Pravastatin Reduces Acute Phase Response of Zoledronic Acid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pravastatin 80mg/d

Oral administration of pravastatin at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion

Group Type EXPERIMENTAL

Pravastatin Sodium 80 MG

Intervention Type DRUG

daily oral administration of 80mg

placebo

Oral administration of placebo at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

daily oral administration

Interventions

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Pravastatin Sodium 80 MG

daily oral administration of 80mg

Intervention Type DRUG

Placebo

daily oral administration

Intervention Type DRUG

Other Intervention Names

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Meibailezhen Meibailezhen placebo

Eligibility Criteria

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Inclusion Criteria

1. Chinese Han ethnic postmenopausal women.
2. Bone mineral density values of less than 2.5 standard deviations (SD) below the normal adult mean.
3. Willing to participate in this study.

Exclusion Criteria

1. Prior treatment with biphosphonates (oral or intravenous).
2. Fever and/or any viral or bacterial infections within 30 days prior to randomization.
3. Patients with evidence of any cancer or with a history of cancer.
4. Contraindication to zoledronic acid:

Known hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients); Serum calcium level \< 2.13 mmol/L (8.5 mg/dL), free serum calcium level \<0.95 mmol/L (3.8 mg/dL) or untreated hypocalcemia; Childbearing or child-breastfeeding women; Creatinine clearance \< 35 mL/min;

Restrictions:

Patients currently receiving aminoglycoside, diuretics or thalidomide.
5. Contraindication to pravastatin:

Known hypersensitivity to pravastatin or other excipients in pravastatin sodium formulation.

Restrictions:

Patients with severe liver insufficiency, history of severe liver insufficiency, active liver disease or continuously elevated transaminase; Patients with severe renal insufficiency or history of severe renal insufficiency; Patients currently receiving fibrates (e.g., bezafibrate), immunosuppressive drug (e.g., cyclosporine) or niacin.
6. Any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes