Acute phase response (APR) is one of the most common adverse events in osteoporosis with zoledronic acid treatment. It's reported that this reaction is related to the blockade of the mevalonate pathway, leading to isopentenyl pyrophosphate (IPP) accumulation. And the latter can active γδT cells in the circulation, resulting in inflammatory cytokine release. Statins can inhibit the conversion of HMG-CoA to mevalonate that may reduce the accumulation of IPP. Therefore, it is possible that statins can be taken in advance to reduce APR caused by zoledronic acid infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
daily oral administration of 80mg
daily oral administration
Incidence of acute phase response
Effect of oral pravastatin on the incidence of acute phase response within 72 hours after zoledronic acid infusion
Time frame: 0-72 hours
Occurrence time of fever
Effect of oral pravastatin on the occurrence time of fever after zoledronic acid infusion
Time frame: from 8:00 a.m. to 8:00 p.m. with interval of 4 hours in Day -2 and Day -1, from 9:00 a.m. to 9:00 p.m. with interval of 3 hours in Day 0, 1, 2, 3. It should be recorded when fever occurs in other time.
Severity of fever
Effect of oral pravastatin on the severity of fever (body temperature) after zoledronic acid infusion.
Time frame: from 8:00 a.m. to 8:00 p.m. with interval of 4 hours in Day -2 and Day -1, from 9:00 a.m. to 9:00 p.m. with interval of 3 hours in Day 0, 1, 2, 3. It should be recorded when fever occurs in other time.
Occurrence time of pain
Effect of oral pravastatin on the occurrence time of pain after zoledronic acid infusion
Time frame: from 8:00 a.m. to 8:00 p.m. with interval of 4 hours in Day -2 and Day -1, from 9:00 a.m. to 9:00 p.m. with interval of 3 hours in Day 0, 1, 2, 3. It should be recorded when pain occurs in other time.
Severity of pain
Effect of oral pravastatin on the severity of pain (visual analogue scale, VAS) after zoledronic acid infusion
Time frame: from 8:00 a.m. to 8:00 p.m. with interval of 4 hours in Day -2 and Day -1, from 9:00 a.m. to 9:00 p.m. with interval of 3 hours in Day 0, 1, 2, 3. It should be recorded when pain occurs in other time.
Frequency of acetaminophen usage after zoledronic acid infusion
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To compare the frequency of acetaminophen within 72 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: within 72 hours after zoledronic acid infusion
Amount of acetaminophen usage after zoledronic acid infusion
To compare the amount of acetaminophen within 72 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: within 72 hours after zoledronic acid infusion
White blood cells
To compare the changes in white blood cells (WBC) count within 48 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: baseline and 48 hours after infusion
C reaction protein
To compare the changes in C reaction protein (CRP) within 48 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: baseline and 48 hours after infusion
interferon-γ expression
To compare the changes in interferon-γ (IFN-γ) within 48 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: baseline and 48 hours after infusion
interleukin-6 expression
To compare the changes in interleukin-6 (IL-6) within 48 hours after zoledronic acid infusion between pravastatin arm and placebo arm.
Time frame: baseline and 48 hours after infusion
γδT cells activation
To compare the changes in count of γδT cells activation within 48 hours after zoledronic acid infusion pravastatin arm and placebo arm.
Time frame: baseline and 48 hours after infusion
Adverse event occurrence
The occurrence of adverse event within 10 days after zoledronic acid infusion
Time frame: 0-10 days