GUIDELINES FOR THE MANAGEMENT OF OSTEOPOROSIS
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 Bisphosphonate 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
1
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 bisphosphonates 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 Vitamin D
Suggested Investigations
Renal function tests Bone 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/
2
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 Osteopenia 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
3
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 Anticonvulsants Proton pump inhibitors Loop diuretics Ciclosporin A Antiretroviral therapy Heparin
Diseases
Diseases which can increase the risk of developing Osteoporosis or low trauma fracture Rheumatoid arthritis/ 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/Coeliac 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
4
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 Alendronic acid 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 calcium/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
5
- 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
6
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 breast cancer with HRT and its persistence after stopping
18. Strontium ranelate- SmPC and risk minimisation materials
19. Denosumab- SmPC and risk minimisation materials
7
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
8
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 stroke 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
9
READ CODE SUMMARY
Fracture of Skull S0
Fracture of vault of skull S00
Fracture of base of skull S01
Fracture of face bones 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
10
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
11
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
12