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Abstract: TH-OR11

Treatment of Osteoporosis in CKD5D Patients Based on Bone Turnover: A Randomized Controlled Trial Showing Better Survival in Patients with Non-High Turnover

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Malluche, Hartmut H., University of Kentucky Medical Center, Lexington, Kentucky, United States
  • Lima, Florence, University of Kentucky Medical Center, Lexington, Kentucky, United States
  • Faugere, Marie-Claude M., University of Kentucky Medical Center, Lexington, Kentucky, United States
  • Davenport, Daniel, University of Kentucky Medical Center, Lexington, Kentucky, United States
Background

Bone turnover in osteoporotic CKD5D patients (pts.) may be elevated (HTO), normal or low (Non-high turnover, NHTO). There is no information on a tailored approach to treatment based on bone turnover. In HTO, characterized by excessive resorption, it makes sense to use antiresorbers, while they should be avoided in NHTO.

Methods

119 adult CKD-5D pts. with DXA t-scores < -1.0 were enrolled into this 12 month trial. Pts. were classified as NHTO or HTO based on race specific cutoff values of serum PTH. NHTO pts. were randomized into treatment (Trx) with teriparatide or standard of care (Ctrl) and HTO pts. into treatment with Alendronate or Ctrl. Demographic and clinical data, lab values, DXA and QCT total hip BMD, and MSQCT measurements of aortic calcium were obtained at baseline and 12 months. Outcomes were changes in BMD and aortic calcification (ΔAC). Declaration of Helsinki was followed.

There were 48 NHTO and 71 HTO pts. The median total PTH was 183 (IQR 138-337) in the NHTO group and 669 (IQR 502-1068) in the HTO group. Treatment groups and turnover arms were well balanced relative to patient race (34% AA), sex (57% m), age (61.0 ±SD 12.5 y), dialysis vintage (4.7 ± 4.0 y) and DXA t-score (-2.9 ± 0.7). Throughout the study, 37 pts. withdrew due to transplantation and personal reasons.

Results

Bone loss was improved in treated NHTO pts. (Trx: +5.7 g/cm3 ±SE 4.7 vs. Ctrl:-10.7 ±SE 4.7, p=.019) but not significantly in HTO pts. (Trx: +0.2 g/cm3 ±SE 5.7 vs. Ctrl: -3.5 ±SE 3.4, p=.577). ΔAC was higher in the HTO arm (NHTO: 4.5 ±SE 1.6 vs. HTO: 8.7 ±SE 1.4, p=.049) and lower in African Americans (AA: 3.6 ±SE 1.7 vs. White: 8.8 ±SE 1.4, p=.017). The multiv. ΔAC regression coefficient for HTO vs. NHTO was 5.0 HU (95% CI 0.9-9.2, p=.019) and for AA vs. Whites was -5.4 (95% CI -9.6—1.1, p=.013). In the NHTO group there were 0 deaths compared to 18% deaths in the HTO group (11 deaths, p = .005).

Conclusion

We demonstrate a benefit to teriparatide for management of osteoporosis in CKD5D pts. with PTH between 138-337 pg/mL. These same pts. had a significant survival benefit relative to the HTO pts. and had less progression of aortic calcification. African American CKD5D pts. experienced less progression of aortic calcification regardless of turnover status or treatment modality.

Funding

  • NIDDK Support