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Zoledronic acid discontinuation safe for some women after 3 years
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Women who demonstrate a total hip T-score above –2.5 with no recent incident fracture and no more than one risk factor after 3 years on zoledronic acid are at low risk for subsequent fracture after stopping therapy, according to research in The Journal of Clinical Endocrinology & Metabolism.
Through a 3-year randomized multicenter extension of the HORIZON trial, Felicia Cosman, MD, of the Helen Hayes Hospital, West Haverstraw, N.Y., and colleagues from other institutions determined that treatment discontinuation for up to 3 years in this group is reasonable.
If treatment is discontinued, the average risk for subsequent fracture was 3.2% for morphometric vertebral fractures (MorphVertFx; range, 2.8%-3.8%) and 5.8% for nonvertebral fractures (NVF; range, 1.1%-8.8%) for subgroups, according to researchers.
The researchers looked at 1,233 women who received three annual zoledronic acid treatments during the core trial and had a hip measurement after the trial; 616 received three additional zoledronic acid infusions (Z6) and 617 placebo infusions (Z3P3).
Weight and hip bone mineral density were measured, and lateral thoracic and lumbar radiographs performed in all women at baseline. Prevalent vertebral fracture was determined by central radiological review at extension baseline. Based on core study events, incident MorphVertFx, NVF and changes in hip BMD and weight were calculated. The researchers assessed risk of MorphVertFx and clinical NVF.
Incidence of MorphVertFx in Z3P3 was predicted by femoral neck T-score ≤–2.5 (OR=3.3; 95% CI, 1.4-8), total hip T-score ≤–2.5 (OR=4; 95% CI, 1.8-9) and incident MorphVertFx during the core study (OR=4.75; 95% CI, 1.4-16.8).
Incidence of NVF was predicted by total hip T-score (for 1 decline, HR=1.7; 95% CI, 1.2-2.6), incident NVF during the core study (HR=2.5; 95% CI, 1.2-5.3) and prevalent vertebral fracture (HR=3; 95% CI, 1.4-6.3).
No significant treatment subgroup interactions were observed for MorphVertFx; most absolute fracture reductions with continued zoledronic acid were seen in high-risk subgroups. For NVF, no significant treatment reductions were seen overall or in subgroups; there were no significant interactions.
“Clearly, decisions to continue or stop [zoledronic acid] should be individualized and based on a comprehensive reassessment of fracture risk after the initial treatment period, including a fracture history and BMD test,” the researchers wrote.
Disclosure: Please see study for full list of disclosures.
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