Conte 1994.
Methods | Active vs control Pain measurement tool: 6‐point scale. Patient reported Definition of pain response: a. Some improvement: improvement by 1 point over 2 consecutive reports or by 2 points in 1 report b. Marked improvement: improvement by 2 points over at least 2 consecutive reports |
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Participants | Breast cancer, no previous chemotherapy Bone metastases required Pain not required. Co‐intervention: chemotherapy Performance status criteria: no specifications Other criteria: none | |
Interventions | 1. Active arm:
Pamidronate
Intravenous
45 mg every 3 weeks
Indefinitely until toxicity or progressive bone disease
143 pts 2. Control arm: No additional intervention 152 pts All patients received chemotherapy, standardized for each participating institution |
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Outcomes | 1. Pain:
a. Proportion of patients with reduced pain
No pain: 80/131 pamidronate
70/134 control
Marked improvement:
54/131 pamidronate
38/134 control 2. Analgesic: stated is a secondary endpoint but no data /outcome reported Withdrawals Active arm: 6/143 Control arm: 6/152 Adverse reactions Active arm: Local reaction: 13 Fever: 8 Rigors: 2 Headache: 4 Musculoskeletal pain: 6 Hypocalcemia: 23 Control arm: Local reaction: 7 Fever 4 Rigors 0 Headache: 5 Musculoskeletal pain: 22 Hypocalcemia: 9 |
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Notes | QS = 1 |