Metabolic Bone Disease Related to Chronic Kidney Disease

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1 Metabolic Bone Disease Related to Chronic Kidney Disease Deborah Sellmeyer, MD Director, Johns Hopkins Metabolic Bone Center Dept of Medicine, Division of Endocrinology

2 Disclosure DSMB member for denosumab in glucocorticoid treated subjects study

3 GFR Stages of CKD GFR stages G1 G2 GFR (ml/min/1.73 m 2 ) 90 w/ evidence of renal damage 60 to 89 w/ evidence of renal damage G3a 45 to 59 G3b 30 to 44 Terms Normal or high Mildly decreased Mildly to moderately decreased Moderately to severely decreased G4 15 to 29 Severely decreased G5 <15 Kidney failure (add D if treated by dialysis) Add T if post-transplant

4 Definitions CKD-MBD: systemic disorder of mineral and bone metabolism due to CKD manifested by: Abnormalities of Ca, PO4, PTH, vitamin D Abnormalities of bone turnover, mineralization, volume, linear growth, strength Vascular or other soft tissue calcification Renal Osteodystrophy Alteration in bone morphology Quantified by histomorphometry on bone biopsy Measure of the skeletal component of CKD-MBD

5 Risk of fracture in patients with CKD ESRD patients on dialysis RR hip fracture 4.4 Transplant patients compared to those on dialysis RR hip fracture 1.34 in first year Risk falls approximately 1%/year and is equal within 3 years NHANES participants with egfr < 60 ml/min OR hip fracture 2.1 Patients with CKD have approximately 2X mortality after hip fracture

6 Interactions Between the Kidney and Mineral Metabolism Miller PD. Bone Res Dec 23;2:14044.

7 Pathogeneis of CKD-MBD Nephrogenic developmental programs reactivated by kidney injury Changes induced by nephrogenic processes promote vascular calcification and adversely effect skeleton Factors reactivated Wnt inhibitors Dkk1 Sclerostin Activin

8 Pathogeneis of CKD-MBD Loss of renal klotho Co-receptor for FGF-23 Regulates 1-alpha hydroxylase, PTH, FGF-23 Loss of klotho loss of regulation on FGF23 FGF-23 Produced by osteocytes and osteoblasts Promotes phosphate excretion Increase with renal injury One of earliest markers of CKD-MBD Stimulated by PTH

9 Pathogeneis of CKD-MBD Hyperphosphatemia Phosphate excretion impaired by loss of nephrons FGF-23 and PTH increase Loss of klotho limits FGF-23, PTH becomes main regulator Adaptive mechanism insufficient by Stages 4-5 Effects of hyperphosphatemia Stimulates vascular osteoblastic transition Suppresses 1-alpha hydroxylase Stimulates PTH Stimulates FGF-23 secretion

10 Pathogeneis of CKD-MBD Vitamin D deficiency 24 hydroxylase stimulated by FGF-23, increasing degradation of 25 OH vitamin D and 1,25 OH vitamin D 1-alpha hydroxylase inhibited by FGF-23, phosphorus Decreased intestinal calcium absorption Stimulation of PTH Hyperparathyroidism Develop nodular hyperplasia of parathyroid glands Affects both osteoblasts and osteoclasts, increases bone resorption 60% Stage 3 patients have hyperparathyroidism Skeletal resistance due to downregulation of PTH receptors in bone High PTH associated with increased mortality, low PTH associated with adynamic bone disease

11 Renal Osteodystrophy: TMV Categorization Normally Mineralized Bone Unmineralized Bone Normal Bone Volume Low Bone Volume Normal Bone Volume Low Bone Volume High Bone Volume Normal Bone Osteoporosis Osteomalacia Adynamic Bone Hyperparathyroid Torres PU, et. al. Semin Nephrol Nov;34(6):612

12 Tetracycline labeled bone biopsy Two courses oral tetracycline separated by ~10 days binds to newly formed bone at the bone/osteoid interface visible as a linear fluorescence Phone: mml@mayo.edu

13 Histomorphometry of Renal Osteodystrophy Normal bone Hyperparathyroidism Osteomalacia Torres PU, et. al. Semin Nephrol Nov;34(6):612

14 Bone histology in dialysis patients Low Turnover (57%) Normal Turnover (16%) High Turnover (24%) Mineralization Defect (3%) 600 HD, 30 PD patients Turnover Black (n=87) 43% high turnover 32% low turnover White (n=543) 18% high turnover 62% low turnover Volume Black (n=87) 60% high volume 15% low volume White (n=543) 33% high volume 35% low volume Malluche HH, Mawad HW, Monier-Faugere MC. J Bone Miner Res Jun;26(6):1368.

15 Bone histology in CKD-MBD 148 CKD patients in Brazil Age % male Low (N=123) Turnover Mineralization Volume High (N=25) Normal (N=117 Abnormal (N=31) Low (N=66) Normal (N=82) Stages 2 & 3 (%) Stage 4 (%) Stage 5D (%) Graciolli FG, et. al. Kidney Int Jun;91(6):

16 Bone histology in CKD-MBD 132 CKD patients in Germany 96 Stage 5D Age years 78 men, 54 women 47% high turnover Stages % high turnover Stage 5D Lehmann G, et al. Clin Nephrol Oct;70(4):

17 DXA in patients with CKD HABC Cohort N=3075 Avg age = years Approx equal genders and black/white Non-spine fractures through Year 11 Unadjusted Adj for age, race, sex, and BMI Hazard Ratio (95% Confidence Interval) Overall No CKD CKD 2.85 (2.23, 3.64) 1.77 (1.35, 2.32) 2.97 (2.24, 3.93) 1.64 (1.20, 2.25) 2.53 (1.55, 4.13) 2.10 (1.24, 3.59) P Value for CKD Osteoporosis Interaction Clin J Am Soc Nephrol 7: , July, 2012

18 FRAX in patients with CKD CaMOS Cohort N=2107 Mean age years 71% women 5 year observed MOF risk =5.3%, FRAX = 6.4% AUC (95% confidence interval) for incident Major Osteoporotic Fracture prediction by egfr egfr (ml/min per 1.73 m 2 ) <60 >60 Difference P Value FRAX with BMD 0.69 (0.54, 0.83) 0.76 (0.70, 0.82) (-0.23, 0.09) 0.38 FRAX w/o BMD 0.65 (0.52, 0.79) 0.74 (0.67, 0.81) (-0.24, 0.06) 0.25 Clin J Am Soc Nephrol 10: , April, 2015

19 Bone biomarkers in patients with CKD Sclerostin low level predicts high turnover better than PTH high level predicts low turnover better than PTH Not commercially available Resorption markers Collagen cross links (CTX) are renally cleared and not helpful Tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) product of osteoclast, not renally cleared, shows promise as marker, not commercially available Formation markers Osteocalcin of limited utility due to fragments, retention, carboxylated and uncarboxylated forms Bone specific alk phos Low BSAP PPV between % for low turnover

20 Bone biomarkers in patients with CKD Cutoff value Sensitivity PPV CKD Stages 3/4 PTH (pg/ml) BsAP (µg/l) CKD Stage 5 PTH (pg/ml) BsAP (µg/l) CKD patients in Germany 96 Stage 5D Age years 78 men, 54 women 47% high turnover Stages % high turnover Stage 5D Lehmann G, et al. Clin Nephrol Oct;70(4):

21 Bone biomarkers in patients with CKD Low vs. Non-low turnover Best cutoff value AUC PTH (pg/ml) BsAP (U/L) High vs. Non-high turnover PTH (pg/ml) BsAP (U/L) dialysis patients in Brazil, Venezuela, Portugal, Turkey Age 50 years, 45% women 59% low turnover 24% normal turnover 17% high turnover Sprague SM, et. al. Am J Kidney Dis Apr;67(4):

22 Bone biomarkers in patients with CKD Low turnover: PTH < 150 pg/ml, sensitivity 69% BSAP <12.9 ng/ml, sensitivity 100% High turnover: PTH >300 pg/ml; sensitivity 58% BSAP >20 ng/ml excludes adynamic bone, especially w/ PTH >200 pg/ml Sisti, et. al. Journal of Clinical & Translational Endocrinology 5 (2016) 32 35

23 When to consider a biopsy Trends in PTH inconsistent Unexplained fractures Refractory hypercalcemia Suspected osteomalacia Atypical response to PTH lowering therapies Progressive decline in BMD despite therapy

24 Laboratory Monitoring Ca and PO4 PTH Alkaline phosphatase G3a-G3b 6-12 months Based on initial level and CKD progression G4 3-6 months 6-12 months 12 months G5, G5D 1-3 months 3-6 months 12 months, more freq if PTH Monitor more frequently in setting of abnormalities, interventions, CKD progression Measure and correct vitamin D deficiency Treat based on trends and all CKD-MBD assessments Use individual measurements of Ca and Phos rather than product -

25 Phosphorus Recommendations for CKD G3a-G5D lower phosphorus levels toward normal range decisions about phosphate lowering therapy should be based on progressively or persistently elevated phosphate Both high and low phosphorus associated with mortality Non-calcium phosphate binders associated with mortality compared to calcium; unclear benefit if phos wnl Phosphate binders associated with CAC possibly due to calcium acetate non calcium binders not better than placebo Limit calcium containing binders balance studies suggest 1000 mg/day calcium

26 Phosphorus: Dietary restriction Data lacking on effectiveness Major sources of phosphates Naturally occurring in raw foods Added to processed foods Dietary supplements/medications Food contains organic phos Animal: 40-60% absorbed Plant: 20-50% absorbed due to phytates Additives contain inorganic phos more readily absorbed Ensure adequate protein

27 Treatment of PTH levels Optimal PTH level CKD 3a-5 is not known; CKD 5D: goal PTH 2-9 x ULN Patients with persistently or progressively elevated PTH evaluate for modifiable factors: vitamin D, phos, calcium Suggest vitamin D analogues not be routinely used in CKD 3-5 Analogues effective for PTH 2 RCTs showing no effect on LVH risk hypercalcemia,? oversuppression PTH Reserve vitamin D analogues for CKD G4-G5, 5D with severe and progressive hyperparathyroidism Calcimimetics, calcitriol, vitamin D analogues all acceptable Parathyroidectomy CKD G3a-5D for severe hyperparathyroidism not responsive to medical therapy

28 Calcium Current recommendation: Avoid hypercalcemia Both hypo and hypercalcemia associated with mortality Treatment with cinacalcet did not alter CV events or mortality; associated with hypocalcemia, GI AEs Possible benefit in individuals >65 years EVOLVE Trial Investigators. N Engl J Med Dec 27;367(26):

29 Transplant Lower BMD by DXA associated with fracture risk High rate of bone loss first months Glucocorticoid sparing regimen may be reducing posttransplant fracture incidence CKD G1T-G5T, consider BMD by DXA Data limited to first 12 months after transplant Treat with vitamin D, vitamin D analogues, and/or antiresorptive agents as indicated if egfr >30 ml/min Consider bone biopsy Bisphosphonates increase BMD after transplant 7.4% at spine 6% femoral neck Toth-Manikowski SM, et. al. Clin Transplant Sep;30(9):

30 % Changes in bone histomorphometry after transplant p<0.01 p<0.05 p< paired biopsies Age years HD months bx days after tx Osteoid surface Osteoblast surface Pre-transplant Fibrosis Pre-tx Post-tx P-value PTH (pg/ml) <0.05 Phos (mg/dl) <0.01 BsAP (U/L) NS Post-transplant Rojas E, et. al. Kidney Int May;63(5):

31 Long term changes after transplant 25 men with normal renal function after transplant years after transplant Ca, Phos, alk phos, 1,25 OH D, urine Ca normal PTH elevated in 11, normal in 14 Histomorphometry: resorption, osteoid volume, osteoid surface Bone formation rate and mineralization surface low, mineralization time delayed Improved with time, approaching normal after 10 yrs Carlini RG, et. al. Am J Kidney Dis Jul;36(1):160-6

32 Laboratory Monitoring Monitor Ca, Phos Weekly until stable Ca and PO4 PTH Alkaline phosphatase G1T-G3bT 6-12 months Once, repeat based on initial level and CKD progression G4T 3-6 months 6-12 months G5T 1-3 months 3-6 monhts G3a-G5T 12 months, more freq if PTH Monitor more frequently in setting of abnormalities, interventions, CKD progression Treat as for patients with CKD G3a-G5 Measure and correct vitamin D deficiency

33 Osteoporosis medications CKD G1-G2 with osteoporosis and/or high fracture risk, manage as for general population CKD G3a-3b with normal PTH and osteoporosis and/or high fracture risk, treat as for the general population CKD G3a-G5D with biochemical abnormalities of CKD- MBD and low BMD and/or fragility fractures take into acct magnitude and reversibility of biochemical changes, progression of CKD consider bone biopsy Bisphosphonate labeling rec CrCl > ml/min Denosumab no restrictions

34 Percent (%) of patients Pooled Analysis of Nine Risedronate Trials % p= % P< % P< <30 ml/min N= ml/min N= ml/min N=3086 Baseline Renal Impairment (CrCl in ml/min) Miller PD, et. al. J Bone Miner Res Dec;20(12):

35 Fracture risk with alendronate by egfr (N=6458) egfr OR (95% CI Clinical fractures <45 ml/min 0.78 ( ) >45 ml/min 0.81 ( ) All fractures <45 ml/min 0.72 ( ) >45 ml/min 0.50 ( ) p for interaction No increased risk of renal adverse events. Jamal SA, et. al. J Bone Miner Res Apr;22(4):503-8.

36 Zoledronic acid Required egfr>30 ml/min No differences in effects on renal function compared to placebo Must be infused slowly (> 15 minutes) Renal toxicity related to peak drug level Labeling: contraindicated with egfr<35 ml/min Transient serum Cr >0.5 mg/dl more freq in zol than placebo (1.3% vs. 0.4%, p=0.001 More common with egfr ml/min No long term renal sequelae Boonen S, et. al. Kidney Int Sep;74(5):641-8.

37 Effect of denosumab on fracture by level of renal function (OR, 95% CI) Stage 4 (N=73) Stage 3 (N=2817) Stage 2 (N=4069) Stage 1 (N=842) Vertebral 0.31 ( ) 0.38 ( ) 0.23 ( ) 0.33 ( ) Non-vertebral 0.51 ( ) 0.88 ( ) 0.69 ( ) 0.89 ( ) 7808 postmenopausal women ages years No significant treatment by subgroup interaction No differences in AEs No increase vascular calcification by x-ray Increased risk of hypocalcemia in patients with renal insufficiency Jamal SA, et. al. J Bone Miner Res Aug;26(8):

38 Effect of raloxifene on incident vertebral fracture by egfr Overall cohort egfr <45 ml/min egfr ml/min egfr > 60 OR (95% CI) 0.57 ( ) 0.74 ( ) 0.54 ( ) 0.60 ( ) P for interaction postmenopausal women Age years 96% Caucasian Ishani A, et al. J Am Soc Nephrol Jul;19(7):

39 Percent Change in BMD Percent Change in BMD Effects of teriparatide on BMD by level of renal function (N=1637) Lumbar Spine (18 months) * * * * * * Femoral Neck BMD (12 months) * * * * 0-5 Placebo Teriparatide 20 mcg/day Teriparatide 40 mcg/day > CrCl (ml/min > CrCl (ml/min Miller PD, et. al. Osteoporos Int Jan;18(1):59-68.

40 Summary CKD Stages 1-2 Address skeletal health as in the general population CKD Stages 3a-3b Address skeletal health as in the general population Monitor for biochemical abnormalities of CKD-MBD CKD Stage 4 Monitor for biochemical abnormalities of CKD-MBD Treat progressive, persistent PTH elevations Total calcium intake 1000 mg/day Decrease phos toward or into normal range Obtain DXA as clinically indicated Limited data on osteoporosis interventions Consider bone biopsy before treatment

41 Summary CKD Stage 5 and 5D Assess and treat biochemical abnormalities of CKD-MBD Total calcium intake 1000 mg/day Bring phos down toward or into normal range PTH goal 2-9x ULN Stage 5D Use PTH lowering agents as needed Obtain DXA as clinically indicated No data on osteoporosis pharmacologic agents Consider bone biopsy before treatment Transplant CKD G1T-G5T, consider BMD by DXA Data limited to first 12 months after transplant Treat with vitamin D, vitamin D analogues, and/or antiresorptive agents as indicated if egfr >30 ml/min Consider bone biopsy before treatment

42 Questions?

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