Osteoporosis Medications: A Case-Based Discussion. Laila S. Tabatabai, MD August 5, 2017

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1 Osteoporosis Medications: A Case-Based Discussion Laila S. Tabatabai, MD August 5, 2017

2 Disclosures Eli Lilly Radius

3 Objectives Determine which patients with low bone density require treatment, along with optimal duration of treatment Select antiresorptive agents based on the patient's individual characteristics and preferences Recognize the benefits of anabolic agents in specific subpopulations of osteoporosis patients

4 Objectives Determine which patients with low bone density require treatment, along with optimal duration of treatment Select antiresorptive agents based on the patient's individual characteristics and preferences Recognize the benefits of anabolic agents in specific subpopulations of osteoporosis patients

5 Case 1 Gemma, a 52-year-old Caucasian woman presents to her primary care provider (PCP), for her annual physical examination She is 5'2" and weighs 103 lb. BMI 18.8 Gemma reports irregular menses and occasional hot flashes. She is not on HRT She says that she has a couple of glasses of wine most weekends and smokes 1-2 cigarettes daily She does not regularly take any prescription medication. Uses NSAIDS as needed for aches and pains, usually in the evening She takes a daily multivitamin supplement. She avoids dairy foods due to GI symptoms

6 The best next step in evaluation would be: No recommendation at this time Make a note on her file to monitor her for bone loss at her next annual exam Order a DXA scan Recommend calcium supplementation

7 The best next step in evaluation would be: No recommendation at this time Make a note on her file to monitor her for bone loss at her next annual exam Order a DXA scan Recommend calcium supplementation

8 Gemma s risk factors for Osteoporosis Caucasian race Perimenopause/post-menopause accelerated bone loss Low BMI, small frame Smoking Calcium-deficient diet

9 Risk factors for Osteoporosis Caucasian or Asian race/ethnicity Female sex History of fragility fracture Parental hip fracture Long-term steroid use (greater than 5 mg prednisone for 3 weeks or longer) 3 or more alcoholic beverages daily Tobacco use Secondary causes (type 1 DM, rheumatoid arthritis, chronic malnutrition, longstanding hyperthyroidism, hypogonadism, chronic liver disease)

10 Indications for Evaluation of BMD Fragility fracture (fall from standing height) Loss of height (>2 inches) Visible dorsal kyphosis Radiographic osteopenia, vertebral compression fracture

11 DXA DXA scan reveals that Gemma has a L1-L4 T-score of -1.5, right femoral neck T-score -2.2, right total hip T-score What is the best next step in assessing her fracture risk? No further assessment is necessary, the DXA scan gives all the information needed Use the FRAX fracture risk assessment tool Obtain a x-rays of the entire skeleton to rule out all possible occult fractures Ask Gemma her back pain level from 0-10 out of 10 while she stands, sits, and then lies supine on the examination, to assess for vertebral compression fracture

12 DXA DXA scan reveals that Gemma has a L1-L4 T-score of -1.5, right femoral neck T-score -2.2, right total hip T-score What is the best next step in assessing her fracture risk? No further assessment is necessary, the DXA scan gives all the information needed Use the FRAX fracture risk assessment tool Obtain a x-rays of the entire skeleton to rule out all possible fractures Ask Gemma to rate her back pain level from 0-10 out of 10 while she stands, sits, and then lies supine on the examination, to assess for vertebral compression fracture

13 FRAX (WHO Fracture Risk Assessment Tool)

14 Risk Factors

15 Risk Assessment

16 FRAX Threshold To Treat 10-year risk of major osteoporotic fracture > 20% 10-year risk of hip fracture > 3%

17 Risk Assessment

18 Trabecular Bone Score (TBS) Derived from the texture of the DXA image and has been shown to be related to bone microarchitecture and fracture risk. Computed from the antero-posterior spine DXA examination file by a software (TBS insight) The lumbar spine texture analysis using TBS is a risk factor for osteoporotic fracture. The predictive ability of TBS is independent of FRAX clinical risk factors and femoral neck BMD. The calculated probabilities of fracture have been shown to be more accurate when computed including TBS.

19 FRAX Limitations Lacks dose-response effects (years of smoking, amount of glucocorticoid exposure, number of fractures, etc.) Does not accommodate all known risk factors (falls, biochemical markers, etc.) Only applicable to untreated patients Limited country models available Does not replace clinical judgment

20 Interactive use FRAX calculator

21 Objectives Determine which patients with low bone density require treatment, along with optimal duration of treatment Select antiresorptive agents based on the patient's individual characteristics and preferences Recognize the benefits of anabolic agents in specific subpopulations of osteoporosis patients

22 Helga 68 y.o German lady with active tobacco use, COPD with longterm steroid use, GERD with Barrett s esophagus under annual surveillance Tells you she tried the Sally Field drug and hated it No fractures, no significant height loss, no parental hip fracture Takes no calcium or vitamin D supplements. Makes her own goat cheese and kefir has 3-4 servings of dairy foods daily DXA: lowest T-score -2.6 at R femoral neck, FRAX: 10-yr major fracture risk 14% and 10-yr hip fracture risk 7.3% Labs: Creatinine 1.4, GFR 32, 25-hydroxyvitamin D 27, PTH 78, calcium 9.1. SPEP nl, celiac panel neg.

23 Helga Does she need treatment? Which medication should you choose? What concerns do you have?

24 FDA-Approved Medications Drug PMO GIO Men Prevention Treatment Prevention Treatment Estrogen Raloxifene Calcitonin Alendronate Risedronate Ibandronate Zoledronic acid Denosumab Teriparatide PMO: post-menopausal osteoporosis GIO: glucocorticoid-induced osteoporosis

25 FDA-Approved Medications Drug Fracture Efficacy Possible Side Effects Spine Hip Estrogen (PO, TD) Stroke, CV, DVT, breast Ca Raloxifene (PO) DVT Calcitonin (SQ, nasal) Nasal irritation (nasal) Alendronate (PO) ONJ, AFF, GI Risedronate (PO) ONJ, AFF, GI Ibandronate (PO, IV) ONJ, AFF, GI (PO) Zoledronic acid (IV) ONJ, AFF, renal Denosumab (SQ) Immune, ONJ, AFF Teriparatide (SQ) Hypercalcemia, GI ONJ: osteonecrosis of the jaw AFF: atypical femoral fracture

26 Denosumab Biologic monoclonal antibody Mechanism Inhibits receptor activated nuclear factor kb Prevents osteoclast formation Short half life, not bound to skeleton Subcutaneous every six months

27 Denosumab Advantages Does not persist in skeleton, reversible Not cleared by kidney: can use with creatinine clearance below 30 ml/min Fracture efficacy spine, hip, non-vertebral May help adherence in some patients Disadvantages Immune effects: infections may be increased Marked suppression of bone turnover Long term safety issues: ONJ, atypical fractures Hypocalemia (CKD pts, prostate cancer w/ bone mets) Increase in rebound vertebral fracture rate

28 Denosumab: 8 Year Data Extension study: All on denosumab at 48 months Percent Change from Baseline Changes at Lumbar Spine Months Denosumab Placebo McClung MR, Lewiecki EM, Geller ML, Bolognese MA, Peacock M, Weinstein RL et al. Osteoporos Int 2013; 24:

29 Denosumab: 8 Year Data Extension study: All on denosumab at 48 months Percent Change from Baseline Changes at Hip Denosumab Placebo McClung MR, Lewiecki EM, Geller ML, Bolognese MA, Peacock M, Weinstein RL et al. Osteoporos Int 2013; 24:

30 Formulate Tailored Treatment Plans Oral bisphosphonates PROS cheap, effective (osteoporotic fracture risk reduction ~50%), no significant rebound with discontinuation CONS GI side effects (even in patients without GERD/gastritis/ulcers), AFF and ONJ with longterm/uninterrupted use, requires bisphosphonate holiday, lack of long-term adherence, Up to 50% of patients on oral bisphosphonates abandon therapy within the 1 st year 1 12-month persistence rates were 47.5% for monthly ibandronate and 30.4% for weekly bisphosphonates 2 Compliance (MPR, medication possession ratio) was significantly higher in the monthly cohort (MPR=85%) than in the weekly cohort (MPR=79%) 2 1. Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Huybrechts KF et al. Bone June;38(6): Adherence to monthly and weekly oral bisphosphonates in women with osteoporosis. Cotte FE et al. Osteoporos Int (2010) 21:

31 Formulate Tailored Treatment Plans Parenteral Anti-resorptives (IV zoledronic acid, SC denosumab) PROS improved adherence, highly potent, effective (osteoporotic fracture risk reduction ~50-70%), no significant GI side effects CON ONJ, AFF with long-term/uninterrupted use, significant acute phase reaction with IV zoledronic acid (usually 1 st dose only) CON significant increase in rebound vertebral fracture rate with discontinuation of denosumab 1,2 absent microdamage repair during therapy and excess reactivation of osteoclasts, rapid bone resorption Rebound-associated vertebral fractures (RVF) - multiple new clinical vertebral fractures, associated with either no or low trauma, in the context of high bone turnover and rapid loss of lumbar spine bone mineral density (BMD) occurring within 3 to 12 months after discontinuation of denosumab 1. Rebound-associated vertebral fractures after discontinuation of denosumab-from clinic and biomechanics. Popp AW et al. Osteoporosis Int 2016 May;27(5): Severe Rebound-Associated Vertebral Fractures After Denosumab Discontinuation: 9 Clinical Cases Report Lamy O et al. JCEM 2017 Feb;102(2)

32 When selecting a medication for treatment of osteoporosis, consider this Fracture risk Comorbidities Contraindications (relative and absolute) Patient preference Adherence Duration of treatment

33 Helga 68 y.o German lady with active tobacco use, COPD with longterm steroid use, GERD with Barrett s esophagus under annual surveillance Tells you she tried the Sally Field drug and hated it No fractures, no significant height loss, no parental hip fracture Takes no calcium or vitamin D supplements. Makes her own goat cheese and kefir has 3-4 servings of dairy foods daily DXA: lowest T-score -2.6 at L1-L4, FRAX: 10-yr major fracture risk 28% and 10-yr hip fracture risk 4.1% Labs: Creatinine 1.4, GFR 32, 25-hydroxyvitamin D 27, PTH 78, calcium 9.1. SPEP nl, celiac panel neg.

34 Helga Does she need treatment? Which medication should you choose? What concerns do you have?

35 Helga Does she need treatment? YES Which medication should you choose? What concerns do you have?

36 Helga Does she need treatment? YES Which medication should you choose? DENOSUMAB What concerns do you have?

37 Helga Does she need treatment? YES Which medication should you choose? DENOSUMAB What concerns do you have? Renal disease and vitamin D deficiency risk of hypocalcemia Adherence to therapy rebound vertebral fracture risk

38 Objectives Determine which patients with low bone density require treatment, along with optimal duration of treatment Select antiresorptive agents based on the patient's individual characteristics and preferences Recognize the benefits of anabolic agents in specific subpopulations of osteoporosis patients

39 Osteoporosis Treatment: Anabolic Agents

40 Osteoporosis Treatment: Anabolic Agents Mainstay of treatment for patients who have suffered a fragility/osteoporotic/pathological fracture (non-malignancy) Should be first-line treatment in fracture patients without contraindications to anabolic therapy Only treatment available for patients with atypical fractures related to long-term bisphosphonate use

41 Osteoporosis Treatment: Anabolic Agents Only 22% of fragility fracture patients receive treatment for osteoporosis 1 Fracture risk is elevated for several years after the initial fracture: 10% in 1 st year, 18% in 2 nd year 2 and stays elevated for 15 years 3 Almost 2/3 of women age 50+ with hip fracture were not started on osteoporosis treatment within 12 months of discharge 4 1. Solomon DH et al. Am J Med (5): Balasubramanian et al, JBMR, 2016; 31(suppl 1). 3. Van Geel TA et al., Ann Rheum Dis, 2009;68: Solomom DH et al. JBMR :

42

43 Teriparatide Summary of Effects 1 : Increase in spine BMD of 10-14%, 96% of postmenopausal women showed an increase Increase in femoral neck BMD 3-5% Reduced risk of vertebral fractures by up to 69% Reduced risk of nonvertebral fracture by up to 54% 1. Neer R et al. NEJM. 2001; 344:1434.

44 Teriparatide Teriparatide is much more efficacious at increasing lumbar spine bone density than hip bone density No early separation in incidence of nonvertebral fractures in teriparatide-treated groups versus placebo-treated groups In clinical use for over 15 years

45 Novel Osteoporosis Agents: Abaloparatide Only the 2 nd anabolic agent approved for treatment of osteoporosis Approved on 4/28/17 Indication: for treatment of postmenopausal women with a recent osteoporotic fracture Designed by insertion of residues into the PTH related peptide amino-terminal fragment between residues 22 and 34.

46 Novel Osteoporosis Agents: Abaloparatide Resulting peptide is a selective activator of the PTH type 1 receptor pathway, more anabolic effects & less bone resorption than teriparatide. High affinity binding to the bone formation configuration of the PTH type 1 receptor, and lower affinity binding to the resorptive configuration. This results in less calcium mobilization and net greater anabolic effect than PTH (teriparatide) or PTHrp.

47 Novel Osteoporosis Agents: Abaloparatide Phase 2 study: abaloparatide produces rapid bone mineral density increases at the lumbar spine and at primarily cortical skeletal sites, including the hip. Phase 3 results from the ACTIVE trial (Abaloparatide Comparator Trial In Vertebral Endpoints): abaloparatide treatment for 18 months reduced new vertebral fractures by 86% and nonvertebral fractures by 43%, with rapid separation in nonvertebral fracture risk between the abaloparatide and placebo groups.

48 Novel Osteoporosis Agents: Abaloparatide Safety concerns: As with teriparatide, use of abaloparatide is associated with a dose-dependent increase in osteosarcoma in rats This effect was observed at doses between 4 28 the exposure in humans using the 80 mcg dose Use is not recommended in patients at increased risk for osteosarcoma, including Paget s disease, those with unexplained elevations in alkaline phosphatase, open epiphyses, prior skeletal irradiation (external beam or implant), skeletal malignancies. Boxed warning is identical to warning on teriparatide

49 Lumbar spine Total hip Femoral neck Mayo Clinic Proceedings , DOI: ( /j.mayocp ) Copyright 2016 Mayo Foundation for Medical Education and Research

50 Teriparatide or Abaloparatide? Cost Approval BMD site of concern ACTIVE data: Early increase in s-pinp and the less prominent increase in s-ctx with abaloparatide compared with teriparatide 1 1. Miller P et al. JAMA. 2016;316(7):

51 Teriparatide or Abaloparatide? Despite being lower in the abaloparatide group vs the teriparatide group, bone formation (s-pinp), still remained 50% above baseline in the abaloparatide group at 18 months. Abaloparatide: It may be that smaller increases in formation coupled with a lesser increase in markers of bone resorption, are consistent with early increases in BMD and earlier fracture protection. Further research is needed Miller P et al. JAMA. 2016;316(7):

52 AACE Clinical Practice Guideline for the Diagnosis and Treatment of Postmenopausal Osteoporosis

53 Novel Osteoporosis Agents: Romosozumab Developed by Amgen. Awaiting approval. Sclerostin deficiency leads to sclerostosis (high bone mass and resistance to fracture) Sclerostin is secreted by osteocytes, inhibits Wnt signaling, thus reducing osteoblast activity MoA: Monoclonal antibody that binds and inhibits sclerostin Increases bone formation and reduces bone resorption ( uncoupling effect )

54 Novel Osteoporosis Agents: Romosozumab Phase 3 study safety data: Increase in positively-adjudicated serious cardiovascular adverse events in romosozumab group 2.5% of romosozumab patients suffered cardiovascular SAE versus 1.9% in the alendronate group.

55 References Camacho PM, Petak SM, Binkley N, Clarke BL, Harris ST, Hurley DL, Kleerekoper M, Lewiecki EM, Miller PD, Narula HS, Pessah-Pollack R, Tangpricha V, Wimalawansa SJ, Watts NB. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis Endocrine Practice Sep 2; 22(Suppl 4):1-42. Black DM, Rosen CJ. Clinical Practice. Postmenopausal Osteoporosis. N Engl J Med 2016 Jan 21:374(3): Lewiecki EM, Miller PD, Harris ST, Bauer DC, Davison KS, Dian L, Hanley DA, McClung MR, Yuen CK, Kendler DL. Understanding and communicating the benefits and risks of denosumab, raloxifene, and teriparatide for the treatment of osteoporosis. J Clin Densitom Oct-Dec; 17(4): Adler RA, El-Hajj Fuleihan G, Bauer DC, Camacho PM, Clarke BL, Clines GA, Compston JE, Drake MT, Edwards BJ, Favus MJ, Greenspan SL, McKinney R Jr, Pignolo RJ, Sellmeyer DE. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res Jan;31(1):16-35.

56 Medicine is only for those who cannot imagine doing anything else. Luanda Grazette, MD Keck School of Medicine, USC

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