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

This study has been completed.

Study NCT00489424 Information provided by Novartis

First Received on June 19, 2007. Last Updated on February 15, 2011 History of Changes

Results First Received: August 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Osteoporosis
Interventions:	Drug: Placebo Drug: Acetaminophen Drug: Fluvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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).
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).
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).

Participant Flow: Overall Study

	Placebo	Acetaminophen	Fluvastatin
STARTED	267	264	262
COMPLETED	263	259	257
NOT COMPLETED	4	5	5
Adverse Event	3	3	4
Lack of Efficacy	1	0	0
Administrative problems	0	2	1

Baseline Characteristics

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Reporting Groups

	Description
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).
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).
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).

Baseline Measures

	Placebo	Acetaminophen	Fluvastatin	Total
Number of Participants [units: participants]	267	264	262	793
Age, Customized [units: participants]
Between 45 and 55 years	64	69	67	200
Between 56 and 64 years	102	98	92	292
>=65 years	101	97	103	301
Gender, Customized [units: participants]
Female	267	264	262	793

Outcome Measures

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1. Primary:

Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication. [ Time Frame: 0 - 3 days ]

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2. Secondary:

Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature. [ Time Frame: 0 - 3 days ]

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3. Secondary:

Proportion of Patients Who Used Rescue Medication. [ Time Frame: 0 - 3 days ]

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4. Secondary:

Number of Rescue Medication Tablets Taken [ Time Frame: 0 - 3 days ]

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5. Secondary:

Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg. [ Time Frame: 0 - 3 days ]

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6. Secondary:

Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms. [ Time Frame: 0 - 3 days ]

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7. Secondary:

Proportion of Patients Reporting Severe Questionnaire Symptoms. [ Time Frame: 0 - 3 days ]

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8. Secondary:

Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity [ Time Frame: 0 - 3 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00489424 History of Changes
Other Study ID Numbers:	CZOL446HUS136
Study First Received:	June 19, 2007
Results First Received:	August 6, 2009
Last Updated:	February 15, 2011
Health Authority:	United States: Food and Drug Administration