Pravastatin Reduces Acute Phase Response of Zoledronic Acid
Postmenopausal Osteoporosis
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring acute phase response, zoledronic acid, pravastatin
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
pravastatin 80mg/d
placebo
Oral administration of pravastatin at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion
Oral administration of placebo at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion