 3.0 Minor update Sept 2019 4.0 Minor update- strontium inclusion May 2021 5.0 Link added to length of treatment in osteoporosis: Guidance on treatment break

Ratification date: May 2021 Review date: May 2023

Consultation/Acknowledgements

GPs Drs Nick Plant and Ruth Edwards PBPs Jagdeep Sangha Consultants Dr Atef Michael, Dr Nick Stockdale DIHC Andrew Hindle Dudley MBC Liz Long, Angela Amphlett NOS Katie Hall, Regional Development Manager OPSP Rachael Thornton

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Guidelines for the Management of Osteoporosis

Patients at risk of Osteoporosis

Falls Low Trauma Fracture Drugs Diseases

Osteoporosis

Carry out a FRAX assessment (the WHO fracture risk assessment tool, can be used for people aged between 40 and 90 years, either with or without BMD values) http://www.shef.ac.uk/FRAX/tool.jsp

Lifestyle Advice DEXA scan Prescribe Treatment

Steps to Health : forms can be Dudley DEXA Scan Referral Prescribe first obtained from Greg Southall, Public (2018) line as generic alendronate

Health Practitioner on 01384 814179 70mg weekly, unless

contraindicated or the patient If appropriate refer to Dudley Falls is unable to comply with the Prevention Service administration instructions.

- Short Referral Form - see pg 8 Bisphosphonate holidays

- EMIS embedded professional Other options for treatment referral form include: Strontium ranelate,

Teriparatide and Denosumab. HRT could be considered.

Calcium and

Suggested Investigations

Renal function tests profile LFTs Full Blood Count ESR

Myeloma screen 9am testosterone and SHBG Coeliac Screen Vitamin D

https://pathways.nice.org.uk/pathways/osteoporosis#path=view%3A/pathways/osteoporosis/osteo porosis-assessing-the-risk-of-fragility-fracture.xml&content=view-index

http://www.nos.org.uk/

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Low Trauma Fracture

Emergency department management of fragility fractures http://www.nos.org.uk/ Guidelines for the management of falls in older patients

Dudley Osteoporosis service letter

Patients at risk of Osteoporosis:

Refer to NICE pathway for guidance on the Identification of patients to be reviewed for osteoporosis assessment Pages 2-4

If practice routinely adds ‘fracture’ codes on If practice does not routinely add ‘fracture’ patient computer records codes on patient computer records

+ Those Who Have Had a Previous Fracture Those Who Have a Diagnosis of Osteoporosis

 Read code S1 - fracture of neck and trunk  Read code N330 (parent code)  Read code S2 - fracture of upper limb  Read code S3 - fracture of lower limb Those Who Have a Diagnosis of  Read code NyuBC See page 10 for detailed summary of fracture and osteoporosis read codes Those Who Have Had a DEXA Scan  Read code 58E..(parent code) Within a specified time period e.g. the last year

Those Who Are at Risk  Read code14O9 - at risk of osteoporosis

 Read code14OD - at risk of osteoporotic fracture  Read code 585O - Quantitative Ultrasound Scan result osteoporotic  Read code 585P - Quantitative Ultrasound Scan- result osteopenic Details of further READ codes are available via: www.nos.org.uk/professionals/support -for- professionals.htm Falls Service Codes  Read code 9Og0 - falls risk assessment referral

 Read code 9Og6 - multidisciplinary falls risk assessment done  Read code 66aF - refer for falls assessment + active case finding as appropriate

Falls

Falls documents hyperlinked in the lifestyle box

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Drugs

Drugs that increase the risk of fractures Drugs that increase the risk of falls  Systemic Corticosteroids  Sedatives  Continual or frequent recent use, particularly at  Hypnotics doses and durations above 5mg prednisolone  Anxiolytics daily (or equivalent) for 3 months, rapidly  Antihypertensives increases the risk of osteoporotic fracture.  Drugs with antimuscarinic side effects  The long term use of high-dose inhaled  Drugs that affect the CNS corticosteroids may also contribute to  Antipsychotics corticosteroid- induced osteoporosis.  Antiemetics  Depo-provera  Antidepressants  Aromatase inhibitors  Combinations of drugs (particularly  Androgen Deprivation therapy ‘polypharmacy’ in the elderly)  Antidepressants   Proton pump inhibitors  Loop A  Antiretroviral therapy 

Diseases

Diseases which can increase the risk of developing Osteoporosis or low trauma fracture  / Other inflammatory arthritis  Family history of fracture <75 years old  Malnutrition/Alcoholism  Premature menopause (45 years old, natural or surgical) AND not on HRT  Poor mobility  Inflammatory bowel disease//Chronic liver disease (delete as necessary)  Osteopaenic X-ray  Height loss/ Kyphosis  Hyperparathyroidism/ Thyrotoxicosis(including over-replacement in hypothyroidism)/ Cushing’s  Non-menopausal secondary amenorrhoea /Male hypogonadism  Low BMI (<19 kg/m2)  Chronic Renal Impairment  Any disease increasing the risk of falls: Parkinson’s Disease, Dementia, MS  HIV  COPD

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Prescribe Treatment:

Refer to: http://www.medicines.org.uk/emc/ for further information about each drug

Bisphosphonates

Alendronate and risedronate are effective for preventing postmenopausal osteoporosis or can be a treatment option for postmenopausal osteoporosis. Patients on etidronate should be reviewed and changed to a more effective alternative such as alendronate or risedronate.

For patients with difficulty swallowing tablets consider sodium trihydrate effervescent tablets 70mg.

Bisphosphonate holidays

Bisphosphonates can accumulate in the body because of the drug’s long elimination half-lives. A link has been suggested between prolonged alendronate and probably other bisphosphonate treatment and atypical fractures. 1-7 (usually over 10 years) Bisphosphonates: atypical femoral fractures : MHRA

Consider a ‘drug holiday’ after five years of continuous treatment with oral bisphosphonates. This is to reduce the risk of atypical fractures with prolonged bisphosphonate use. During the drug holiday, any /vitamin D supplements can continue. The positive effect bisphosphonates have on fracture risk appears to be sustained during the period of the drug holiday. For alendronic acid the length of the drug holiday is two years, for risedronate one year before the next five years of bisphosphonates are started again, if still deemed appropriate. An exception is for patients with very high risk of fracture (e.g. if patient is over 75 and has had multiple vertebral fracture) where no drug holiday is recommended.8,13,15

For further information please refer to Bisphosphonate length of treatment in osteoporosis: Guidance on treatment break

Strontium ranelate

 Consider if bisphosphonate contraindicated, or if issues with compliance.  Administered as 2g sachet dissolved in a small amount of water, at bedtime  No calcium-containing food or drink for two hours before. (Calcium supplements should be given as above in the morning).  Refer to 2014 drug safety update highlighting cardiovascular risk, restricted indication and new monitoring requirements for Strontium ranelate. Refer to EMC for SmPC and risk minimisation materials.  Advice for healthcare professionals: - Strontium ranelate is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men at high risk of fracture who cannot use other osteoporosis treatments due to, for example, contraindications or intolerance - Treatment should only be started on the advice of a physician with experience in the treatment of osteoporosis - The risk of developing cardiovascular disease should be assessed before starting treatment. Treatment should not be started in people who have or have had: ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, uncontrolled hypertension

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- Cardiovascular risk should be monitored every 6–12 months - Treatment should be stopped if the individual develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, uncontrolled hypertension, Venous Thromboembolic Events, temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest and hypersensitivity e.g. Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)

Teriparatide

Is recommended as an alternative for women in whom bisphosphonates are contraindicated or not tolerated or where treatment with bisphosphonates has been unsatisfactory AND who comply with NICE guidance TA 161. http://www.nice.org.uk/ta161

Denosumab- see ESCA- http://www.dudleyformulary.nhs.uk/page/47/6-endocrine-system-shared-care

Licensed for the treatment of postmenopausal osteoporosis in women at increased risk of fractures and bone loss associated with hormone ablation in men with prostate cancer at risk of fractures. Given by a subcutaneous injection every 6 months.

Calcium and Vitamin D

Those at risk of osteoporosis (elderly, housebound, those living in care homes) should maintain an adequate intake of calcium and vitamin D and any deficiency should be corrected by increasing dietary intake or taking supplements.

Dudley Formulary choices:

Adcal D3 caplets 2 bd (gelatine free) or Adcal D3 chewable tablets 1 bd (contains gelatine) or Adcal D3 Dissolve Effervescent Tablets- 1 bd

Medicines Q&A- Which Vitamin D preparations are suitable for a vegetarian or vegan diet?

Patients who are at risk of cardiovascular or cerebrovascular events are advised not to receive calcium containing supplements. In this case plain vitamin D is recommended without calcium

Dudley Vitamin D Deficiency guidance

HRT

HRT is effective for prevention of osteoporosis, but its beneficial effect on bone diminishes soon after stopping treatment. Because of the risks associated with long-term use, HRT should be used for prevention of osteoporosis only in women who are unable to use other medicines that are authorised for this purpose.

Click here and here for advice for healthcare professionals to consider before prescribing HRT

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References:

1. Odvina CV, et al. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 2005; 90: 1294–1301. 2. Lenart BA, et al. Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med 2008; 358: 1304–6. 3. Kwek EBK, et al. More on atypical fractures of the femoral diaphysis. N Engl J Med 2008; 359: 316–17. 4. Ing-Lorenzini K, et al. Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a Swiss university hospital. Drug Safety 2009; 32: 775–85. 5. Lenart BA, et al. Association of low-energy femoral fractures with prolonged bisphosphonate use: a case control study. Osteoporos Int 2009; 20: 1353–62. 6. MHRA/CHM. Bisphosphonates: atypical stress fractures. Drug Safety Update 2009; 2 (8): 8. Available at: online (accessed 21/4/13) 7. Osteoporosis- BNF- NHS Evidence. https://bnf.nice.org.uk/treatment- summary/osteoporosis.html 8. Black DM, et al. HORIZON Pivotal Fracture Trial Steering Committee. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med 2010; 362: 1761–71. 9. Shane E, et al. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2010; 25: 2267– 94. 10. Dudley Osteoporosis and Falls Guidelines. Version 7. 2007. 11. Osteoporosis Fragility Fracture NICE Clinical Guideline 146 August 2012 12. NHS Dudley Joint Medicines Formulary- http://www.dudleyformulary.nhs.uk/ 13. Schmidt GA, et al. Risks and benefits of long-term bisphosphonate therapy. Am J Health-Syst Pharm 2010; 67: 994–1001. 14. Ward WG Sr, Carter CJ, Wilson SC, Emory CL. Femoral stress fractures associated with long- term bisphosphonate treatment. Clinical Orthopaedics & Related Research, March 2012; vol./is 470/3;759-65

15. BNF https://bnf.nice.org.uk/

16. Drug Safety Update- HRT updated advice

17. Drug Safety Update- Hormone replacement therapy (HRT): further information on the known increased risk of with HRT and its persistence after stopping

18. Strontium ranelate- SmPC and risk minimisation materials

19. Denosumab- SmPC and risk minimisation materials

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Dudley Falls Prevention Service- Short Referral Form

Client Details

Surname: First Name: Ethnicity:

Date of Birth: NHS No: AIS Pin::

Address: Postcode: Contact numbers:

Yes No NOK Contact Details: Lives alone:

Is an interpreter required? Yes Language:

Any safety concerns for home visits? if No yes please detail

GP Name & Practice: Contact Number:

Referrer details

Name Contact Number

Designation/ relationship to client: Date of referral:

Reason for Referral – please detail as much info as possible

Falls History

Yes Yes Has client fallen? Have they had any near misses?

If Yes: Client reports falling/ near misses ……………. times in ……………. weeks / months / last year

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Yes No Are they fearful of falling?

Client reports having: Palpitations Loss of consciousness Dizziness Mechanical fall Any fractures or injuries sustained (please provide details):

Yes Osteoporosis:

Medical History - please detail as much info as possible including details of any and the dates

Medication:

(Please detail)

1 2 3 4 5 More than 5 Client reports being on the medications

Yes No Would Client benefit from a medication review:

Making a referral

Email: [email protected] or [email protected]

Phone: 01384 814459

Post : Dudley Falls Prevention Service, Brierley Hill Health & Social Care Centre, 2nd Floor , Venture Way, Brierley Hill, DY5 1RU

Please ensure that the above form is completed as thoroughly as possible. Any incomplete referrals will be sent back for further information.

SPA USE ONLY: Outcome :

Tier Zero Stream 1 Stream 2 Stream 3 Med Review

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READ CODE SUMMARY

Fracture of Skull S0

Fracture of vault of skull S00

Fracture of base of skull S01

Fracture of face S02

Other and unqualified skull fractures S03

Multiple fractures involving skull of face with S04 other bones

Fracture of skull NOS S0z

Fracture of neck and trunk S1

Fracture of spine without mention of spinal cord S10 injury

Fracture of spine with spinal cord lesion S11

Fracture of rib(s), sternum, larynx and trachea S12

Fracture of disruption of pelvis S13

Fracture of ill-defined bones of trunk S14

Fracture of thoracic vertebra S15

Fracture of neck and trunk NOS S1z

Fracture of upper limb S2

Fracture of clavicle S20

Fracture of scapula S21

Fracture of humerus S22

Fracture of radius and ulna S23

Fracture of carpal bone S24

Fracture of metacarpal bone S25

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Fracture of one or more phalanges of hand S26

Multiple fractures of hand bones S27

Ill defined fractures of upper limb S28

Multiple # both upper limbs & upper limb with S29 rib & sternum

Fracture of upper limb, level unspecified S2A

Fracture of bone of hand S2B

Fracture of upper limb NOS S2z

Fracture of lower limb S3

Fracture of neck of femur S30

Other fracture of femur S31

Fracture of patella S32

Fracture of tibia and fibula S33

Fracture of ankle S34

Fracture of one or more tarsal and metatarsal S35 bones

Fracture of one or more phalanges of foot S36

Fracture of lower limb level unspecified S37

Other multiple and ill defined fracture of lower S3x limb

Fracture of lower leg, part unspecified S3X

Multiple # both legs, leg + arm, leg + rib + S3y sternum

Fracture of unspecified bones S3z

Fragility fracture due to unspecified osteoporosis N331M

Fragility fracture N331N

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Osteoporosis N330

Osteoporosis unspecified N3300

Senile osteoporosis N3301

Postmenopausal osteoporosis N3302

Idiopathic osteoporosis N3303

Dissuse osteoporosis N3304

Drug induced osteoporosis N3305

Postoopphorectomy osteoporosis N3306

Postsurgical malabsorption osteoporosis N3307

Localised osteoporosis lequesne N3308

Osteoporosis in multiple myelometosis N3309

Osteoporosis in endocrine disorders N330A

Vertebral osteoporosis N330B

Osteoporosis localised to spine N330C

Osteoporosis unspecified N330D

Senile osteoporosis N330z

Femoral neck DEXA scan result osteopenic 58EW

Femoral neck DEXA scan result osteoporotic 58EV

Femoral neck DEXA scan T score 58ES

Femoral neck DEXA scan Z score 58ER

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