GU02‐4.

Study characteristics
Methods	Recruitment period: December 2003 to August 2005 Outcomes: overall survival, disease progression, adverse events Pain assessment tool: not reported Randomization: intervention vs control
Participants	Eligibility criteria: performance status: ECOG 0 to 2 life expectancy: ≥ 12 weeks histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, Magnetic resonance imaging (MRI) or bone scan) with plans to start or be < 30 days from beginning androgen deprivation therapy patients may have received palliative radiation therapy at the investigator's discretion during the first 4 weeks of beginning protocol therapy Exclusion criteria: no neuroendocrine, small cell, or transitional cell cancer of prostate no abnormal bone metabolism (i.e. Paget disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing disease) no use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates no major surgery within 4 weeks of registration to protocol therapy no adjuvant chemotherapy within 6 months of registration to protocol therapy no previous chemotherapy for metastatic disease Participants randomized: 63 randomized, 32 intervention, 31 control Mean age: intervention: 70.5 years control: 71 years Country of participants: not clearly reported
Interventions	Previous interventions: not reported Interventions during study period: intervention: risedronate orally daily combined with androgen deprivation control: placebo orally daily combined with androgen deprivation
Outcomes	Reported and analyzed in this review: overall survival adverse events
Funding sources	Funding sources: support from the National Cancer Institute (USA)
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	Insufficient information on blinding of participants and personnel
Blinding of participants and personnel (performance bias) Blinding of personnel	Unclear risk	Placebo‐controlled trial, no further information
Blinding of outcome assessment (detection bias) Outcomes subjective to participants	Unclear risk	No information on blinding of outcome assessor
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	No known reason for bias
Incomplete outcome data (attrition bias) Time‐to‐event data	Unclear risk	Insufficient information on incomplete outcome data
Incomplete outcome data (attrition bias) Safety data	Unclear risk	Insufficient information on incomplete outcome data
Selective reporting (reporting bias)	Low risk	Protocol available (NCT00216060)
Other bias	Low risk	None identified