Abstract: PO0549
Etelcalcetide Improves Central Skeleton Bone Quality and Density in Patients on Hemodialysis
Session Information
- Bone and Mineral Metabolism: Clinical
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Khairallah, Pascale, Baylor College of Medicine, Houston, Texas, United States
- Sung, Joshua C., Columbia University Irving Medical Center, New York, New York, United States
- Aponte Farias, Maria A., Columbia University Irving Medical Center, New York, New York, United States
- Agarwal, Sanchita, Columbia University Irving Medical Center, New York, New York, United States
- Frumkin, Gail Nurit, Rogosin Institute, New York, New York, United States
- Bohmart, Andrew, Rogosin Institute, New York, New York, United States
- El Hachem, Karim, Icahn School of Medicine at Mount Sinai Department of Medicine, New York, New York, United States
- Silberzweig, Jeffrey I., Rogosin Institute, New York, New York, United States
- Mcmahon, Donald J., Columbia University Irving Medical Center, New York, New York, United States
- Allen, Matthew R., Indiana University School of Medicine, Indianapolis, Indiana, United States
- Nickolas, Thomas, Columbia University Irving Medical Center, New York, New York, United States
Background
Secondary hyperparathyroidism (SHPT) is an important complication of dialysis. It is associated with osteoporosis and fractures. Etelcalcetide is an intravenous calcimimetic superior to cinacalcet in control of parathyroid hormone (PTH) in hemodialysis (HD) patients. The effects of etelcalcetide on bone quality and density are unknown. We hypothesized that etelcalcetide improves spine trabecular bone score (TBS), a marker of central skeletal trabecular bone quality, and bone mineral density (BMD) by dual energy X-ray absorptiometry (DXA) in HD patients.
Methods
Eligible subjects were ≥18 yo, on HD ≥1 year, normocalcemic, without calcimimetic exposure within 3 months of enrollment. Treatment included a 3-month dose titration phase to target a PTH level 2-5 times the upper limit of normal, followed by a 6-month maintenance phase. TBS and DXA were obtained at both baseline (pre-treatment) and at 9-months (end of study). Intact PTH was obtained at pre-treatment, 3- and 9-months post-treatment. Mixed models assessed change in TBS and age, sex, race Z-Scores adjusted for change in PTH.
Results
22 subjects were enrolled;13 completed follow-up. Among the 13 subjects: mean±SD age was 51±14 yrs; 53% male; 15% white. Median(min-max) PTH (pg/mL) levels at baseline, 3- and 9-months were 692(456-959), 266(18-1256) and 156(40-885) respectively. From baseline to 9-months of treatment, TBS improved by 7.4±2.6% (p=0.008). Z-Scores at the spine, femoral neck and total hip increased by 0.5, 0.4 and 0.3 SDs respectively (Table). There were no changes at the forearm.
Conclusion
Treatment of SHPT with etelcalcetide for 9 months was associated with improvements in trabecular quality and central skeleton BMD. Further studies are needed to determine the effects of etelcalcetide on tissue-level bone quality, bone strength and fracture resistance.
Baseline DXA parameters and Change in DXA parameters following treatment with etelcalcetide
| Parameter | Baseline (Mean±SD) | Change (Mean±SE) | p-value |
| Z-Score Lumbar Spine | 0.2±1.7 | 0.5±0.1 | 0.001 |
| Z-Score Femoral Neck | -0.1±1.0 | 0.4±0.2 | 0.03 |
| Z-Score Total Hip | -0.5±1.1 | 0.3±0.1 | 0.006 |
| Z-Score 1/3 Radius | -1.1 ±1.8 | -0.2±0.1 | 0.07 |
| Z-Score Ultradistal Radius | -1.2±1.2 | -0.07±0.1 | 0.6 |
Funding
- Commercial Support –