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Abstract: TH-PO1191

A Precision Medicine Approach to Treatment of Osteoporosis in CKD-5D

Session Information

Category: Bone and Mineral Metabolism

Authors

  • Malluche, Hartmut H., University of Kentucky, Lexington, Kentucky, United States
  • Lima, Florence, University of Kentucky, Lexington, Kentucky, United States
  • Hellman, Katelyn M, University of Kentucky, Lexington, Kentucky, United States
  • Spach, Tara L, University of Kentucky, Lexington, Kentucky, United States
  • Chen, Jin, University of Kentucky, Lexington, Kentucky, United States
  • Davenport, Daniel, University of Kentucky, Lexington, Kentucky, United States
Background

This prospective stage II proof-of-concept randomized controlled study uses different treatments for osteoporosis in low vs. non-low bone turnover (Low TO vs. Non-low TO) CKD-5D patients.

Methods

In 36 dialysis clinics across Kentucky, 96 CKD-5D patients with established Low TO and Non-low TO osteoporosis were enrolled. Low TO was determined by serum measurements of PTH, PTH ratio, and TRAP-5b below race-specific normal ranges histologically validated by our laboratory. In Low TO patients, teriparatide combined with cinacalcet was given to stimulate bone formation. In Non-low TO patients, alendronate was administered to reduce bone resorption. The primary endpoint was 1-year change in bone mineral density (BMD) measured by QCT.

Results

Patient status is shown in the Table. In Low TO patients, change in Total Hip BMD demonstrated a positive effect of treatment (Treatment: 12.6 mg/cm3 [SE 5.8] n=8; Control: -14.1 [SE 12.7] n=8; p=.076). The mortality rate was 17% (10/60) in Non-low TO patients with no deaths in Low TO patients (Figure, p=.003). Only two Non-low TO control patients survived to complete the study, thus group comparisons are not yet feasible; Non-low TO treated patients had bone loss of only 4.0 mg/cm3. In Low TO patients identified through blood tests, teriparatide has a positive effect on reversing bone loss in CKD-5D.

Conclusion

This study demonstrates better survival in Low TO vs. Non-low TO CKD-5D osteoporotics; supporting the precision medicine approach.

 Non-low TurnoverLow TurnoverTotal Both Arms
Ongoing in Sudyn=2440%n=1850%n=4253%
Transplanted/withdrewn=1525%n=26%n=1714%
Deathn=1017%n=00%n=1010%
Completedn=1118%n=1616%n=2727%
Totaln=60100%n=36100%n=96100%

Funding

  • NIDDK Support