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NCT Number: 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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Refer to the E-portal link for ZOL446HUS136

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Acetaminophen

Drug

Fluvastatin

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 21, 2007
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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