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Pravastatin Reduces Acute Phase Response of Zoledronic Acid

NCT04719481 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-06-23

No results posted yet for this study

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

  • Postmenopausal Osteoporosis

Interventions

DRUG

Pravastatin Sodium 80 MG

daily oral administration of 80mg

DRUG

Placebo

daily oral administration

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Chunli Song, M.D.; Ph. D. · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2021-11-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719481 on ClinicalTrials.gov