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

Novartis

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Fluvastatin; Drug: Acetaminophen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489424

CZOL446HUS136

Details and patient eligibility

About

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.

Enrollment: 793 patients

Sex: Female

Ages: 45 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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793 participants in 3 patient groups, including a placebo group

Acetaminophen

Experimental group

Description:

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).

Treatment:

Drug: Acetaminophen

Fluvastatin

Experimental group

Description:

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).

Treatment:

Drug: Fluvastatin

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo