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Irrespective
of the timing, ZOL (Zoledronate) treatment is not sufficient to completely
prevent loss of BMD (bone mineral density) in patients discontinuing DMAB
(Denosumab).
A recent study demonstrated that in patients discontinuing DMAB after 4.6±1.6 years, a subsequent single infusion of 5 mg ZOL given six or nine months after the last DMAB injection or when bone turnover was increased, did not fully prevent increases in bone turnover and bone loss.
This
randomized, open-label, interventional study aimed to investigate if treatment
with ZOL could prevent increases in bone turnover and bone loss in patients
previously treated with DMAB. It also determined if the timing of the
administration after the last injection of DMAB influenced the outcome effect
of ZOL.
The
study included 61 participants with osteopenia who discontinued long-term
treatment with DMAB to ZOL at three different intervals after the last DMAB
injection. 59 patients completed the follow-up period. Patients were randomly
assigned to receive ZOL six (6M group, n=20) or nine months (9M group, n=20)
after the last DMAB injection or when bone turnover had increased (OBS;
Observation group, n=21).
Using
DXA (dual-energy x-ray absorptiometry) and bone turnover markers, the patients
were monitored. The primary endpoints were changes in LSBMD (lumbar spine bone
mineral density) six months after ZOL and the proportion of patients who failed
to maintain BMD.
Six
months after ZOL, LSBMD had decreased significantly by 2.1±0.9% (mean ± SEM),
4.3±1.1% and 3.0±1.1% in the 6M, 9M and OBS groups, respectively. 12 months
after ZOL, LSBMD reduced by 4.8±0.7%, 4.1±1.1%, and 4.7±1.2% in the 6M, 9M, and
OBS groups, respectively as depicted in Table 1:
In all groups, BMD loss above the least significant change was witnessed: At the spine: 6M:n=6 (30%), 9M: n=9 (45%), OBS: n= 9 (47%). At the total hip, the values were: 6M: n=1 (5%), 9M: n=5 (25%), OBS: n=2 (11%) as depicted in Table 2:
In
the 6M group, p-CTX (p-cross-linked C-terminal telopeptide) declined initially
but rapidly elevated thereafter. Six months after ZOL, p-CTX was 0.60±0.08
g/L. In the 9M and OBS groups, p-CTX
elevated rapidly. It was suppressed by ZOL but elevated again thereafter; p-CTX
was 0.47±0.05 μg/L and 0.47±0.05 μg/L six months after ZOL, respectively. In
the 9M group, incident vertebral fractures were observed in two women. Thus,
ZOL treatment cannot fully prevent the loss of BMD in patients discontinuing
DMAB.
Journal of Bone and Mineral Research
Treatment with zoledronate subsequent to denosumab in osteoporosis: a randomized trial
Anne Sophie Solling et al.
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