Kylmala 1997.
Methods | Active vs placebo Pain measurement tool: 10 cm VAS, 0‐4 ordinal scale Pain scores expressed by: patient (VAS) physician (ordinal scale) Definition of pain response: not applicable Analgesic scale: 3 point scale (0: none, 1: non narcotics <x3/d, 2: non narcotic >x3/d, 3: narcotics) |
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Participants | Prostate cancer (hormonal therapy) Bone metastases required No pain required Co‐intervention: hormonal/chemotherapy Performance status criteria: none Other exclusion radiotherapy within 2 weeks |
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Interventions | 1. Active arm:
Clodronate
300 mg/day IV x5 days, then 1.6 g/day oral x12 months
28 pts 2. Control arm: Placebo 29 pts All patients receive Estramustine |
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Outcomes | 1. Pain:
No significant difference in any pain score 2. Analgesic: a. Proportion of patients with reduced analgesic Others: a. Performance status change b. Clinical response i.e. better, same, or worse as scored by doctor c. Radiological response d. Biochemical markers of bone resorption, serum calcium, alkaline phosphatase. e. PSA levels Withdrawals: Active arm: 0/28 Control arm: 2/29 Adverse effects: Active arm: Nausea: 9 Control arm: Nausea: 11 |
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Notes | QS = 4 |