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 | Completed Phase 4 Results

• 1 other identifier: CZOL446HUS136
• Study Type: interventional
• Target: 793
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

zoledronic acid; post dose symptoms; transient; acetaminophen; fluvastatin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.

  0 - 3 days

• Proportion of Patients Who Used Rescue Medication.

  0 - 3 days

• Number of Rescue Medication Tablets Taken

  0 - 3 days

• Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.

  0 - 3 days

• Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.

  0 - 3 days

Study Arms (3)

Acetaminophen

EXPERIMENTAL

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).

Drug: Acetaminophen

Fluvastatin

EXPERIMENTAL

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).

Drug: Fluvastatin

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Acetaminophen DRUG

Acetaminophen

Fluvastatin DRUG

Fluvastatin

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Refer to the E-portal link for ZOL446HUS136

Http://www.osteoporosisclinicalresearch.com, New Jersey, United States

Location

Related Links

• Click here for more information on this study

MeSH Terms

Conditions

Osteoporosis

Interventions

Acetaminophen; Fluvastatin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 21, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 18, 2011
• Results First Posted: September 14, 2009

Record last verified: 2011-02

Locations

US (1)