Status:
UNKNOWN
Pravastatin Reduces Acute Phase Response of Zoledronic Acid
Lead Sponsor:
Peking University Third Hospital
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE4
Brief 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 pathwa...
Eligibility Criteria
Inclusion
- Chinese Han ethnic postmenopausal women.
- Bone mineral density values of less than 2.5 standard deviations (SD) below the normal adult mean.
- Willing to participate in this study.
Exclusion
- Prior treatment with biphosphonates (oral or intravenous).
- Fever and/or any viral or bacterial infections within 30 days prior to randomization.
- Patients with evidence of any cancer or with a history of cancer.
- 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.
- 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.
- Any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04719481
Start Date
November 1 2021
End Date
April 1 2022
Last Update
June 23 2021
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