Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Placebo; Acetaminophen; Fluvastatin
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 793.0
Sex: Female
Minimum age: 45 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: zoledronic acid; post dose symptoms; transient; acetaminophen; fluvastatin

Summary:

      This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of
      occurrence and the severity of post dose symptoms that may occur during the 3 day period
      following a zoledronic acid infusion in post menopausal women with low bone mass.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of
             age at randomization

          2. Women who are clinically indicated for treatment with Bisphosphonates for osteopenia
             or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score
             less than or equal to 1.5

        Exclusion Criteria:

          1. Any prior treatment with intravenous Bisphosphonates

          2. Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to
             the screening visit

          3. Patients who are taking, and are unwilling or unable to stop taking, certain
             medications

          4. Patients who require anticoagulant therapy

          5. Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or
             with allergies manifested by attacks of asthma, urticaria or acute rhinitis following

          6. Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at
             screening

          7. Protocol specific laboratory values that fall out of range for this study

          8. Ongoing infection (oral body temperature greater than or equal to 37.5C
             (99.5°F),chronic febrile disease or fever of unknown origin at screening or
             randomization

          9. Active dental infection, unhealed dental extraction or planned oral surgery within 3
             months after randomization

         10. History of iritis, uveitis or chronic conjunctivitis

         11. History of hypoparathyroidism, hyperparathyroidism or Paget's Disease

         12. Partial or total removal of parathyroid or thyroid gland

         13. History of malignancy of any organ system, treated or untreated, within the past 1
             year whether or not there is evidence of local recurrence or metastases, with the
             exception of localized basal cell carcinoma of the skin

         14. Treatment with an investigational drug within the previous 30 days of screening

         15. Patients with any medical or psychiatric condition which, in the opinion of the
             Principal Investigator, would preclude the participant from adhering to the protocol
             or completing the trial per protocol, or any patient who the Principal Investigator
             thinks should not participate in the study for any reason, including current drug or
             alcohol abuse

        Other protocol-defined inclusion/exclusion criteria may apply