Clinical trial NCT00489424: 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
Official title: A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study of Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an i.v. Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: zoledronic acid
post dose symptoms
transient
acetaminophen
fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 793
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
timeFrame: 0 - 3 days
Secondary outcomes:
measure: Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.
timeFrame: 0 - 3 days
measure: Proportion of Patients Who Used Rescue Medication.
timeFrame: 0 - 3 days
measure: Number of Rescue Medication Tablets Taken
timeFrame: 0 - 3 days
measure: Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.
timeFrame: 0 - 3 days
measure: Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.
timeFrame: 0 - 3 days
measure: Proportion of Patients Reporting Severe Questionnaire Symptoms.
timeFrame: 0 - 3 days
measure: Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity
timeFrame: 0 - 3 days
Other outcomes:
Locations:
city: Http://www.osteoporosisclinicalresearch.com
country: United States
facility: Refer to the E-portal link for ZOL446HUS136
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: