Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05
Primary result · Morphometric vertebral fractureResult — go to the resultRate ratio 0.69 95% CI 0.54–0.88Authors' conclusion
Once-weekly injection of teriparatide, followed by alendronate resulted in a significantly lower incidence of morphometric vertebral fracture than alendronate monotherapy in women with osteoporosis who were at high risk of fracture.
Study context
- Population
- Japanese women aged at least 75 years with primary osteoporosis at high risk of fracture489 and 496 in main analysis
- Participants
- 505 vs 506
- Comparison
- Once-weekly SC teriparatide 56.5 μg for 72 weeks, then alendronate for 48 weeks, vs alendronate monotherapy for 120 weeks
- Sequential therapyn = 505
- Monotherapyn = 506reference
- Primary endpoint
- Incidence of morphometric vertebral fracture
- Follow-up
- 120 weeks
Methodological detailsprospective, open-label, blinded-endpoint, Enrolment October 2014 to June 2020
- Prospective
- Open-label
- Blinded-endpoint
- Enrolment October 2014 to June 2020
Primary result
Morphometric vertebral fracture
Rate ratio
0.69
95% CI 0.54–0.88
P < 0.01
Events by treatment group
Sequential therapy
0.1020
64 of 505
Monotherapy
0.1492
126 of 506
Sequential therapyvs Monotherapy
rate ratio 0.69 (95% CI 0.54–0.88); P < 0.01
As reported in the abstract
Safety
Severe adverse events considered related to study drug · after 72 weeks
- No patient had a severe drug-related adverse event
Original publication
Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05. Osteoporos Int. Published 14 October 2022. doi:10.
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