Osteoporosis Update. Greg Summers Consultant Rheumatologist

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1 Osteoporosis Update Greg Summers Consultant Rheumatologist

2 DEFINITION OSTEOPOROSIS is LOW BONE MASS (& micro-architectural deterioration) causing AN INCREASED RISK OF FRACTURE

3 23 years 82 years 23 y/o female 82 y/o female

4 Trabecular bone normal osteoporotic

5 Bone turnover in remodelling units OSTEOID 4-6 months mineralisation BONE Approximately 20% trabecular bone is undergoing remodelling at any one time

6 Bone Mass How does bone mass change during our lifetime? Attainment of peak bone mass Consolidation Age-related bone loss Men Menopause Women Ref: Compston JE.Clin Endocrinol 1990 Age (years)

7 What are the consequences of osteoporosis? 1 in 2 women and 1 in 5 men over the age of 50 will sustain a fracture

8 Fragility fractures A fracture due to a fall from standing height or less

9 Incidence % population/year Osteoporotic fractures 4% - Men 4% - Women 3% - = Hip fracture = Vertebral fracture = Forearm fracture 3% - 2% - 2% - 1% - 1% Age group Age group

10 The effects of fractures To the individual Pain Disability Loss of independence Lack of self esteem Death To the NHS At least 1.7 billion per year

11 Loss of vertebral height

12 Vertebral Fractures Substantially Increase the Risk of New Fragility Fractures Women with vertebral fractures have a 5-fold increased risk of a new vertebral fracture 2-fold increased risk of hip fracture

13 Fracture and Disability Disability attributable to aging alone Age

14 Relative Risk of Death Following Clinical Fractures Any Symptomatic Non-spine Hip Spine Forearm Other Age-Adjusted Relative Risk (95% CI)

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16 Assessment of fracture risk In all women aged 65 years and over In all men aged 75 years and over

17 Incidence % population/year Hip fractures 4% - Women 3% - 2% - 1% - Men Age group

18 Targeting risk assessment Assessment of fracture risk In women aged years and men aged years in the presence of risk factors: previous fragility fracture current use or frequent recent use of oral or systemic glucocorticoids history of falls parental history of hip fracture other causes of secondary osteoporosis low body mass index (BMI) (less than 18.5 kg/m2) smoking alcohol intake of more than 14 units per week for women and more than 21 units per week for men.

19 Targeting risk assessment In people under age 50 years only if they have major risk factors: previous fragility fracture current or frequent recent use of oral or systemic glucocorticoids untreated premature menopause

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23 Osteoporosis diagnosis

24 Bone Density Scan

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27 Drugs Update

28 Osteoporosis treatment Bisphosphonates Alendronate Risedronate Ibandronate Zoledronic Acid (intravenous) RANK ligand inhibitor Denosumab Strontium Ranelate Teriparatide

29 Different mechanisms of action Bone preserving therapy anti-resorptive Bone building therapy anabolic

30 Anti-resorptive drugs Bisphosphonates Alendronate Risedronate Ibandronate Zoledronic Acid (intravenous) RANK ligand inhibitor Denosumab Strontium Ranelate Terparatide

31 Bisphosphonates Alendronate Risedronate Ibandronate Zoledronic acid 5mg iv annually

32 Bisphosphonate mechanism of action Bisphosphonate Bone Active osteoclast Inactive osteoclast Apoptotic osteoclast

33 Median Percent Change Antiresorptive drug Bone Turnover Markers Resorption Serum CTX Formation P1NP Month Month

34 Mean ( SE) % Change From Baseline Zoledronate increases Hip BMD over 3 Years Placebo 2.6% ZOL 5 mg 4.7% 5.5% Months 6.4% -1.0% -0.7% -0.9% P < 0.001

35 Denosumab Denosumab is a fully human monoclonal antibody to RANK ligand 6 monthly subcutaneous injection

36 RANK Ligand Is an Essential Mediator of Osteoclast Formation, Function, and Survival Osteoclast precursors Prefusion Osteoclast RANKL RANK Multinucleated Osteoclast Hormones Growth Factors Cytokines Osteoblasts Activated Osteoclast Bone Formation Adapted from: Boyle WJ, et al. Nature. 2003;423: Bone Resorption Do not copy or distribute.

37 Denosumab Binds RANK Ligand and Inhibits Osteoclast Formation, Function, and Survival Osteoclast precursors Pre-fusion Osteoclast RANKL RANK Denosumab Hormones Growth Factors Cytokines Osteoclast Formation, Function, and Survival Inhibited Osteoblasts Bone Formation Bone Resorption Inhibited Adapted from: Boyle WJ, et al. Nature. 2003;423:

38 Antifracture Efficacy of Anti-osteoporotic Agents Incident vertebral fractures - Relative risk Alendronate Risedronate Denosumab Zoledronate Teriparatide 20µg Strontium ranelate RR ± 95% CI

39 Adverse effects of long term anti-resorptive therapy Osteonecrosis of the jaw Atypical sub-trochanteric fractures

40 Osteonecrosis of the jaw

41 Osteonecrosis of the jaw Mainly seen in oncology patients Chemotherapy, radiotherapy, steroids For oral BP or Denosumab the risk is between 1 in 10,000 and <1 in 100,000 Case reports with oral BP for osteoporosis most > 5 years treatment Risk factors Smoking Old age Poor oral hygiene Invasive dental procedures Advanced cancer

42 Atypical femoral fracture Age 64 years, Alendronate therapy for 6 years. Left thigh pain for 3 months

43 Summary of bisphosphonate benefits and risks FRACTURE NNT SIDE EFFECT NNH over 3 years over 3 years Vertebral 14 ONJ >10,000 Non-vertebral 35 ST fracture >3000 Hip 90

44 Drug holiday Bisphosphonates Denosumab Not appropriate due to mechanism of action

45 Biochemical Markers of Bone Turnover in FLEX Participants Serum CTX Black, D. M. et al. JAMA 2006;296: Copyright restrictions may apply.

46 BMD Change in FLEX Participants FIT = Fracture Intervention Trial; FLEX = Fracture Intervention Trial Long-term Extension. Black, D. M. et al. JAMA 2006;296: Copyright restrictions may apply.

47 Bisphosphonates: algorithm for treatment monitoring Advise 3-5 yrs* treatment *3 yrs for zoledronate 5 yrs for other BPs Repeat BMD after 3*-5 years Recurrent fractures BMD lower than baseline and/or T-score -2.5 No fractures BMD not lower than baseline and/or T-score -2.5 Check adherence Exclude 2 causes Re-evaluate treatment choice Continue treatment Consider drug holiday Continue calcium + vit D Repeat BMD in 1-3 yr

48 Median Percent Change Rapid reversal of effect with stopping Denosumab Serum CTX Month stop 48 Stopped Denosumab Continued Denosumab

49 Mean Percent Change in BMD Rapid reversal of effect with stopping Denosumab Lumbar spine BMD continue discontinue Study Months 36

50 Safe Anti-resorptive prescribing Only treat people at high risk of fracture Review necessity for treatment at 5 years and consider a drug holiday in BP users Dental Health Ideally address dental caries/loose teeth prior to BP/Denosumab therapy especially in patients with risk factors for ONJ Regular 6 monthly dental check-ups Ask patient to report dental problems quickly to Doctor or Dentist No evidence that stopping drug prior to dental extraction is necessary Awareness of significance of thigh pain in people on bisphosphonates or Denosumab

51 Anabolic therapy Teriparatide

52 Bone building therapy anabolic Teriparatide

53 Human Parathyroid Hormone 1-34 = Teriparatide H 2 N Ser Val Ser Glu Ile Gln Leu Met His Asn Leu Glu Val 20 Arg Glu Met Ser Asn Leu His Lys Gly Trp Leu Arg Lys Lys Leu Gln Asp Val His Asn Phe COOH

54 Mean % change PTH or PTH peptide Bone Turnover Markers Resorption Serum CTX Formation P1NP months months

55 Effect of Teriparatide Baseline Follow-Up Female, age 65 Duration of therapy: 637 days (approx 21 months) Jiang Y et al. JBMR 2002

56 Strontium Ranelate Mechanism of action uncertain Thought to be related to the incorporation of strontium in to the bone mineral

57 Strontium ranelate Only use In patients who have severe osteoporosis no cardiovascular risk factors low risk of thromboembolism

58 Calcium and vitamin D Osteoporosis therapy should include Calcium 1g daily and Vitamin D 800 IU daily Possible exceptions Younger people with good dietary intake of calcium Some evidence of adverse long term effects of calcium +/- vitamin D (Jury is still out!)

59 Meta-analyses of the effect of calcium supplements with or without vitamin D on cardiovascular events & stroke

60 Any questions?

61 Denosumab adverse effects Not suitable for people with Fructose intolerance Latex allergy Eczema/rash Infection Due to the formulation of the product and composition of the needle hub Cellulitis slightly increased risk Don t use where history of cellulitis/leg ulcers UTI/Chest possible increased risk Recurrent chest or UTI patients may not be suitable

62 Hypocalcaemia risk with Denosumab therapy High risk patients will be kept under secondary care egfr <30 Check before each dose Calcium, vitamin D and egfr Inform patients of possible symptoms of hypocalcaemia within 2 weeks of injection muscle spasms; twitches or cramps; numbness or tingling in your fingers, toes or around the mouth

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