A double-blind, crossover trial of intravenous clodronate in metastatic bone pain
Female; Humans; Male; Pain Measurement; Adult; Aged; Middle Aged; Double-Blind Method; 80 and over; Infusions; Intravenous; Clodronate; Clodronic Acid/administration & dosage/therapeutic use; Bone Neoplasms/physiopathology/secondary; Pain/diagnosis/drug therapy/etiology
After a baseline symptom and laboratory assessment, 24 patients with metastatic bone disease and pain were randomized to receive either a 4-hr intravenous infusion of 2-dichloromethylene bisphosphonate (Cl2MDP), 600 mg in 500 mL of normal saline, or a 4-hr placebo infusion, 500 mL of normal saline. The administration was double blind. After 1 wk, the assessment was repeated and the patients were crossed over to the alternate treatment. After 1 more wk, a final assessment and blinded choice by the patient and investigator took place. Of the 21 evaluable patients, 12 (57%) chose the Cl2MDP and 4 (19%) chose the placebo; 5 (24%) patients did not have a specific preference (p = NS). The investigator chose the Cl2MDP in 14 (67%) cases, placebo in 6 (29%) cases and was unable to discern a difference in 1 (5%) case (p less than 0.05). The patients and investigator made similar selections in 16 (76%) instances. On the visual analogue scale assessments, a significant decrease in pain scores was observed following the Cl2MDP infusion (p less than 0.01) and an increase in activity scores was also demonstrated (p less than 0.01). No significant difference in the daily oral morphine equivalent analgesic requirement was demonstrated for either arm. No difference in clinical and laboratory parameters of toxicity was evident between the placebo and Cl2MDP arms of the trial. Our preliminary findings suggest that Cl2MDP is safe, and has analgesic properties that may prove to be useful in the management of metastatic bone pain.
1992
Ernst DS; MacDonald RN; Paterson AH; Jensen J; Brasher P; Bruera E
Journal Of Pain And Symptom Management
1992
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/0885-3924(92)90101-m" target="_blank" rel="noreferrer">10.1016/0885-3924(92)90101-m</a>
A randomized, controlled trial of intravenous clodronate in patients with metastatic bone disease and pain
Female; Humans; Male; Pain; Adult; Analgesics; Aged; Middle Aged; Treatment Outcome; Analysis of Variance; Chi-Square Distribution; Cross-Over Studies; 80 and over; Comparative Study; Injections; Intravenous; Dose-Response Relationship; Drug; Clodronate; Pain Measurement/drug effects; Clodronic Acid/administration & dosage; Non-Narcotic/administration & dosage; Intractable/drug therapy/etiology; Bone Neoplasms/complications/secondary
To evaluate the effectiveness of intravenous clodronate in ameliorating refractory bone pain in patients with metastatic bone disease, 60 patients with established osseous metastases and persistent bone pain were randomized to receive either clodronate (600 mg or 1500 mg in 500 mL of normal saline) or 500 mL of saline as placebo. After 2 weeks, the patients were crossed over to receive the alternate treatment. After another 2 weeks, each patient and investigator made a blinded choice. Daily visual analogue scales (VAS) and analgesic diaries were recorded throughout the study period. Forty-six patients were evaluable (77%). A treatment x period interaction was identified in the VAS and daily morphine equivalent dose (DMED) scores. First period analysis of the VAS scores for general pain, pain at rest, and pain upon movement demonstrated an average reduction of 13, 14, and 24 mm, respectively, from baseline, but were not significantly different from changes following placebo. The average change in DMED was -6.4 (SE = 2.9) following clodronate and was +24.6 (SE = 14.9) following placebo (p = 0.03). In the blinded choice of which agent resulted in improvement in pain, 26 (57%) patients chose clodronate, 12 (26%) chose placebo, and eight (17%) had no preference (p = 0.0021). For the investigators who also made a blinded selection, clodronate was chosen in 30 (65%) patients, placebo in ten (22%) patients, and no difference was apparent in six (13%) (p < 0.0001). Intravenous clodronate appeared to have analgesic effect in patients with refractory bone pain due to metastatic bone disease. The optimal dose and duration of effect require further evaluation, particularly in patients with stable disease and persistent bone pain.
1997
Ernst DS; Brasher P; Hagen N; Paterson AH; MacDonald RN; Bruera E
Journal Of Pain And Symptom Management
1997
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/s0885-3924(97)00075-4" target="_blank" rel="noreferrer">10.1016/s0885-3924(97)00075-4</a>