A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Osteoporosis Clinical Trial

Official title:

A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100555
• Other study ID #: CZOL446H2315
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2005
• Last updated: April 26, 2012
• Start date: June 2004
• Est. completion date: June 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women between 45 and 79 years of age

• Must be osteopenic/osteoporotic

Exclusion Criteria:

• Any women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
United States	Deaconess Billings Clinic Research Division	Billings	Montana
United States	Univ. of Alabama/Division of Clinical Immunology and Rheumatology	Birmingham	Alabama
United States	Northwestern Center for Clinical Research	Chicago	Illinois
United States	Radiant Research	Dallas	Texas
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Univ. of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	Florida Medical Research Institute	Gainesville	Florida
United States	St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education	Houston	Texas
United States	The Arthritis Clinic of Jackson	Jackson	Tennessee
United States	Midwest Arthritis Center	Kalamazoo	Michigan
United States	Valley Medical Associates	Lewisburg	West Virginia
United States	Private Practice	Mayfield Village	Ohio
United States	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Women's Health Center	Salt Lake City	Utah
United States	Radiant Research	San DIego	California
United States	St. John's Medical Research	Springfield	Missouri
United States	Helen Hayes Hospital - Regional Bone Clinic	West Haverstraw	New York
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women
Secondary	To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
Secondary	To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
Secondary	To assess patient preferences for annual i.v. therapy compared to weekly oral therapy