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. 2020 Dec 3;2020(12):CD013020. doi: 10.1002/14651858.CD013020.pub2

Kylmala 1997.

Study characteristics
Methods Recruitment period:

  • not reported


Outcomes:

  • bone pain, analgesic consumption, performance status, clinical response


Pain assessment tool:

  • visual analouge scale (VAS) for pain assessment

  • verbal ordinal scale for pain assessment, 0 = no pain to 4 = intolerable pain


Randomization:

  • intervention vs control
Participants Eligibility criteria:

  • prostate cancer metastatic to bone

  • estimated life expectancy ≥ 6 months

  • oral consent

  • no radiation therapy within 2 weeks before study enrollment

  • no peptic ulcer treated with antacids

  • no clinically relevant renal or hepatic insufficiency


Exclusion criteria:

  • not reported


Participants randomized:

  • 57 randomized, 28 intervention, 29 control


Mean age:

  • intervention: 72 years

  • control: 76 years


Country of participants:

  • not reported
Interventions Previous interventions:

  • 42 participants underwent orchiectomy, 20 in intervention group, 22 in control group

  • 12 participants received estrogens, 5 in intervention group, 7 in control group

  • 6 participants received LHRH agonists, 1 in intervention group, 5 in control group

  • 4 participants received antiandrogens, 3 in intervention group, 1 in control group

  • 2 participants underwent radiation of prostate, 2 in intervention group, 0 in control group


Interventions during study period:

  • intervention: clodronate 300 mg IV daily and estramustine 280 mg orally twice daily for 5 days, clodronate 1600 mg orally daily and estramustine 280 mg orally twice daily for 5 months

  • control: placebo IV daily and estramustine 280 mg orally twice daily for 5 days, placebo orally daily and estramustine 280 mg orally twice daily for 5 months
Outcomes Reported and analyzed in this review:

  • pain response

  • adverse events
Funding sources Funding sources:

  • Finnish Cancer Foundation

  • Leiras, Clinical Research

  • Finnish Academy of Sciences

  • Finnish Medical Society Duodecim

  • Reino Lathikari Foundation
Declarations of interest Conflicts of interest:

  • not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information on sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient information on allocation concealment
Blinding of participants and personnel (performance bias)
Blinding of participants Unclear risk Placebo‐controlled trial, no further information on blinding
Blinding of participants and personnel (performance bias)
Blinding of personnel Unclear risk No information on blinding of personnel
Blinding of outcome assessment (detection bias)
Outcomes subjective to participants Unclear risk Placebo‐controlled trial, no further information on blinding
Incomplete outcome data (attrition bias)
Patient‐reported outcomes (other than safety data) Unclear risk No information regarding discontinuations and ITT
Incomplete outcome data (attrition bias)
Safety data Unclear risk No information regarding discontinuations and ITT
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk None identified