Study designs of evaluations included in the review
Blinded randomised controlled trials (RCTs) with at least 30 months' observational follow-up were eligible for inclusion (observation in the follow-up phase was not blinded).
Specific interventions included in the review
Studies that compared teriparatide with placebo or another comparator were eligible for inclusion. The included studies compared teriparatide (20 or 40 microg/day) with placebo, alendronate (10 mg/day) or hormone replacement therapy. All participants received calcium and vitamin D supplementation. During the follow-up phase approximately 55% of the participants who received teriparatide in the trials were treated with another osteoporosis treatment, compared with approximately 64% of those who had received the comparator.
Participants included in the review
Studies in people with osteoporosis, who were free of other chronic conditions, were eligible for inclusion. The included studies enrolled either men or women but not both; approximately 80% of the participants overall were women. The mean age in the study groups ranged from 57.6 years (standard deviation, SD=13.2) to 69.4 years (SD=6.8).
Outcomes assessed in the review
The primary outcome in the included studies was vertebral fracture or bone mineral density, but the outcome assessed in this review was back pain observed during follow-up. The median follow-up in the included studies ranged from 29.7 to 30.4 months (the lowest interquartile range limit was 28.7 and the highest 31.7). Back pain was self-reported by the participants (study investigators systematically monitored adverse events during follow-up without specifically enquiring about back pain). Back pain severity was categorised as mild, moderate or severe (defined in the report).
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.