Early Therapeutic Response of Bone Turnover Markers to Alendronate and Vitamin D3 in Older Women with High Fracture Risk: A Clinical Trial
Abstract
Background: Bone turnover markers are expected to decrease significantly after receiving anti-resorptive treatment in osteoporosis and they can be used to monitor the efficacy of the treatment.
Objectives: This study evaluated changes in serum procollagen type I N-propeptide (P1NP), a marker of bone formation, and serum cross-linked C-telopeptide of type I collagen (CTX), a marker of bone resorption, following treatment with alendronate (ALN) and vitamin D3 (VitD3) in postmenopausal women with high fracture risk.
Materials & Methods: Postmenopausal women with high fracture risk were recruited from the Galle area of Southern, Sri Lanka and randomly assigned into the treatment (n=30) and control (n=30) groups. Treatment group received oral ALN (70 mg/week) with oral VitD3 (1000 IU/day). Control group received VitD3 (1000 IU/day) along with a matching placebo (PLB). CTX and PINP were measured at baseline and after six months, and means were compared by paired t-test. CTX and PINP were measured by ELISA and body composition was measured by DXA.
Results: In the treatment group, mean CTX and PINP levels at baseline were 3.12 ng/mL and 262 pg/mL, respectively, while respective mean values for the control group were 2.66 ng/mL and 409 pg/mL. After six months, mean CTX and PINP levels in the treatment group were 1.24 ng/mL and 159 pg/mL, respectively, while in the control group, the respective mean values were 3.01 ng/mL and 412 pg/mL. In the treatment group, CTX and PINP levels were significantly decreased by 60% (p=0.001) and 39% (p=0.005), respectively, after six months compared to the baseline levels. Significant differences were not observed in the control group for mean CTX (p=0.43) and PINP (p=0.97) after six months compared to baseline.
Conclusion: A combination of alendronate and VitD3 treatment significantly reduces the bone turnover markers compared to VitD3 and placebo treatment.
Objectives: This study evaluated changes in serum procollagen type I N-propeptide (P1NP), a marker of bone formation, and serum cross-linked C-telopeptide of type I collagen (CTX), a marker of bone resorption, following treatment with alendronate (ALN) and vitamin D3 (VitD3) in postmenopausal women with high fracture risk.
Materials & Methods: Postmenopausal women with high fracture risk were recruited from the Galle area of Southern, Sri Lanka and randomly assigned into the treatment (n=30) and control (n=30) groups. Treatment group received oral ALN (70 mg/week) with oral VitD3 (1000 IU/day). Control group received VitD3 (1000 IU/day) along with a matching placebo (PLB). CTX and PINP were measured at baseline and after six months, and means were compared by paired t-test. CTX and PINP were measured by ELISA and body composition was measured by DXA.
Results: In the treatment group, mean CTX and PINP levels at baseline were 3.12 ng/mL and 262 pg/mL, respectively, while respective mean values for the control group were 2.66 ng/mL and 409 pg/mL. After six months, mean CTX and PINP levels in the treatment group were 1.24 ng/mL and 159 pg/mL, respectively, while in the control group, the respective mean values were 3.01 ng/mL and 412 pg/mL. In the treatment group, CTX and PINP levels were significantly decreased by 60% (p=0.001) and 39% (p=0.005), respectively, after six months compared to the baseline levels. Significant differences were not observed in the control group for mean CTX (p=0.43) and PINP (p=0.97) after six months compared to baseline.
Conclusion: A combination of alendronate and VitD3 treatment significantly reduces the bone turnover markers compared to VitD3 and placebo treatment.
DOI: https://doi.org/10.4038/jnfs.v4i2.28 | Journal eISSN: 2815-0155
Language: English
Page range: 37 - 47
Published on: Dec 30, 2025
Published by: The Nutrition Society of Sri Lanka
In partnership with: Paradigm Publishing Services
Keywords:
© 2025 P. H. Rathnayake, S. Lekamwasam, C. M. Wickramatilake, J. Lenora, published by The Nutrition Society of Sri Lanka
This work is licensed under the Creative Commons Attribution 4.0 License.