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 ID: NCT00489424

Last Updated: 2011-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 793 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

Fluvastatin

Intervention Type: DRUG

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

Acetaminophen

Intervention Type: DRUG

Fluvastatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Refer to the E-portal link for ZOL446HUS136

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

Countries

United States

Related Links

http://www.osteoporosisclinicalresearch.com

Click here for more information on this study

Other Identifiers

CZOL446HUS136

Identifier Type: -

Identifier Source: org_study_id