Trials / Unknown
UnknownNCT04719481
Pravastatin Reduces Acute Phase Response of Zoledronic Acid
The Reduction Effect of Oral Pravastatin on Acute Phase Response of Intravenous Zoledronic Acid: a Real-world Study
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Peking University Third Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pravastatin Sodium 80 MG | daily oral administration of 80mg |
| DRUG | Placebo | daily oral administration |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2021-11-01
- Completion
- 2022-04-01
- First posted
- 2021-01-22
- Last updated
- 2021-06-23
Source: ClinicalTrials.gov record NCT04719481. Inclusion in this directory is not an endorsement.