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. 2002 Apr 22;2002(2):CD002068. doi: 10.1002/14651858.CD002068

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)
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
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
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
Notes QS = 4