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

NCT00489424, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2009-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT00489424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489424

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT00489424
Status: Completed
Phases: Phase 4
Enrollment: 793 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Osteoporosis
Interventions: Placebo, Acetaminophen, Fluvastatin
First posted: 2007-06-21
Last updated: 2011-02-18
Results first posted: 2009-09-14

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	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.
Secondary	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	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.
Secondary	Proportion of Patients Who Used Rescue Medication.	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.
Secondary	Number of Rescue Medication Tablets Taken	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.
Secondary	Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.	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.
Secondary	Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.	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).
Secondary	Proportion of Patients Reporting Severe Questionnaire Symptoms.	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.
Secondary	Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	0 - 3 days	Intent to Treat (ITT) population.	proportion of patients	NUMBER
SECONDARY	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	0 - 3 days	Intent to Treat (ITT) population.	proportion of patients	NUMBER
SECONDARY	Proportion of Patients Who Used Rescue Medication.	0 - 3 days	Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.	proportion of patients	NUMBER
SECONDARY	Number of Rescue Medication Tablets Taken	0 - 3 days	Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.	tablets	MEAN
SECONDARY	Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.	0 - 3 days	Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.	hours	MEAN
SECONDARY	Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.	0 - 3 days	Intent to Treat (ITT) population.	proportion of patients	NUMBER
SECONDARY	Proportion of Patients Reporting Severe Questionnaire Symptoms.	0 - 3 days	Intent to Treat (ITT) population.	proportion of patients	NUMBER
SECONDARY	Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity	0 - 3 days	Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group51

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Placebo	Increase in oral body temperature:Yes	0.607	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Acetaminophen	Increase in oral body temperature:Yes	0.398	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Fluvastatin	Increase in oral body temperature:Yes	0.618	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Placebo	Increase in oral body temperature:No	0.39	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Acetaminophen	Increase in oral body temperature:No	0.602	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	Fluvastatin	Increase in oral body temperature:No	0.382	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	Placebo	Increase in oral body temperature: Yes	0.105	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	Acetaminophen	Increase in oral body temperature: Yes	0.049	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	Fluvastatin	Increase in oral body temperature: Yes	0.115	proportion of patients
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	Placebo	Increase in oral body temperature: No	0.891	proportion of patients

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	267
Overall Study	STARTED	Acetaminophen	264
Overall Study	STARTED	Fluvastatin	262
Overall Study	COMPLETED	Placebo	263
Overall Study	COMPLETED	Acetaminophen	259
Overall Study	COMPLETED	Fluvastatin	257
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Acetaminophen	5
Overall Study	NOT COMPLETED	Fluvastatin	5

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Placebo	7	267
other	Nausea	Gastrointestinal disorders	Acetaminophen	16	264
other	Nausea	Gastrointestinal disorders	Fluvastatin	8	262
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	13	267
other	Arthralgia	Musculoskeletal and connective tissue disorders	Acetaminophen	9	264
other	Arthralgia	Musculoskeletal and connective tissue disorders	Fluvastatin	14	262
other	Myalgia	Musculoskeletal and connective tissue disorders	Placebo	14	267
other	Myalgia	Musculoskeletal and connective tissue disorders	Acetaminophen	11	264
other	Myalgia	Musculoskeletal and connective tissue disorders	Fluvastatin	10	262
other	Headache	Nervous system disorders	Placebo	8	267

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Acetaminophen
Total, all-cause mortality	Fluvastatin
Total, other adverse events	Placebo	34	267
Total, other adverse events	Acetaminophen	39	264
Total, other adverse events	Fluvastatin	36	262
Total, serious adverse events	Placebo	1	267
Total, serious adverse events	Acetaminophen	2	264
Total, serious adverse events	Fluvastatin	2	262

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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