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Safety and Efficacy of PTH 1-34 and 1-84 Therapy in Chronic Hypoparathyroidism: A Meta-Analysis of Prospective Trials |
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| Authors: | Giulia Puliani Valeria Hasenmajer Ilaria Simonelli Valentina Sada Riccardo Pofi Marianna Minnetti Alessia Cozzolino Nicola Napoli Patrizio Pasqualetti Daniele Gianfrilli Andrea M Isidori |
| Institution: | 1. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy
Oncological Endocrinology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Regina Elena National Cancer Institute, Rome, Italy GP and VH contributed equally to this work. Contribution: Data curation, ?Investigation, Resources, Writing - original draft;2. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy GP and VH contributed equally to this work. Contribution: Data curation, ?Investigation, Resources, Writing - original draft;3. Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation of Health Research and Education, Rome, Italy Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy Contribution: Formal analysis, Methodology, Validation, Visualization;4. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy Contribution: Data curation, ?Investigation, Resources;5. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy Contribution: Validation;6. Operative Research Unit of Osteo-metabolic and thyroid diseases, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy;7. Department of Public Health and Infectious Diseases, Section of Medical Statistics, Sapienza University of Rome, Rome, Italy Contribution: Methodology, Supervision;8. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy Contribution: Supervision, Writing - review & editing;9. Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy |
| Abstract: | Hypoparathyroidism is the only endocrine deficiency for which hormone replacement therapy is not the standard of care. Although conventional treatments may control hypocalcaemia, other complications such as hyperphosphatemia, kidney stones, peripheral calcifications, and bone disease remain unmet needs. This meta-analysis (PROSPERO registration number CRD42019126881) aims to evaluate and compare the efficacy and safety of PTH1?34 and PTH1?84 in restoring calcium metabolism in chronic hypoparathyroidism. EMBASE, PubMed, and CENTRAL databases were searched for randomized clinical trials or prospective studies published between January 1996 and March 2021. English-language trials reporting data on replacement with PTH1?34 or PTH1?84 in chronic hypoparathyroidism were selected. Three authors extracted outcomes, one author performed quality control, all assessed the risk of biases. Overall, data from 25 studies on 588 patients were analyzed. PTH therapy had a neutral effect on calcium levels, while lowering serum phosphate (?0.21 mmol/L; 95% confidence interval CI], ?0.31 to ?0.11 mmol/L; p < 0.001) and urinary calcium excretion (?1.21 mmol/24 h; 95% CI, ?2.03 to ?0.41 mmol/24 h; p = 0.003). Calcium phosphate product decreased under PTH1?84 therapy only. Both treatments enabled a significant reduction in calcium and calcitriol supplementation. PTH therapy increased bone turnover markers and lumbar spine mineral density. Quality of life improved and there was no difference in the safety profile between PTH and conventionally treated patients. Results for most outcomes were similar for the two treatments. Limitations of the study included considerable population overlap between the reports, incomplete data, and heterogeneity in the protocol design. In conclusion, the meta-analysis of data from the largest collection to date of hypoparathyroid patients shows that PTH therapy is safe, well-tolerated, and effective in normalizing serum phosphate and urinary calcium excretion, as well as enabling a reduction in calcium and vitamin D use and improving quality of life. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR). |
| Keywords: | HYPOPARATHYROIDISM PTH REPLACEMENT THERAPY TERIPARATIDE PTH1-84 PTH1-34 |