Clinical Outcome of Zoledronic Acid Combined with Percutaneous Kyphoplasty in the Treatment of T12 or L1 OVCF
Introduction
Zoledronic acid (ZOL) is a nitrogen-containing bisphosphonate which is known to increase bone mineral density (BMD) and decrease the risk of osteoporotic fracture.
Aim
To investigate and analyze the clinical effects of zoledronic acid (ZOL) in combination with percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fracture (OVCF) in postmenopausal women
Patient Profile
Postmenopausal women patients with T12 or L1 OVCF
Methods
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Prospective study
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101 Postmenopausal women patients with T12 or L1 OVCF who received PKP were randomly assigned to -
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Zoledronic acid (ZOL) group (n = 50) or
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Control group (n = 51)
Treatment
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ZOL Group: Patients were treated preoperatively with IV infusion of 5 mg ZOL in combination with 0.25 µg/d calcitriol and 600 mg/d calcium carbonate for a year.
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Control Group: Patients were treated with the same dose of calcitriol and calcium carbonate D3 without ZOL.
The BMD value, serum bone metabolic indices, VAS score, and adverse reactions were evaluated.
Results
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BMD in ZOL group was significantly higher at 6 and 12 months compared to control group (p<0.01)
Figure 1: BMD of left femoral neck after PKP, with or without ZOL infusion, at baseline, post 6 months and 12 months
*p < 0.01 6 ZOL group vs. control group months after treatment
# p< 0.001, ZOL group vs. control group 12 months after treatment
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Bone markers N terminal molecular fragment (NMID), the total extension of
the peptide type I collagen amino end (P1NP), and beta collagendegradation product (ß-CTX) in ZOL group were significantly lower than those in the control group
Table 1: Bone markers NMID, P1NP, and ß-CTX after PKP and/ or ZOL infusion
|
|
Baseline |
At 6 months |
At 12 months |
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|
|
NMID |
P1NP |
ß-CTX |
NMID |
P1NP |
ß-CTX |
NMID |
P1NP |
ß-CTX |
|
ZOL Group |
20.76 ± 6.88 µg/L |
39.98 ± 1.79 µg/L |
0.55 ± 0.14 µg/L
|
15.08 ± 5.56 µg/L |
15.37 ± 1.61 µg/L
|
0.35 ± 0.04 µg/L |
13.94 ± 2.79 µg/L |
15.40 ± 1.40 µg/L |
0.34 ± 0.05 µg/L |
|
Control Group |
22.43 ± 5.58 µg/L |
39.96 ± 1.90 µg/L |
0.56 ± 0.14 µg/L |
18.81 ± 5.05 µg/L |
33.13 ± 1.30 µg/L |
0.42 ± 0.18 µg/L
|
17.88 ± 4.25 µg/L |
33.23 ± 1.94 µg/L |
0.40 ± 0.06 μg/L |
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VAS score in ZOL group was significantly lower than that in the control group 1 week, 6 months, and 12 months after treatment.
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No new fracture occurred in ZOL group
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Incidence of recompression vertebral fracture (RVF)
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Control group = 11.7%
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ZOL group - no RVF detected
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In ZOL group, adverse events occurred after IV infusion of ZOL in 36% cases, including fever (55.6%), flu like symptoms (16.7%), arthralgia (16.7%) and myalgia (11.1%)
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All AE in ZOL group were mild and cured after symptomatic treatment
Conclusion
ZOL IV infusion in combination with PKP in the treatment of T12 or L1 OVCF could effectively improve the patients’ BMD, improve bone marker levels, and reduce the VAS score and RVF with a low rate of acceptable adverse reactions and relatively low economic pressure.
Reference
Osteoporos Int. 2019 Jul;30(7):1475-1480.
