Duration of fracture prevention after zoledronate treatment in women with osteopenia: observational follow-up of a 6-year randomised controlled trial to 10 years
Authors' conclusion
The reduced fracture rates following zoledronate in the core trial were substantially maintained for 1.5-3.5 years after the last zoledronate infusion, but not thereafter.
Study context
- Population
- Ambulant, community-dwelling postmenopausal women >65 years with osteopenia (total hip or femoral neck T-score −1.0 to −2.5), Auckland, New Zealand, who received zoledronate and completed the 6-year core trial727 assessed at 10 years
- Participants
- 762 participants
- Outcome
- Non-vertebral fracture rates
- Follow-up
- Years 6–10
Methodological details4-year observational extension, single-group, Entered extension Sept 24, 2015, to Dec 13, 2017; final follow-up May 25, 2022
- 4-year observational extension
- Single-group
- Entered extension Sept 24, 2015, to Dec 13, 2017; final follow-up May 25, 2022
Main finding
As reported in the abstract
Last 2 years of core trial (nadir)
15 fractures per 1000 woman-years (95% CI 10-21)
Years 6-8
24 fractures
17–33
Years 8-10, similar to placebo in last 2 years of core trial
42 fractures
32–53
Women with non-vertebral fractures during extension
92 women suffered 114 non-vertebral fractures
Observational data: associations, not effects.
Further findings
Predictors of incident fracture at year 6
- Total hip bone mineral density (BMD), RR per 0.1 g/cm²
- 0.73, 95% CI 0.57-0.93; p=0.011
- Previous non-vertebral fracture
- 1.74, 1.12-2.69; p=0.013
- Change in total hip BMD did not predict fractures
Total hip BMD vs study baseline · years 6–10
- Decreased from 4.2% above to 0.8% above baseline
- P < 0.0001
Turnover markers · year 10
- Not useful for predicting BMD loss in individuals
- Random subset of 50 participants
Deaths and withdrawals
- Died
- 25
- Withdrew for medical reasons
- 6
- Lost to follow-up
- 4
Safety
Osteonecrosis of the jaw or atypical femoral fractures · extension (years 6–10)
- Osteonecrosis of the jaw or atypical femoral fractures did not occur in any participants
Original publication
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