Abstract: TH-PO1249
Extended-Release Calcifediol Improves Skeletal Remodeling Balance as Assessed by a CKD-Adapted Bone Balance Index
Session Information
- Late-Breaking Research Posters
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 502 Bone and Mineral Metabolism: Clinical
Authors
- Ashfaq, Akhtar, OPKO Health Inc, Miami, Florida, United States
- Choe, John, OPKO Health Inc, Miami, Florida, United States
- Bhatt, Kinal, OPKO Health Inc, Miami, Florida, United States
- Bishop, Charles W., OPKO Health Inc, Miami, Florida, United States
Group or Team Name
- OPKO Renal Division
Background
Normal bone remodeling requires coordinated coupling of resorption and formation. Serum bone turnover markers assess bone resorption and formation individually but do not directly quantify skeletal remodeling balance. A chronic kidney disease (CKD)-adapted bone balance index (BBI) was used to monitor remodeling balance during treatment with extended-release calcifediol (ERC).
Methods
BBI was calculated using a reference equation derived from paired baseline measurements of C-terminal telopeptide of type 1 collagen (CTX) and intact procollagen type 1 N-terminal propeptide (P1NP) from 351 adults with secondary hyperparathyroidism (SHPT), CKD stage 3 or 4, and vitamin D insufficiency (VDI) who participated in two identical randomized controlled trials. Changes in BBI over 26 weeks of treatment with either ERC (30 or 60 mcg/day) or placebo were assessed post-hoc using a linear mixed-effects model and confirmed at end of study (EOS) by analysis of covariance (ANCOVA).
Results
Adjusted mean BBI progressively increased with ERC but remained unchanged with placebo yielding an overall treatment difference of 0.285 (95% CI, 0.093–0.477; P = 0.0036) in the longitudinal analysis. ANCOVA at EOS confirmed an adjusted mean BBI difference of 0.275 (95% CI, 0.072–0.478; P = 0.0080) corresponding to observed CTX averaging 79.3 pg/mL (11.1%) lower than expected for the concurrent P1NP level. Directional improvement in BBI occurred more frequently during treatment with ERC (62.4%) than placebo (45.7%; P = 0.003) with no effect of CKD stage.
Conclusion
A significant, sustained improvement in BBI was observed after 26 weeks of treatment with ERC versus placebo in adults with SHPT, CKD stage 3 or 4, and VDI, indicating a shift toward improved skeletal remodeling.
Funding
- Commercial Support – OPKO Health, Inc.