ACTIVE 2016.
| Study characteristics | ||
| Methods |
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| Participants |
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| Interventions | Treatment group
Control group 1
Control group 2 (active comparator)
Co‐interventions
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| Outcomes | Primary outcome
Secondary outcomes
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| Notes |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly assigned to each treatment groups by means of a central, interactive, automated telephone system |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed because participants were assigned to each group using a central, interactive, automated telephone system |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Active comparator (teriparatide) could not be repackaged and blinded. However, the comparison between abaloparatide and placebo, which was main purpose of this study, could be blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Efficacy and safety outcomes were assessed by blinded and independent assessors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing outcome data were balanced in numbers across intervention groups; however, the reasons for missing data were not stated |
| Selective reporting (reporting bias) | High risk | All predefined efficacy and safety outcomes were reported, however BMD was reported incompletely so that these data could not be entered in a meta‐analysis (no control group data) |
| Other bias | High risk | The study was funded by Radius Health |