Strang 1997.

Study characteristics
Methods	Recruitment period: June 1993 to May 1995 Outcomes: bone pain Pain assessment tool: 10‐centimeter VAS Randomization: intervention vs control
Participants	Eligibility criteria: primary or secondary hormone‐refractory prostate cancer with persisting pain > 2 cm on VAS caused by bone metastasis life expectancy > 3 months Exclusion criteria: impaired renal function use of bisphosphonates or other drugs affecting calcium metabolism within 3 weeks before study enrollment palliative radiation therapy within 3 weeks before study enrollment Participants randomized: 55 randomized, but only 52 participants evaluable for efficacy analysis, 25 intervention (clodronate IV and clodronate orally), 27 control (placebo IV and placebo orally) Mean age: intervention: 71 years control: 74 years Country of participants: not reported
Interventions	Previous interventions: not reported Interventions during study period: intervention: clodronate 300 mg IV daily for 3 days following clodronate 3200 mg orally daily for 4 weeks control: isotonic saline IV daily for 3 days following placebo tablets orally daily for 4 weeks
Outcomes	Reported and analyzed in this review: pain response
Funding sources	Funding sources: Leiras OY Finland ASTRA Lakemedel Sweden
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 reporting on sequence generation
Allocation concealment (selection bias)	Unclear risk	Insufficient information on allocation concealment
Blinding of participants and personnel (performance bias) Blinding of participants	Low risk	"randomized double‐blind multicenter study"
Blinding of participants and personnel (performance bias) Blinding of personnel	Low risk	"randomized double‐blind multicenter study"
Blinding of outcome assessment (detection bias) Outcomes subjective to participants	Low risk	"randomized double‐blind multicenter study"
Blinding of outcome assessment (detection bias) Outcomes subjective to outcome assessors	Unclear risk	Insufficient reporting on blinding of outcome assessors
Incomplete outcome data (attrition bias) Patient‐reported outcomes (other than safety data)	High risk	Number of randomized participants is more than the number of participants that underwent efficacy analyses.
Selective reporting (reporting bias)	Unclear risk	No study protocol available.
Other bias	High risk	Terminated prematurely due to low recruiting.