Abstract: PO2382
Effect of Oral Sodium Bicarbonate on Biomarkers of Bone Turnover in CKD: A Secondary Analysis of the BASE Pilot Trial
Session Information
- CKD: Insights from Recent Clinical Trials and Large Real-World Effectiveness Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Raphael, Kalani L., Oregon Health & Science University School of Medicine, Portland, Oregon, United States
- Katz, Ronit, University of Washington, Seattle, Washington, United States
- Isakova, Tamara, Northwestern University, Evanston, Illinois, United States
- Sprague, Stuart M., NorthShore University HealthSystem, Evanston, Illinois, United States
- Wolf, Myles, Duke University, Durham, North Carolina, United States
- Raj, Dominic S., George Washington University Medical Faculty Associates, Washington, District of Columbia, United States
- Hoofnagle, Andrew N., University of Washington, Seattle, Washington, United States
- Larive, Brett, Cleveland Clinic, Cleveland, Ohio, United States
- Kendrick, Cynthia A., Cleveland Clinic, Cleveland, Ohio, United States
- Gassman, Jennifer J., Cleveland Clinic, Cleveland, Ohio, United States
- Fried, Linda F., VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States
- Cheung, Alfred K., University of Utah Health, Salt Lake City, Utah, United States
- Ix, Joachim H., University of California San Diego, La Jolla, California, United States
Background
CKD clinical practice guidelines recommend treatment with alkali to mitigate adverse effects of metabolic acidosis on several organ systems, including bone. The effect of alkali supplementation on bone turnover in CKD is unclear. We performed a secondary analysis of the Bicarbonate Administration to Stabilize eGFR (BASE) Pilot Trial to investigate the effect of NaHCO3 on biomarkers of bone turnover.
Methods
BASE randomized 194 individuals with eGFR 20-59 ml/min/1.73m2 to receive placebo (n=52) or one of two doses of NaHCO3 (0.5 mEq/kg/d, n=52; 0.8 mEq/kg/d, n=90) for 28 weeks. We measured serum parathyroid hormone (PTH), bone-specific alkaline phosphatase (B-SAP), c-telopeptide (CTX, marker of bone resorption), and procollagen type I intact N-terminal propeptide (PINP, marker of bone formation) levels from stored samples collected at baseline, week 12, and week 28, and compared the mean change from baseline between placebo and those treated with NaHCO3 using linear mixed models.
Results
168 of 194 participants (86%) submitted samples for post-hoc measurements (placebo, n=46; lower-dose, n=47; higher-dose, n=75). Baseline characteristics were age 67±12 years, female 28%, Black, 32%, Hispanic 15%, eGFR 37±10 ml/min/1.73m2, serum total CO2 24±3 mEq/L, B-SAP 12.8±5.6 μg/L , CTX 0.36±0.38 ng/mL, PINP 57±31 ng/mL. NaHCO3 treatment raised PTH and lowered B-SAP, however there was no significant difference when compared to placebo. NaHCO3 treatment had no effect on CTX or PINP (Table).
Conclusion
NaHCO3 treatment did not have consistent effects on biomarkers of bone turnover as assessed by PTH, B-SAP, CTX, or PINP, and no significant effects relative to placebo in patients with CKD.
| Variable | Treatment | Baseline | Week 12 | Week 28 | Mean Δ (95% CI) | Within group p-value | Between group p-value |
| Intact PTH (pg/mL) | Placebo | 70 (66) | 84 (86) | 69 (65) | 0.41 (-0.51, 5.88) | 0.883 | 0.140 |
| NaHCO3 | 64 (55) | 71 (72) | 71 (59) | 5.25 (1.88, 8.61) | 0.002 | ||
| B-SAP (μg/L) | Placebo | 13.2 (6.4) | 12.4 (5.5) | 12.9 (5.1) | -0.16 (-0.51, 0.19) | 0.366 | 0.621 |
| NaHCO3 | 12.7 (5.3) | 12.6 (5.0) | 12.3 (4.9) | -0.26 (-0.47, -0.05) | 0.014 | ||
| CTX (ng/mL) | Placebo | 0.35 (0.39) | 0.36 (0.40) | 0.34 (0.31) | -0.001 (-0.03, 0.03) | 0.932 | 0.920 |
| NaHCO3 | 0.36 (0.37) | 0.34 (0.38) | 0.35 (0.33) | 0 (-0.02, 0.02) | 0.747 | ||
| PINP (ng/mL) | Placebo | 55 (31) | 58 (37) | 53 (25) | -1.05 (-3.67, 1.56) | 0.430 | 0.676 |
| NaHCO3 | 58 (31) | 58 (31) | 58 (31) | -0.39 (-2.03, 1.25) | 0.640 |
Funding
- NIDDK Support