- ICH GCP
- US Clinical Trials Registry
- 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
February 15, 2011 updated by: Novartis Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
793
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Http://www.osteoporosisclinicalresearch.com, New Jersey, United States
- Refer to the E-portal link for ZOL446HUS136
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
- 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:
- Any prior treatment with intravenous Bisphosphonates
- Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
- Patients who are taking, and are unwilling or unable to stop taking, certain medications
- Patients who require anticoagulant therapy
- Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
- Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
- Protocol specific laboratory values that fall out of range for this study
- 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
- Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
- History of iritis, uveitis or chronic conjunctivitis
- History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
- Partial or total removal of parathyroid or thyroid gland
- 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
- Treatment with an investigational drug within the previous 30 days of screening
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acetaminophen
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v.
infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
|
|
Experimental: Fluvastatin
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v.
infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
|
|
Placebo Comparator: Placebo
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
Time Frame: 0 - 3 days
|
Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
|
0 - 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.
Time Frame: 0 - 3 days
|
Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
|
0 - 3 days
|
Proportion of Patients Who Used Rescue Medication.
Time Frame: 0 - 3 days
|
Patients that took rescue medication >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
|
0 - 3 days
|
Number of Rescue Medication Tablets Taken
Time Frame: 0 - 3 days
|
Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
|
0 - 3 days
|
Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.
Time Frame: 0 - 3 days
|
Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
|
0 - 3 days
|
Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.
Time Frame: 0 - 3 days
|
A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v.
infusion of zoledronic acid 5 mg.
The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
|
0 - 3 days
|
Proportion of Patients Reporting Severe Questionnaire Symptoms.
Time Frame: 0 - 3 days
|
A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.
|
0 - 3 days
|
Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity
Time Frame: 0 - 3 days
|
Effect on severity of symptoms following i.v.
infusion of zoledronic acid 5 mg.
The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms).
The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.
|
0 - 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Estimate)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 15, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZOL446HUS136
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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