Abstract: TH-PO1191
A Precision Medicine Approach to Treatment of Osteoporosis in CKD-5D
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- No subcategory defined
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 Turnover | Low Turnover | Total Both Arms | ||||
Ongoing in Sudy | n=24 | 40% | n=18 | 50% | n=42 | 53% |
Transplanted/withdrew | n=15 | 25% | n=2 | 6% | n=17 | 14% |
Death | n=10 | 17% | n=0 | 0% | n=10 | 10% |
Completed | n=11 | 18% | n=16 | 16% | n=27 | 27% |
Total | n=60 | 100% | n=36 | 100% | n=96 | 100% |
Funding
- NIDDK Support