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

Wang 2013.

Study characteristics
Methods Recruitment period:
  • July 2008 to March 2010


Outcomes:
  • Bone PFS, overall survival, bone mineral density, SREs, VAS scores for pain relief, analgesic use, toxicity and adverse events


Pain assessment tool:
  • VAS


Randomization:
  • "eligible patients are randomly divided into two groups"

Participants Eligibility criteria:
  • patients’ > 18 years with life expectancy of > 6 months

  • patients with histologically confirmed prostate cancer, with at least 2 radiographic (ECT and CT or MRI) evidences of bone metastases

  • patients were required to have castrated level of PSA (< 2 ng/mL), achieved by bilateral orchidectomy or administration of a luteinizing‐hormone releasing hormone agonist


Exclusion criteria:
  • patients with significant renal, hepatic, or non‐malignant‐related diseases

  • previous radical prostatectomy, chemotherapy, or radiotherapy

  • previous use of bisphosphates and calcium supplement

  • Paget’s diseases, primary hyperparathyroidism, or osteoporosis


Participants randomized:
  • 137 randomized, 69 zoledronic acid, 68 clodronate


Mean age:
  • 71.3 zoledronic acid group

  • 73.6 clodronate group


Country of participants:
  • China

Interventions Previous interventions:
  • not mentioned


Interventions during study period:
  • all participants received a calcium supplement of 500 mg and vitamin D of 400 IU daily; participants received either 4 tablets of clodronate (1600 mg) once daily, at least 1 h before breakfast, or zoledronic acid 4 mg over a 30 min IV infusion) every 1 month

Outcomes Reported and analyzed in this review:
  • SREs

  • adverse events

  • overall survival

  • pain relief

Funding sources Funding sources:
  • Wenzhou science technology bureau (Y20100023)

Declarations of interest Conflicts of interest:
  • all authors state that they have no conflict of interest

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 Insufficient information on blinding of participants and personnel
Blinding of outcome assessment (detection bias)
Outcomes subjective to participants Unclear risk Insufficient information on blinding of participants and personnel
Blinding of outcome assessment (detection bias)
Outcomes subjective to outcome assessors Unclear risk Insufficient information on blinding of outcome assessors
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk No known reason for bias
Incomplete outcome data (attrition bias)
Time‐to‐event data Low risk "All the recruited patients were evaluated for the efficacy and safety every 1 month until death." Intention‐to‐treat‐analysis was used.
Incomplete outcome data (attrition bias)
Patient‐reported outcomes (other than safety data) Unclear risk "All the recruited patients were evaluated for the efficacy and safety every 1 month until death." No information on discontinuation
Incomplete outcome data (attrition bias)
Safety data Unclear risk "All the recruited patients were evaluated for the efficacy and safety every 1 month until death." No information on discontinuation
Incomplete outcome data (attrition bias)
Other outcomes Unclear risk "All the recruited patients were evaluated for the efficacy and safety every 1 month until death." No information on discontinuation
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk None identified