Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial
Purpose: Literature on the treatment of pre-transplant hepatic osteodystrophy (HOD) is limited. The general treatment measures and their timing are currently adopted from the literature on postmenopausal osteoporosis. Therefore, we conducted this randomized study to investigate the effect of zoledro...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2023-01-01
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| Series: | Indian Journal of Endocrinology and Metabolism |
| Subjects: | |
| Online Access: | http://www.ijem.in/article.asp?issn=2230-8210;year=2023;volume=27;issue=6;spage=552;epage=558;aulast=Raj |
| _version_ | 1797300000659603456 |
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| author | Henith Raj Sadishkumar Kamalanathan Jayaprakash Sahoo Pazhanivel Mohan Krishnan Nagarajan Sagili V B. Reddy Harsh Durgia Rajan Palui |
| author_facet | Henith Raj Sadishkumar Kamalanathan Jayaprakash Sahoo Pazhanivel Mohan Krishnan Nagarajan Sagili V B. Reddy Harsh Durgia Rajan Palui |
| author_sort | Henith Raj |
| collection | DOAJ |
| description | Purpose: Literature on the treatment of pre-transplant hepatic osteodystrophy (HOD) is limited. The general treatment measures and their timing are currently adopted from the literature on postmenopausal osteoporosis. Therefore, we conducted this randomized study to investigate the effect of zoledronic acid (ZA) on HOD. Methods: We randomized 36 male patients with cirrhosis (Child–Pugh class A and B) into 19 to the ZA arm and 17 to the placebo arm, respectively. Patients in the ZA arm received a single infusion of 4 mg ZA dissolved in 100 mL of normal saline at baseline, while patients in the placebo arm received a similar infusion of normal saline at baseline. The primary outcome of the study was the change in lumbar spine bone mineral density (LS-BMD) at 12 months. Results: Of 36 patients, 28 completed the study (15 in the ZA arm and 13 in the placebo arm). The mean increase in LS-BMD (g/cm2) in the ZA and placebo arms was 5.11% (3.50) and 0.72% (4.63) [P = 0.008], respectively. The trabecular bone score (TBS) did not improve significantly in either arm. The incidence of vertebral fractures (VFs) was similar in both arms. There was a significant decrease in plasma beta-C-terminal telopeptide (β-CTX) levels in the ZA arm compared to the placebo arm, while the change in plasma levels of procollagen 1 intact N-terminal propeptide (P1NP) was similar in both arms. Six patients (31.6%) in the ZA arm experienced adverse reactions such as fever and myalgia. Conclusion: ZA improved LS-BMD in male patients with HOD by decreasing bone resorption. However, it may not improve trabecular microarchitecture or prevent morphometric VFs in this population. |
| first_indexed | 2024-03-07T22:59:52Z |
| format | Article |
| id | doaj.art-1ad3282836654bb39f893e2a94bec12b |
| institution | Directory Open Access Journal |
| issn | 2230-8210 |
| language | English |
| last_indexed | 2024-03-07T22:59:52Z |
| publishDate | 2023-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Indian Journal of Endocrinology and Metabolism |
| spelling | doaj.art-1ad3282836654bb39f893e2a94bec12b2024-02-22T14:51:33ZengWolters Kluwer Medknow PublicationsIndian Journal of Endocrinology and Metabolism2230-82102023-01-0127655255810.4103/ijem.ijem_233_23Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trialHenith RajSadishkumar KamalanathanJayaprakash SahooPazhanivel MohanKrishnan NagarajanSagili V B. ReddyHarsh DurgiaRajan PaluiPurpose: Literature on the treatment of pre-transplant hepatic osteodystrophy (HOD) is limited. The general treatment measures and their timing are currently adopted from the literature on postmenopausal osteoporosis. Therefore, we conducted this randomized study to investigate the effect of zoledronic acid (ZA) on HOD. Methods: We randomized 36 male patients with cirrhosis (Child–Pugh class A and B) into 19 to the ZA arm and 17 to the placebo arm, respectively. Patients in the ZA arm received a single infusion of 4 mg ZA dissolved in 100 mL of normal saline at baseline, while patients in the placebo arm received a similar infusion of normal saline at baseline. The primary outcome of the study was the change in lumbar spine bone mineral density (LS-BMD) at 12 months. Results: Of 36 patients, 28 completed the study (15 in the ZA arm and 13 in the placebo arm). The mean increase in LS-BMD (g/cm2) in the ZA and placebo arms was 5.11% (3.50) and 0.72% (4.63) [P = 0.008], respectively. The trabecular bone score (TBS) did not improve significantly in either arm. The incidence of vertebral fractures (VFs) was similar in both arms. There was a significant decrease in plasma beta-C-terminal telopeptide (β-CTX) levels in the ZA arm compared to the placebo arm, while the change in plasma levels of procollagen 1 intact N-terminal propeptide (P1NP) was similar in both arms. Six patients (31.6%) in the ZA arm experienced adverse reactions such as fever and myalgia. Conclusion: ZA improved LS-BMD in male patients with HOD by decreasing bone resorption. However, it may not improve trabecular microarchitecture or prevent morphometric VFs in this population.http://www.ijem.in/article.asp?issn=2230-8210;year=2023;volume=27;issue=6;spage=552;epage=558;aulast=Rajbone mineral densitybone turnover markershepatic osteodystrophytrabecular bone scorezoledronic acid |
| spellingShingle | Henith Raj Sadishkumar Kamalanathan Jayaprakash Sahoo Pazhanivel Mohan Krishnan Nagarajan Sagili V B. Reddy Harsh Durgia Rajan Palui Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial Indian Journal of Endocrinology and Metabolism bone mineral density bone turnover markers hepatic osteodystrophy trabecular bone score zoledronic acid |
| title | Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial |
| title_full | Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial |
| title_fullStr | Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial |
| title_full_unstemmed | Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial |
| title_short | Effect of zoledronic acid in hepatic osteodystrophy: A double-blinded placebo-controlled trial |
| title_sort | effect of zoledronic acid in hepatic osteodystrophy a double blinded placebo controlled trial |
| topic | bone mineral density bone turnover markers hepatic osteodystrophy trabecular bone score zoledronic acid |
| url | http://www.ijem.in/article.asp?issn=2230-8210;year=2023;volume=27;issue=6;spage=552;epage=558;aulast=Raj |
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