Official Title: “A Multi-Center, Randomized, Double-Blind, Double-Dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg Once Daily on Bone Turnover Markers”

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Placebo and raloxifene
• Drug: zoledronic acid and placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• change from baseline in urine N-telopeptide of Type 1 collagen (NTx) at 6 months

Secondary Measures

• change from baseline in urine NTx at 2 and 4 months and bone specific alkaline phosphatase (BSAP) at 2, 4 and 6 months
• Overall physician, nurse and patient satisfaction with Satisfaction Questionnaire
• Patient preference at 6 months for annual i.v therapy or daily oral regimens

Inclusion Criteria:

• Females between the ages of 45 and 80
• Post-menopausal - ~no menses for 18 months if less than 50 years of age - ~no menses for 12 months if more than 50 years of age
• DEXA scan T-score of less than or equal to -1.5

Exclusion Criteria:

• Previous treatment with i.v. or oral bisphosphonates within the last 2 years
• Treatment with the following drugs within 6 months of study start: raloxifene, calcitonin, tibolone or hormone replacement therapy
• Treatment with the following drugs: strontium renalate, sodium fluoride or parathyroid hormone

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Overall Contact: Novartis Pharmaceuticals 862 778 8300 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431444

Study ID Number: CZOL446HUS121

ClinicalTrials.gov Identifier: NCT00431444

Health Authority: United States: Food and Drug Administration