Zoledronate Sequential Therapy After Denosumab Discontinuation to Prevent Bone Mineral Density Reduction: A Randomized Clinical Trial
Authors' conclusion
In this randomized trial of sequential therapy after denosumab discontinuation, bone loss was observed in LS-BMD in the first year among patients receiving zoledronate. A longer duration of denosumab treatment was associated with a further decrease in LS-BMD after zoledronate sequential therapy.
Study context
- Population
- Postmenopausal women and men aged ≥50 years on regular denosumab for ≥2 years without previous other antiosteoporosis medication; referral center and 2 affiliated hospitals in Taiwan95 women [94.1%]
- Participants
- 101 participants
- Comparison
- Zoledronate 5 mg single dose vs continuous denosumab after regular denosumab treatment
- ZOLn = 76
- An = 25reference
- Primary endpoint
- Co-primary: Bone mineral density (BMD) percentage changes in lumbar spine (LS-BMD), total hip (TH-BMD) and femoral neck (FN-BMD)
- Follow-up
- First year
Methodological detailsprospective, open-label, parallel-group, stratified randomization, multicentre, Recruitment April 1, 2019, to May 31, 2021; 2-year follow-up planned
- Prospective
- Open-label
- Parallel-group
- Stratified randomization
- Multicentre
- Recruitment April 1, 2019, to May 31, 2021; 2-year follow-up planned
Primary result
As reported in the abstract
LS-BMD percentage change
ZOL
−0.68%
median · IQR −3.22%–2.75%
A
1.30%
median · IQR −0.68%–5.24%
P = 0.03
Further findings
Median
| Outcome | ZOL | A | P value |
|---|---|---|---|
| Co-primary: TH-BMD percentage change · first yearIntention-to-treat | 0% (IQR −1.47%–2.15%) | 1.12% (IQR −0.06%–2.25%) | P = 0.24 |
| Co-primary: FN-BMD percentage change · first yearIntention-to-treat | 0.18% (IQR −2.73%–3.88%) | 0.17% (IQR −2.29%–2.90%) | P = 0.71 |
| LS-BMD percentage change, ZOL subgroup with ≥3 years of prior denosumab · first year | −3.20% (IQR −7.89%–0.68%) | — not stated in the abstract | P = 0.003 |
— not stated in the abstract
Original publication
Zoledronate Sequential Therapy After Denosumab Discontinuation to Prevent Bone Mineral Density Reduction: A Randomized Clinical Trial. JAMA Netw Open. Published 4 November 2024. doi:10.
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