Barreira 2009.
Methods | RCT. Randomisation ratio: 1:2 (pamidronate: olpadronate). Superiority design |
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Participants |
Diagnostic criteria: Not stated. Inclusion criteria: active Paget's disease of bone despite previous therapies. Exclusion criteria: not stated. Number screened: not stated. Number randomised: 27. Number analysed: 21 (age and sex not stated; percentages monostotic, symptomatic and previously treated for Paget's disease of bone were not stated) |
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Interventions | Two parallel treatment groups; pamidronate 400 mg/day for 4 months vs. olpadronate 200 mg/day for 12 days. Co‐interventions: Not reported |
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Outcomes |
Outcomes reported in abstract Primary endpoint: Mean percentage change from baseline in serum total alkaline phosphatase activity. Secondary endpoints: Number of participants who experienced adverse events related to use of bisphosphonates. Time points for measurement: 6 months. How were the outcomes were measured: Insufficient information. Likely prospectively |
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Setting and date | Multicentre; Argentina. Period when the study was conducted: Not stated |
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Follow up period | 6 months | |
Publication details and funding source |
Language of publication: English.
Publication status: conference abstracts only. Funding source: Not stated. Declarations of interest among primary researchers: Not stated |
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Notes | Data only from abstracts | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized in a 1:2 schedule." Randomisation method not reported |
Allocation concealment (selection bias) | Unclear risk | Randomisation method not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both formulations were double dummy with placebos" Comment: Probably done. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to permit judgement. Only an abstract of the trials was published. Many data were lacking; there were no data on attrition, exclusions or adverse events |
Selective reporting (reporting bias) | Unclear risk | Insufficient reporting to permit judgement. Methods and results sections were poorly described. It was not possible to assess if they were consistent. We did not have access to a trial register record or study protocol to know if there was a prespecified record of the studies outcomes |
Other bias | Unclear risk | There were no data on exposure to co‐interventions other than bisphosphonates. No other risks of bias found, but reporting was insufficient to permit judgement. |