Effects of zoledronic acid on metastatic bone pain in cancer of the prostate: A randomised controlled trial


Background: Advanced cancer of the prostate often causes pain that can be severe requiring palliation with analgesics. Zoledronic acid, a third-generation bisphosphonate, has not been primarily used as an adjunct to treat pain in patients with metastatic bone secondary to advanced prostate cancer in Nigeria. The study investigated the effects of 3 doses of Zoledronic acid, at 4-weekly intervals, in addition to the analgesic regimen of oral morphine, diclofenac, paracetamol and amitriptyline, on bone pain in patients with metastatic prostate cancer .

Methods: A prospective randomized open-labelled trial in which forty patients with moderate to severe bone pain due to metastatic prostate cancer were recruited after institutional ethics approval. Patients were assigned to two groups: The Control (C) group received liquid oral morphine, diclofenac, paracetamol and amitriptyline. Zoledronic acid (ZG) group received 3 doses of Zoledronic acid at 4-weekly intervals in addition to liquid morphine, diclofenac, paracetamol and amitriptyline. Severity of pain and quality of life (QoL) were measured at baseline and weekly for 12 weeks. Data were analysed using means, range, standard deviations and proportions while independent t-test was used to compare the variables between the two groups.

Results: Demographic variables, baseline pain scores and quality of life between the 2 groups were similar. Therewas a statistically significant improvement in pain score in the Zoledronic acid group (1.38±0.53 vs 2.13±0.94) post-intervention, (p = 0.004).

Conclusion: The administration of three doses of Zoledronic acid at 4-weekly intervals significantly improved bone pain score during the 12-weeks follow up in patients with advanced prostate cancer.

Keywords: Zoledronic acid, Bone pain, Prostate cancer.

Contexte: Le cancer avancé de la prostate provoque souvent des douleurs qui peuvent être sévères nécessitant des soins palliatifs avec des analgésiques. L’acide zolédronique, un bisphosphonate de troisième génération, n’a pas été principalement utilisé comme adjuvant pour traiter la douleur chez les patients présentant des métastases osseuses secondaires à un cancer avancé de la prostate au Nigéria. L’étude a examiné les effets de 3 doses d’acide zolédronique, à des intervalles de 4 semaines, en plus du régime analgésique de morphine orale, de diclofénac, de paracétamol et d’amitriptyline, sur la douleur osseuse chez les patients atteints d’un cancer métastatique de la prostate.

Méthodes: Un essai prospectif randomisé ouvert dans lequel quarante patients souffrant de douleurs osseuses modérées à sévères dues à un cancer métastatique de la prostate ont été recrutés après approbation éthique de l’établissement. Les patients ont été répartis en deux groupes: Le groupe témoin (C) a reçu de la morphine orale liquide, du diclofénac, du paracétamol et de l’amitriptyline. Le groupe acide zolédronique (ZG) a reçu 3 doses d’acide zolédronique à intervalles de 4 semaines en plus de la morphine liquide, du diclofénac, du paracétamol et de l’amitriptyline. La sévérité de la douleur et la qualité de vie (QdV) ont été mesurées au départ et chaque semaine pendant 12 semaines. Les données ont été analysées à l’aide des moyennes, de la plage, des écarts-types et des proportions, tandis qu’un test t indépendant a été utilisé pour comparer les variables entre les deux groupes.

Résultats: Les variables démographiques, les scores de douleur de base et la qualité de vie entre les 2 groupes étaient similaires. Il y avait une amélioration statistiquement significative du score de douleur dans le groupe acide zolédronique (1,38 ± 0,53 vs 2,13 ± 0,94) après l’intervention, (p = 0,004).

Conclusion: L’administration de trois doses d’acide zolédronique à des intervalles de 4 semaines a significativement amélioré le score de douleur osseuse au cours des 12 semaines de suivi chez les patients atteints d’un cancer de la prostate avancé.

Mots clés: Acide zolédronique, douleur osseuse, cancer de la prostate.

Correspondence: Dr. M.O . Akinwale, Department of Anaesthesia, College of Medicine, University of Ibadan, Ibadan. Nigeria E-mail: akinsmko@yahoo.com, moakinwale@com.ui.edu.ng



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