An Update on Osteoporosis Treatments

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1 An Update on Osteoporosis Treatments Dr Mike Stone University Hospital Llandough

2 Treatments for osteoporosis Calcium and vitamin D HRT Raloxifene Etidronate Alendronate Risedronate Ibandronate (oral and IV) IV Zoledronate Denosumab Calcitonin Calcitriol Teriparatide/1-84 PTH Strontium Ranelate Antiresorptives Anabolic >1 mode of action

3 Calcium and vitamin D Best treatment for frail elderly patients living in residential or nursing homes Reduces risk of hip and other fractures by 1/3 Chapuy et al NEJM 1992 Given as one tablet twice daily eg chewable calcium carbonate/vit D or swallowable caplets Liquid formulations too Soluble Suspension NB VIT D alone does not reduce the risk of hip fractures Cochrane review

4 Calcium and vitamin D Should usually be prescribed with other treatments eg bisphosphonates Sensible and what happened in major RCTs Vit D deficiency may impair BMD response (Fogelman 2009) Tailor calcium supplements to dietary intake Muscle and bone effects Reduced falls with combined calcium and vitamin D Pfeifer JBMR 2000, Osteoporos Int 2009

5 Calcium and cardiovascular disease BMJ metaanalyses Apparent increased risk of cardiovascular events Criticism of endpoint definition (see Prince et al JBMR 2011) Retrospective safety data analysis Mechanism for increased risk v unclear Evidence for decreased mortality in WHI group with highest calcium intake Calcium supplements lower mortality Arch Int Med 2011, Abrahamsen 2012 JCEM, Langsetmo 2013 JCEM

6 MHRA Oct 2011

7 Bisphosphonates Reduce bone turnover Increase bone density Remodelling space Secondary mineralisation Preserve bone structure Bone is stronger

8 Are all bisphosphonates the same? Potential determinants of efficacy Mineral affinity FPP synthase enzyme inhibition Convenience, tolerability, adherence Bioavailability IV v oral

9 Are all bisphosphonates the same? Effectiveness-ometer IV zoledronic acid IV ibandronic acid Alendronate, risedronate, ibandronate Etidronate

10 IV Zoledronate 5mg annually Pivotal Fracture Trial 7736 women aged years Overall RRR 70% vert #s Greater for women <70 41% hip #s 25% non-vert #s Nephrotoxicity signal Avoid if egfr <35 Ensure vitamin D replete 4 mg dose is generic NEJM 2007

11 » Horizon-RFT» Mean age 74.5 Mortality NEJM 2007 Lyles K et al

12 IV Zoledronic acid Post hoc analysis > 75 years Hip fractures >75 v younger Treatment by age group interaction p < 0.04 Boonen et al JAGS 2010

13 Oct 2010

14 Alendronic acid First line treatment - COST + NICE Generic Used for 19 years Reduces risk of vert, non-vert and hip fractures Very limited data in those > 80 y/o Endocrine reviews 2002

15 Alendronic acid BUT up to 60 % of patients will stop treatment by 6 months Cooper AL 2006 Cur Med Res

16 Risedronate Lower bone affinity and less potent than alendronic acid May enable greater access to osteocytes? Explains similar efficacy to more potent antiresorptives?? Fewer GI side effects Preferred treatment for GIOP Russell RGG OI 2009

17 Ibandronate Monthly 150 mg oral Convenience and tolerability (GI) Non-inferiority head to head with alendronate (BMD) IV every 3 months No renal toxicity Second line oral bisphosphonate

18 ALN stopped 9 months of s/c Teriparatide

19 Atypical femoral fractures 57 y/o lady Rheumatoid arthritis 7 years of ALN

20 Duration of treatment Bisphosphonates Harm v benefit Black NEJM 2012 Continuing and stopping Clear benefit for 5 years? Stop after 5 years if no vertebral fractures Maybe 10 years for those with vertebral fractures FLEX study Black 2006 JAMA GIOP??? Bone markers threshold Seeman 2009 OI

21 Denosumab (Prolia) Highly potent and rapidly acting antiresorptive 85% decrease in serum CTX after 3 days > alendronic acid (BMD and CTX) Human monoclonal Ab against RANK ligand (mimics OPG) 60 mg every 6 months s/c Licensed for Rx of PMO increased risk of fractures Men with Ca prostate treatment induced bone loss

22 Denosumab Binds RANK Ligand and Inhibits Osteoclast Formation, Function, and Survival CFU-GM Prefusion Osteoclast RANKL RANK OPG Denosumab Hormones Growth Factors Cytokines Osteoblasts Osteoclast Formation, Function, and Survival Inhibited Bone Formation Bone Resorption Inhibited Adapted from: Boyle WJ, et al. Nature. 2003;423: Amgen. All rights reserved. Do not copy or distribute.

23 Incidence at Month 36 (%) The Effect of Denosumab on Fracture Risks at 36 Months Phase 3: The FREEDOM Trial 9% 8% 7% 7.2% 68% P < % 20% P = 0.01 Placebo Denosumab 6% 6.5% 5% 4% 3% 2% 2.3% 40% P = % 0% 1.2% New Vertebral Nonvertebral Hip 0.7% Cummings SR, et al. N Engl J Med Aug 20;361(8):756-65

24 Incidence at Month 36 (%) The Effect of Denosumab on New Hip Fractures continues in the over 75s The Pivotal Phase 3 Trial Increased Risk Sub-analysis Placebo Denosumab 4 Post-Hoc Analysis Age 75 years 3 RRR = 62% P = RRR = 40% P = Overall Higher Risk of Hip Fracture *In a subset of higher risk patients with 2 of the following: (a) age > 70 years, (b) baseline BMD T-score 3.0 at lumbar spine, total hip, or femoral neck, (c) prevalent vertebral fracture at baseline In a subset of higher risk patients with femoral neck BMD T-score 2.5; In a subset of higher risk patients age 75 years FN = femoral neck Boonen S, et al. J Bone Miner Res. 2009;24(Suppl 1). Accessed September 13, Abstract A and oral presentation. Data on file, Amgen.

25 Percent Change Lumbar Spine BMD mean (95%CI) LS BMD continued to significantly increase in years 4 and 5 with long-term denosumab treatment * * * * * 13.7% LS BMD increase vs. Freedom baseline 4 * 2 * *p < from placebo and baseline 0 BL Exposure (Years) Papapoulos S, et al. Osteoporos Intl 2011(suppl 1) OC25 Denosumab long-term (N=2208) Placebo (N=2088)

26 BMD gains after 6 years of zoledronate therapy Black D, et al. American Society of Bone Mineral Research Annual Meeting, Toronto. 2010; abstract 5113

27 Denosumab BMD changes v fracture probability Freedom trial Miller PD ASBMR 2012

28 Denosumab differences from bisphosphonates Different pharmacokinetics Different mechanism of action? Better effect on cortical bone PTH surge with each dose Quick onset and quick offset of action Not nephrotoxic Licensed to egfr 15 but BEWARE hypocalcaemia Must be vit D replete

29 Percent Change (LS Mean ± SE) Percent Change (LS Mean ± SE) Denosumab Re-treatment and Changes in Lumbar Spine and Total Hip BMD Phase 2 Study in Women With Low BMD Lumbar Spine? IV ZOL Months Discontinued Treatment Re-treatment 60 mg Q6M Total Hip Months Placebo 30 mg Q3M 60 mg Q6M Discontinued Treatment Re-treatment 60 mg Q6M Adapted from Miller PD, et al. Bone. 2008;43:

30

31 Feb 2013

32 Primary prevention Second-line after oral bisphosphonates Lower BMD and clinical risk factors Secondary prevention Second-line after oral bisphosphonates

33 Use of Denosumab in Cardiff Second line to oral bisphosphonates Alternative to IV Zoledronate or Strontium ranelate No dose adjustment with renal impairment Beware hypocalcaemia Prevention of hip fracture in the elderly Compliance has been very good Very easy to administer Discussions ongoing with primary care First dose given in secondary care AWMSG (Wales) >1000 patients treated Cardiff bone service No serious side effects

34 Teriparatide Recombinant hpth (1-34) 20 µg/day Bone anabolic agent indicated for the treatment of osteoporosis Men + women + GIOP Teriparatide stimulates osteoblasts > osteoclasts Increases in skeletal mass Increases in markers of bone formation and resorption Improvement in bone structure Increases bone strength Reduces risk of vertebral and non-vertebral fractures Obermayer-Pietsch BM et al. J Bone Miner Res 2008; 23(10):

35 Effect of Teriparatide on Skeletal Architecture Patient treated with teriparatide 20µg Data from Jiang, J Bone Min Res 2003;18(11): Baseline Follow-up Jiang UCSF Female, age 65 Duration of therapy: 637 days (approx 21 months) BMD Change: Lumbar Spine: +7.4% (group mean = 9.7 ± 7.4%) Total Hip: +5.2% (group mean = 2.6 ± 4.9%)

36

37 Number of patients with new vertebral and nonvertebral fractures Alendronate Teriparatide p-value Vertebral radiographic 10/165 (6.1%) 1/171 (0.6%) Clinical vertebral 3/165 (1.8%) 0/171 (0%) 0.07 Nonvertebral 8/214 (3.7%) 12/214 (5.6%) Nonvertebral fragility 3/214 (1.4%) 5/214 (2.3%) Saag KG et al. N Eng J Med 2007; 357:

38 Use of Teriparatide For patients at higher risk of fracture from osteoporosis Esp if multiple fractures Very low BMD GIOP Poor or adverse response to antiresorptives Eg new fractures, decreasing BMDs, ONJ, atypical #s Sequential treatment after 5 years of antiresorptives Duration of treatment extended to 24 months Substantial rises in bone density final 6 months (Eurofors trial)

39

40 Strontium Ranelate The good news Fracture data good Specific data in > 80 y/o Different modality of treatment Alternative to antiresorptives Use after bisphosphonate Use in context of AFF or ONJ 10 years data Good for OA too

41 Strontium ranelate The bad news Restricted indications Severe osteoporosis Can not use other osteoporosis treatments Cardiovascular contraindications Safety update MHRA 2014 IHD Strokes Peripheral arterial disease Uncontrolled hypertension

42 Summary Good range of effective treatments Calcium and vit D for the frail elderly Choice of oral aminobisphosphonate dosing regimens Denosumab or IV bisphosphonates good alternative to oral Strontium Ranelate as a different modality of treatment Teriparatide for severe osteoporosis including GIOP and men Interesting new treatments on the way

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