Randomised study to access the efficacy of calcitonin in controlling pain in patients of metastatic bone lesions poorly responding to opioids
Authors: T. Durga, P. K. Julka
Journal: Journal of Clinical Oncology (2005)

8002 Background: Pain control in bony metastasis in malignancies is an important aspect of cancer care. More than 60% of patients with advanced malignancies have significant pain, associated severe limitation of activities and thus decreased quality of life. Methods: Between July 2001 and July 2002, 58 cancer patients with painful bony metastasis not responding to opioids and bisphosphonates were enrolled in this study. After Baseline assessment patients were randomized to two arms. 1. Arm1 (Calcitonin arm): Patients received injection Calcitonin 200 IU sc daily X 6 weeks. 2. Arm-2 (Placebo arm):Patients received physiological fluid 5 cc sc daily X 6 weeks Both the arms were well balanced. The following were essential criterion for inclusion of patients in the study. I) Patients with radiologically confirmed bone metastasis. II) KPS>40 III) Age>15 yrs IV) No bisphosphonates for last 2 months. V) Normal/raised serum calcium. VI) Informed consent VII) Pain not responding/ poorly controlled by opioids. Patients were assessed for pain control using VAS scores along with other characteristics at weekly intervals for a minimum period of 3 months. 40 patients were evaluable and were included for final analysis.18 patients, 9 from each arm were lost to follow up,withdrew or didn’t complete the study. Results: 15 patients in calcitonin arm had >75% pain relief compared to only 1 patient in the control group. (p<0.001). 6 patients in the calcitonin arm had more than 50% reduction in analgesics compared to nil in the control group. (p< 0.05). Effect of Calcitonin versus placebo on pain and associated parameters. Conclusion: Calcitonin is an effective drug in the management of pain due to bony metastasis and merits larger trials to define the dose and the schedule of administration. S no Parameters Arm 1 Arm 2 p value 1 Pain relief -NO RELIEF 1 14 p <0.001 Mild relief <50% 1 4 Moderate relief 50–75% 3 1 Marked relief >75% 11 1 No Pain 100%,opiates could be withdrawn 4 0 2 Reduction in analgesics-No reduction 12 18 p< 0.05 Reduction <25% - 1 Reduction 26–50% 2 1 Reduction > 50% 6 - 3 Pain free interval - 1 12 p< 0.001 6–8hr 2 7 8–10hrs 7 1 10hrs 10 - 4 Sleep Disturbance -No disturbance 18 2 p< 0.001 Breakthrough pain leading to waking up once in night 1 2 Breakthrough pain leading to waking up 3–4 times in night - 6 Cannot sleep due to pain 1 10 6 Appetite Deteriorated 1 14 p<0.001 No change 3 4 Improved 16 2 7 Weight in Last 2 m -Deteriorated 1 14 p< 0.001 No weight gain 4 4 Weight gain 15 2 8 Patient general well being- Feels well and desires to continue Rx 18 3 p<0.001 No change & doesn’t desire to continue Rx 2 17 9 Improvement in Psychological status 3m after Rx- Depression prior to treatment Starting Rx 14 14 p=1 Pts. With Depression after treatment 4 3 Pts. With Desire to die prior to treatment 1 1 Pts. With Desire to die after Rx 1 2 10 Radiological changes over 3 m period- No change 19 18 p=1 Increase in bone lesions size 1 2 Change in Serum Calcium Value during Rx 5 4 p=1 No significant financial relationships to disclose.