Elomaa 1992.
Methods | Active vs placebo control Definition of pain response: proportion with no pain Analgesic response definition: proportion with no analgesic |
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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 |
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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 |
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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. |
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Notes | QS = 2 |