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

Elomaa 1992.

Methods Active vs placebo control
Definition of pain response: proportion with no pain
Analgesic response definition: proportion with no analgesic
Participants Prostate cancer (failed 1 hormone)
Bone metastases required
Pain required
Co‐intervention: chemotherapy/hormonal therapy
Performance status criteria: life expectancy >/=3 months
Other criteria: exclude radiotherapy within 2 weeks
Interventions 1. Active arm:
 Clodronate Oral
 3.2 g per day for one month, then 1.6 g per day for 5 months
 For 6 months
 36 pts
2. Control arm:
 Placebo 39 pts
All patients received Estramustine
Outcomes 1. Pain:
 a. Proportion of patients with no pain
2. Analgesic:
 Analgesic consumption reduced in 15/17 Clodronate
 3/17 placebo
Others:
 a. Serum calcium
 b. Survival
Evaluable data: 12 pts receiving Clodronate and 10 pts from the placebo group died within the first year of the study
No adverse effects reported.
Notes QS = 2