Osteoporosis update. Dr. Claire Vandevelde Consultant Rheumatologist, LTHT

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1 Osteoporosis update Dr. Claire Vandevelde Consultant Rheumatologist, LTHT

2 Outline Background BMD Tools for assessing fracture risk Case study Denosumab Treatment breaks

3 BMD BMD predicts fracture risk but this detects change in the mineralisation of bone and not microarchitectural changes BMD influenced either by: Inadequate development of peak bone mass (largely genetic) Excessive loss of bone mass (largely environmentalhormones, activity and calcium intake)

4 Factors other than BMD BMD predicts fracture risk- no threshold, so the lower the BMD the higher the fracture risk Some risk factors for fracture are independent of BMD: Excess alcohol Family history of fracture Smoking Low body weight

5 Tools for assessing fracture risk

6 FRAX Age >40 Now adjusted for steroid doses Underestimates the short-term risk of fracture in the elderly Unclear how relevant it is for patients already on treatment Does not take into account falls risk Does not include vertebral fractures

7 Case study 62 year old Referred by GP for second opinion for osteoporosis treatment Please see this lady with osteoporosis who is worried about the side-effects of potential treatment. She has had two previous fragility fractures and DXA has confirmed osteoporosis. T-2.5 at the hip

8 Very fit and well 2 previous fractures Case study Age 52- fractured femur- fell while skiing Age 40ish- fractured wrist- fell off pedal bike Neither are fragility fractures- both with reasonable trauma Mother had fractured her NOF

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13 Denosumab

14 Prolia (denosumab) binds to RANK Ligand and inhibits osteoclasts in both cortical and trabecular bone CFU-GM PREFUSION OSTEOCLAST RANKL RANK OPG 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: Baron R et al. Bone 2011; 48: Boyle WJ et al. Nature 2003; 423: Slide provided courtesy of Amgen

15 Prolia (denosumab) inhibits osteoclast formation, function and survival, whereas bisphosphonates inhibit function once taken up by the osteoclast Adapted from Baron R et al. Bone 2011; 48: Baron R et al. Bone 2011; 48: Slide provided courtesy of Amgen

16 Ten Years of Denosumab Treatment in Postmenopausal Women With Osteoporosis: Results From the FREEDOM Extension Trial. Bone HG, et al. J Bone Miner Res. 2015; 30(Suppl 1): S471;LB1157

17 Percent Change from Baseline FREEDOM extension trial Placebo n=3906 FREEDOM Cross-over Denosumab n= Study Year Continued Denosumab n=2343 Lumbar Spine BMD * Total Hip BMD * Extension Study 21.7% 16.5% FREEDOM Extension Study 9.2% 7.4. % Study Year BMD: bone mineral density Compared with FREEDOM baseline, extension baseline, and previous measurement. All values all P < *BMD data results are not meant to imply fracture efficacy and should not be extrapolated to predict differences in fracture efficacy Adapted from Bone HG, et al. J Bone Miner Res. 2015; 30(Suppl 1):S471;LB1157 Prolia ( denosumab) Summary of Product Characteristics

18 FREEDOM extension trial Conclusion: Denosumab treatment for up to 10 years was associated with persistent reduction of bone turnover, continued increases in BMD without therapeutic plateau, and continued low incidence of fracture. The benefit/risk profile for Denosumab in an ageing population of postmenopausal women remains favourable. BMD: bone mineral density; DMAb: denosumab Bone HG, et al. J Bone Miner Res. 2015; 30(Suppl 1):S471;LB1157

19 The good Evidence of reduced fracture risk compared to placebo Not renally excreted- advantages over BPs Easy to do- twice yearly s/c injection BMD continues to rise- no apparent plateau effect Cummings NEJM 2009;361: Papapoulous Ost. Int. 2015;26: Ferrari Ost. Int. 2015;26:

20 Cellulitis/infections More expensive that BPs Still get ONJ The bad? OK in renal impairment? Watch out for hypocalcaemia and those with very poor renal function Rapid drop-off effect if stopped or delayed

21 Treatment breaks- my view

22 Treatment breaks Long half-life of bisphosphonates results in continued effects after withdrawal A 3 year break off Zoledronate after 3 years of treatment results in a only small decrease in BMD After 2 years off alendronate and 1 year off risedronate, significant reductions in BMD are seen BMD falls and bone turnover markers increase rapidly after withdrawal of denosumab Compston. Clin Med 2016;16:s121-4, Miller et al. Bone 2008;43:222-9

23 Treatment breaks Who are they appropriate for and how long for? Who: Those with a response to treatment Those who have had 5 years or more of an oral bisphosphonate Those who have had 3 years or more of IV zoledronate Those who are younger How long for?: Alendronate - 2 years Risedronate - 1 year Zoledronate 3 years

24 Treatment breaks Evidence base is limited- use clinical judgement Who are they not for? Those with a prevalent vertebral fracture Those with T score at end of treatment still <-2.5 Elderly Those on steroids Those who have fractured on treatment

25 Any other questions?

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