HILLINGDON PRIMARY CARE TRUST GUIDELINES FOR THE MANAGEMENT OF OSTEOPOROSIS & MENOPAUSAL SYMPTOMS - December 2008 Definitions

WHO definition of osteoporosis: A disease characterised by low bone mass and microarchitectural deterioration of bone tissue, leading to enhanced bone fragility and consequent increase in fracture risk. Osteoporosis is caused by an imbalance between the relative rates of bone resorption and formation. Climacteric is the process (natural or iatrogenic) that occurs over a period of years in a woman's late 40s or early 50s when her supply of ovarian follicles declines and her menstrual cycle becomes irregular and / or stops completely.

Incidence: 1 in 3 women and 1 in 8 men aged over 50

Major Risk Factors for Osteoporosis
1. Previous low trauma or fragility fracture (Strong risk for future fracture so treatment should be started whilst waiting for scan) 2. Oestrogen deficiency in women: menopause or hysterectomy <45 years, secondary amenorrhoea > 6 months not due to pregnancy, primary hypogonadism 3. Family history: maternal hip fracture 4. X-ray evidence of osteopenia 5. Primary or secondary hypogonadism in men 6. Low BMI (<19kg/m2), height loss, kyphosis 7. Secondary osteoporosis: primary hyperparathyroidism, hyperthyroidism, poorly controlled thyrotoxicosis, malabsorption, inflammatory arthritis, liver disease, alcoholism. 8. Patients currently on drugs such as steroids ( > 5mg prednisolone/day for 3 months or more), chemotherapy and long term warfarin or anticonvulsants. 9. Poor mobility (see risk factors for recurrent falls) ---------------------------------------------------------------------------------------------------------------------------10. Smoking & heavy drinking are risk factors only if additional to risks 1 to 9.

Peripheral DEXA Scans
All patients with risk factors should have BMD assessments carried out via peripheral DEXA scans. These forearm or heel scans are mobile, so more easily obtained that the gold standard DEXA scans. They are well validated techniques (Blake et al). The same clinical decision would be made no matter which skeletal site is measured (Nelson et al). Peripheral DEXA scans are useful for initial screening purposes for gold standard DEXA scan candidates. The gold standard measures BMD at the hip & spine and is more strongly predictive of hip fractures than BMD assessments at peripheral sites (Black et al).
N.B.

1. 2.

There is no need to scan patients 75 yrs & above prior to starting treatment if they have sustained minor trauma fracture. They need blood tests to rule out causes of secondary osteoporosis. Peripheral scans are of no use in monitoring effects of treatment.

Investigations
The following baseline investigations should be done for patients over 65 years with a diagnosis of osteoporosis where indicated: ♦ FBC (for malabsorption), ESR or plasma viscosity (for myeloma) ♦ Bone profile & liver function tests -Ca, P, alk phos, albumin, AST/gamma GT ( for liver disease) ♦ Serum creatinine (for kidney disease) ♦ Serum TSH (for hyperthyroidism) ♦ Serum parathormone ♦ Testosterone & SHBG (serum human binding globulin)for all men (for gonadal failure) ♦ Protein electrophoresis & Bence Jones Protein in 24 hour urine for everyone with frank osteoporosis on peripheral scan (for multiple myeloma) ♦ Serum vitamin D in Indian sub-continent patients & others from high risk group. 1

Gold Standard DEXA Scans
1. For patients whose peripheral
DEXA scan reveals T score of –1.4 to –2.6 with major risk factors, and for women who do not or cannot take HRT prevention, or men with fracture risk (excluding <80 yrs (NOS Position Statement) For patients with history of fracture while taking bisphosphonates.

2.

HRT for women First line for women with premature menopause up to age 50 and for women over 50 with menopausal symptoms & osteoporosis. Cost~ £35. Bisphosphonates – Generic alendronic acid or risedronate (See pg 3) Secondary Care (Not in any order of choice) 2. NB: May be cumbersome to put on. Strontium 3. ischaemic heart disease. 4.WHO Classification of BMD T-scores – Gold Std at hip & spine Low risk Medium risk High risk Young adult mean Osteopenia – low bone mass.1200 to 1500mg daily ♦ Lifestyle advice e. weight bearing exercise such as a brisk walk. Pharmacological Treatment of Osteoporosis Primary care FEMALES 1. Additional therapy: Calcium & Vitamin D for patients over 80 years DEXA scans are of no value for this age group. TIA. (Absolute contra-indications: breast ca. treadmill and stair climbing. ♦ Hip protectors: Useful for frail elderly patients (over 80 years) at high risk of falling. suitable for bone-loss prevention treatment Osteoporosis – High fracture risk Severe osteoporosis – very low T-score PLUS at least one vertebral fracture 0 to -1 -1 to -2. NSAIDs. lumbar supports. CVA. DVT. 5.g. Strontium ranelate for those unable to tolerate or unwilling to take bisphosphonates or where HRT is contraindicated 3. TENS ALL FRACTURE PATIENTS 1. ♦ Physiotherapy for improvement of balance and muscle strengthening especially for people with poor mobility & recurrent falls. Additional therapy: Calcium & Vitamin D Analgesia where osteopenic fracture is suspected Simple analgesics.2. active endometrial cancer) 4.5 Less than .5 General Measures on Prevention of Osteoporosis (All patients with osteoporosis and at risk of osteoporosis) ♦ Dietary advice: balance with adequate protein and calcium . ♦ Calcitonin nasal spray or injection ♦ Fluoride ♦ Anabolic steroids Vitamin D metabolites & analogues ♦ Pamidronate IV Infusion ♦ Raloxifene ♦ Teriparatide (PTH) ( PBR-excluded 09/10) ♦ Zolendronic acid ♦ Ibandronic acid Analgesia (as above) Ibandronic acid IV in patients intolerant to oral bisphosphonates 2 . Bisphosphonates 2.

multiple myeloma or malabsorption. Patients Already on Treatment ♦ Patients who develop a breast lump after initiating therapy with HRT ♦ Sequential HRT – persistent heavy period for > 6 months ♦ Continuous combined therapy – Bleeding 6 months after becoming completely ammenorheic (it may take 6-10months after initiation to become ammenorheic and slight irregular bleeding during this stage is acceptable) ♦ Perimenopausal women – persistent post-coital bleeding / or persistent inter-menstrual bleeding ♦ Treatment resistant osteoporosis – second DEXA scan 2 years later 3 . Generic alendronic acid 10mg daily / Generic alendronic acid 70mg once a week or Risedronate 5mg od / Risedronate 35mg weekly (3) Strontium ranelate – 2g sachet daily in water on an empty stomach 2 hours after evening meal. ♦ HRT doses for prevention of osteoporosis . reduce fracture risk. (2) Bisphosphonates . They are licensed for the treatment & prevention of osteoporosis in post-menopausal women. but most of the evidence for anti-fracture efficacy has been obtained with calcium in combination with Vitamin D.Pharmacological Treatment Continued (1) Hormonal Replacement Therapy The drug treatments recommended in Appendix A retard bone loss and are evidence-based and costeffective. and are evidence-based & cost-effective. but the effects are less marked than those of HRT & bisphosphonates. There is evidence to show a reduction of vertebral fractures with calcium alone. This is the treatment of choice where there is a significant osteoclastic asctivity causing increased resorption. ≥ 0. (4) Calcium supplements – For dietary-deficient calcium or patients with malabsorption syndrome and poor mobility Supplements of 1g or more daily decrease bone loss in elderly women.≥ 2mg oral oestrogen. which needs investigation and treatment should be referred to appropriate consultant. ≥ 50mcg patch. Adcal-D3 Two tablets daily or Calcichew D3 Forte Referral to Secondary Care Initial Assessment Referrals ♦ ♦ ♦ ♦ History of thrombosis or strong family history of thrombosis where HRT is being considered Any post-menopausal bleeding with unconfirmed diagnosis where HRT is being considered Breast lump with unconfirmed diagnosis where HRT is being considered Perimenopausal women – persistent post-coital bleeding / or persistent inter-menstrual bleeding where HRT is being considered ♦ Significant abnormalities from baseline investigations – secondary cause of osteoporosis ♦ Patients with secondary cause e.625mg conjugated equine oestrogen. Bisphosphonates inhibit bone turnover & reduce the risk of bone fracture.g.(Alendronic acid & Risedronate) The drug treatments recommended below retard bone loss.

Patients with an osteopenic T score on forearm DEXA should be referred for hip and spine DEXA scan (Gold standard) if they develop additional risk factors. including a regular clinical pelvic examination and pelvic ultra sound. Monitoring Patients on HRT Monitoring should be undertaken at 3 months after starting HRT and then every 6 months ♦ Menopausal symptom control ♦ Bleed pattern (non-hysterectomised women) ♦ Day of onset and duration ♦ Amount of flow ♦ Any breakthrough bleeding ♦ Side-effects and their management ♦ Health education and advice ♦ Smoking. After 5 years on HRT beyond the age of 50 an individual risk benefit assessment should be made to decide if HRT should be continued. This exercise should be repeated after 10 years HRT use after the age of 50. if applicable ♦ Review treatment strategy and continued need for HRT Women with history of endometriosis or fibroids should receive careful supervision. Patients on Bisphosphonates and /or Strontium • Routine monitoring of patients on these drugs is not recommended unless a patient sustains a fragility fracture whilst on treatment. diet and exercise ♦ Self breast awareness ♦ Regular attendance for breast and cervical screening ♦ Stress management ♦ BMI and BP ♦ Contraceptive advice.♦ Patients with complications such as multiple co-morbidities ♦ Patients not tolerating or have contraindications to oral bisphosphonates and/or strontium ♦ Patients who have sustained fragility fracture whilst on osteoporosis treatment with good compliance. • 4 .

♦ Visual impairment. Older people who fall should be recalled to the surgery or assessed in their homes for review. ♦ Steep stairs and slippery floors ♦ Inaccessible lights or windows. particularly on the stairs. grab rails.e. including physiotherapy. gait or mobility problems (including joint disease. to improve confidence ♦ Occupational therapy to identify and correct hazards in the home ♦ Repairs and improvements to the home ♦ Exercise and balance training ♦ Use of hip protectors ♦ Treatment of osteoporosis 5 . if possible ♦ Correction of postural hypotension ♦ Medication review and discontinuation of inappropriate medication ♦ Rehabilitation.g. particularly centrally sedating or blood pressure lowering drugs. ♦ Postural hypotension. ♦ Badly fitting footwear or clothing. Environment risk factors ♦ Poor lighting. ♦ Lack of safety equipment e. stroke and Parkinson's disease) ♦ Polypharmacy i. particularly those who: ♦ Have previous fragility fractures ♦ Have attended accident and emergency following a fall ♦ Have called an ambulance following a fall ♦ Have two or more patient risk factors ♦ Have frequent unexplained falls ♦ Fall in hospital or in a nursing or residential home ♦ Live in unsafe housing conditions ♦ Are very afraid of falling Interventions to reduce the risk of falls and injury from falling: ♦ Assessment and correction of vision. ♦ Impaired cognition or depression. taking four or more medicines. ♦ Loose carpets or rugs.Assessing the Risk of Falls and Appropriate Intervention Patient risk factors ♦ Balance.

625mg + Oestradiol 50mcg + Medroxyprogesterone 5mg (C21) Norethisterone NB: Switch from oral to non-oral prep if 170mcg (C19) LFTs are raised.26mg+ Norgestrel 150mcg Patches Evorel Pak (patch & tab) oestradiol 50mcg + Norethisterone 1mg (C19) Reasons to Commence / Switch Patches preferred if malabsorption. Oestradiol 2mg + Dydrogesterone 10mg Persistent breast tenderness / headaches: Dydrogesterone 10mg (C21) (C21) reduce dose of oestrogen.625 + Medroxyprogesterone 5mg (C21) Indivina Estradiol valerate + Medroxyprogesterone 6 Patches Evorel Conti Oestradiol 50mcg + Norethisterone 170mcg (C19) Reasons to Commence / Switch Patches preferred if malabsorption. tab) Avoid (C21) if history of depression. Also for persistent side-effects on tablets. Switch from (C19) to (C21) if acne / oily skin. switch to patch Premique Cycle Evorel Sequi (patch) or switch type of oestrogen. mood changes. hirsuitism.To be used when: Period free HRT is required – patients should be amenorrhoeic for >1 year or > 54 years of age. Femoston Oestradiol 80mg + post-natal depression. switch to patch or switch type of oestrogen. abnormal liver function. coeliac disease. inc perinatal depression. Tablets Elleste Duet Conti Oestradiol 2mg + Norethisterone 1mg (C19) Femoston Conti Oestradiol 1mg + Dydrogesterone 5mg (C21) Kliovance Estradio 1mg + norethisterone 500mcg (C19) Premique Conj. . history of Femapak (patch & severe PMT. Avoid (C21) if history of depression. coeliac disease. colitis. Also for persistent side-effects on tablets.To be used for: Perimenopausal women with intact uteri. 0. Tablets Elleste Duet Oestradiol 2mg + Norethisterone 1mg (C19) Prempak C Conj Oestrogens (equine)1. colitis. hirsutism. Switch from (C19) to (C21) if acne / oily skin. mood changes.3 TABLE B Continuous combined Preparations . equine oestr. or if patient is a diabetic with triglyceride >2. inc. 0. equine oestr.APPENDIX A ______________________________________________________________________________ TABLE A Sequential Preparations . history of severe PMT. Persistent breast tenderness / headaches: reduce dose of oestrogen. Conj. abnormal liver function.

coeliac disease. recommend use daily for 2 weeks.625mg Elleste Solo Oestradiol 1mg & 2mg micronised Climaval Estradiol 1mg & 2mg Zumenon Estradio 1 and 2mg TABLE D Topical .To be used for : Relief of vaginal symptoms and bladder symptoms (urgency and urge incontinence) Ortho-gynest cream or pessary (oestriol) Lowest possible dose and discontinued as soon as possible. 100mcg Reasons to Commence / Switch Patches preferred if malabsorption. abnormal liver function.To be used ONLY if patient is hysterectomised Patches Evorel oestr. Also for persistent side-effects on tablets. It treatment is required for more than 3 months twice weekly. Review every 3-6 months. colitis. equine 0. breast tenderness or breakthrough bleeding not resolved by dose and formulation changes.5mg Use when others not tolerated _ Reserve tibolone for patients with low libido. TABLE C Unopposed Oestrogen . SIDE EFFECTS OF HRT Oestrogenic side effects Progestogenic side effects Breast tenderness Irregular bleeding Water retention Weight gain Mild depression Irritability Abdominal bloating Acne Hirsutism 7 . To avoid systemic absorption. Oestradiol 50mcg. Tablets Premarin Conj. then twice a week for 3 months. then once a week if bladder symptoms recur. patients should be prescribed an oral progestogen daily to combat endometrial hyperplasia.Livial Tibolone 2. 75mcg.

increased risk.APPENDIX B Hillingdon Osteoporosis Guideline Development Group MEDICAL MANAGEMENT OF PATIENTS AT RISK OF OSTEOPOROSIS (10.4 Osteopenia T score -1.6 Osteoporosis T score below -2.4 to -2. 2.6 Women or men on long term steroids 8 . 3. + / .11.housebound Previous fragility fractures for under 75 years (Over 75s – no need for scan before treatment is started) Investigations Measure BMD with Peripheral Scanner Normal T score 0 to -1.4 to -2.e.08) Risk Factors Frail. Patients with history of fracture whilst on treatment with bisphosphonates Osteopenic on peripheral DEXA scan i. T score -1.6 Reassure Lifestyle advice Give lifestyle advice Calcium & vitamin D is needed Treat if previous fracture Lifestyle advice & Pharmacological treatment Refer for Gold Standard DEXA Scan 1.

wrist. but it is hoped that this will be available soon. what is the score? Score (0 to 5) 1 for yes 1 for yes 1 for < 125lbs(57kg) 1 for yes 2 for yes 0 to 4 FRAX FRAX is a WHO-supported tool for fracture risk prediction available on www.Calcium & Vitamin D Falls risk: Assessment / advice Consider hip protectors Previous fragility fractures Previous fragility fractures are a strong independent risk for further fracture.ac. spine or humerus) or a hip fracture. stones or kg? Are you currently a smoker? Do you usually need to use your arms to assist yourself in standing up from a chair? If you have a current bone density assessment (BMD). the patient needs re-assurance & lifestyle advice. Question What is your current age? Have you broken any bones after age 50? Has your mother had a hip fracture after age 50? What do you weigh in lbs. This assessment tool can be used with or without BMD measurements. Hillingdon GP Vasundra Tailor. Head of Medicines Management 9 . and for whom further clinical assessments and intervention are most warranted. Current NICE guidelines do not incorporate the FRAX tool for fracture risk prediction.shef. pharmacological treatment may be required. to reduce fracture risk. It is an algorithm now used worldwide to express the risk of fracture as a 10 year probability either for a major osteoporotic fracture (hip. non-vertebral and vertebral fractures over the subsequent 5 years. Krishna Sethi. It can be used with or without BMD measurements. If above 6. If the total score is below 6.uk/FRAX. Updated by: Dr. Treat without BMD if medical history is unequivocal in patients 75 years and above Adapted from the Royal College of Physicians Osteoporosis Report 1999 APPENDIX C Fracture Index Rating Useful as a 3-minute questionnaire to identify those at high risk of hip.

Issued: December 2008 Valid until: December 2010 10 .