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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489424
• Other study ID #: CZOL446HUS136
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2007
• Last updated: February 15, 2011
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Placebo

• Acetaminophen

• Fluvastatin

Locations

Country	Name	City	State
United States	Refer to the E-portal link for ZOL446HUS136	Http://www.osteoporosisclinicalresearch.com	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.	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	No
Secondary	Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.	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	No
Secondary	Proportion of Patients Who Used Rescue Medication.	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	No
Secondary	Number of Rescue Medication Tablets Taken	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	No
Secondary	Time to First Rescue Medication After 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	No
Secondary	Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.	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	No
Secondary	Proportion of Patients Reporting Severe Questionnaire Symptoms.	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	No
Secondary	Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity	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	No