Outline. Switching treatment. Evidence from randomized trials. The effects of switching 7/8/2016. When and for whom? Steven Cummings, MD

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1 Outline Switching treatment When and for whom? Steven Cummings, MD Focus on switching from alendronate or risedronate Evidence about the effects of switching on BMD Purposes of switching Symptoms Poor adherence or persistence Non response to treatment High risk despite treatment Based in part on principles of Goal directed Treatment Cummings, Cosman, Lewiecki EM. Goal directed treatment of osteoporosis. JBMR 2013;28:433 Evidence from randomized trials The effects of switching Systematic review of 11 trials Switching from alendronate or risedronate Effects on BMD No trials of the effect on fracture risk Eiken & Vestergaard. Osteoporosis Int :1 12 1

2 Effect of switching from alendronate Effect of switching from alendronate % change in L spine BMD ALN/Placebo % change in total hip BMD Eiken & Vestergaard. Osteoporosis Int :1 12 Conclusions from the review No trial had power to assess fracture risk No trial lasted >24 months; most 12 months Compared with continuing alendronate Switching to zoledronate maintained BMD Switching to denosumab increases BMD 1.5% (total hip) to 3% (spine) over 12 months Switching to teriparatide increases spine BMD 8 10% and total hip BMD 2% over 2 years Switching from alendronate to denosumab or zoledronate 643 women had received 2 years of oral bisphosphonate Hip or spine T 2.5 Randomized zoledronate annually or denosumab Q 6 mo for 12 months 15 fractures with zoledronate, 7 on denosumab (NS) Miller Cummings. JCEM 2016 (in press) 2

3 Switching because of symptoms About 20 30% of patients stop alendronate because of gastrointestinal symptoms These are often unrelated to treatment Consider persisting or a re challenge GI effects of alendronate ~4,000 women in FIT 2 Daily alendronate PBO (%) ALN (%) Any UGI symptom Abdominal Pain Esophagitis Esophageal ulcer Gastric ulcer Duodenal ulcer Bauer DC, Arch Intern Med 2000;160: Switching because of symptoms About 20 30% of patients stop alendronate because of gastrointestinal symptoms These are often unrelated to treatment Consider persisting or a re challenge Switch to parenteral treatment: zoledronate or denosumab Follow up Based on Goal directed Therapy Cummings, Cosman, Lewiecki EM. Goal directed treatment of osteoporosis. JBMR 2013;28:433 3

4 Principles of follow up for achievement of goals 1. Has the patient adhered to treatment? 2. Has the patient had a clinical fracture? 3. Has the patient developed a vertebral fracture? 4. Has the patient achieved her goal BMD? % fracture in 2 years Compliance (MP Ratio) Siris et al. Mayo Clin Proc 2006;81:1013 SC6 Adherence & persistence Routinely ask how much has the patient adhered to oral treatment? Aim for at least 80% adherence If poor adherence persists, consider zoledronate or denosumab Not a perfect solution: on average, patients started on denosumab receive only 3 doses SC2 Occurrence of a nonvertebral fracture A fracture during treatment indicates a 2 3 fold increased risk of another nonvertebral fracture 1 Consider switching to a more potent treatment However, little evidence that alternatives will further reduce the risk 1. Cosman et al JCEM

5 Slide 15 SC6 We distinguished between nonvert and vert. No data to suggest that switching tx would reduce risk of nonvert fx. The association of fx on treatment with future fx is not a strong as for vert fx. Steve Cummings, 9/7/2014 Slide 16 SC2 We distinguished between nonvert and vert. No data to suggest that switching tx would reduce risk of nonvert fx. The association of fx on treatment with future fx is not a strong as for vert fx. Steve Cummings, 9/7/2014

6 Principles of follow up for achievement of goals 1. Has the patient adhered to treatment? 2. Has the patient had a nonvertebral fracture? 3. Has the patient developed a new vertebral fracture? 4. Has she achieved a femoral neck T score 2.5? Obtain spine VFA or x ray Image at baseline Measure height at baseline Follow up every 1 2 years Measure height >3 cm loss indicates high risk of a new fracture Obtain VFA or x ray Or, repeat VFA or x ray at 3 5 years if considering changing treatment Cosman F et al OI 2014 Schousboe J et al. J Clin Densitometry 2006;9: Vertebral fracture during treatment During 3 years of zoledronate High risk of another vertebral fracture during treatment New vertebral fracture A vertebral fracture during treatment means a 5 fold risk of another vertebral fracture 1 Switch to a treatment with maximum efficacy to reduce vertebral fracture Zoledronate, denosumab, teriparatide: 65-70% Cosman, JCEM Cosman et al JCEM

7 Principles of follow up for achievement of goals 1. Has the patient adhered to treatment? 2. Has the patient had a clinical fracture? 3. Has the patient developed a vertebral fracture? 4. Has she achieved a femoral neck T score 2.5? If BMD goal is achieved If target T score > 2.5 has been achieved with a bisphosphonate Stop treatment Reassess BMD periodically SC3 If BMD goal is not achieved If femoral neck T score 2.5, continue the bisphosphonate If still far from a goal, T > 2.5, (T 3.0), consider switching to a treatment that will increase BMD more effectively Denosumab, teriparatide, or new treatments SC7 Has the patient responded to the treatment? If the patient has been adhering! 18% of women do not change, or lose, BMD at the femoral neck in year 1 10% lose BMD at the spine She may have lost more without treatment! 6

8 Slide 22 SC3 This is what we recommend in the report. We don't give an interval or raise monitoring with markers (for which there is no evidence of value) Steve Cummings, 9/7/2014 Slide 23 SC7 This is what we recommend in the report. We don't give an interval or raise monitoring with markers (for which there is no evidence of value) Steve Cummings, 9/7/2014

9 They responded! Those who lost had the greatest absolute reduction in fracture risk Summary: Indications for switching Consider switching to a drug with more effective for vertebral fracture: denosumab, zoledronate, PTH Consider switching if she If <80% adherence Develops a vertebral fracture Suffers a nonvertebral fracture? T score remains 3.0 despite ~3 years? Loses spine BMD despite adhering? 7

10 Summary: alternative treatments Lighter shade of grey means weaker evidence of benefit Indication Poor adherence Vertebral fracture on treatment Nonvertebral fracture on treatment T score 3.0 despite 2 3 years Loses spine BMD despite treatment Alternative Zoledronate or denosumab Teriparatide, denosumab, or zoledronate Consider denosumab or teriparatide Consider denosumab or teriparatide Consider denosumab or teriparatide 8

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