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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00100555
• Collaborator: (none)
• Enrollment: 120
• Locations: 18
• Duration (Months): 12
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: zoledronic acid	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 []

2. To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist []

3. To assess patient preferences for annual i.v. therapy compared to weekly oral therapy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 79 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ. of Alabama/Division of Clinical Immunology and Rheumatology	Birmingham	Alabama	United States	35294
2	Radiant Research	San DIego	California	United States	92108
3	Denver Arthritis Clinic	Denver	Colorado	United States	80230
4	Florida Medical Research Institute	Gainesville	Florida	United States	32605
5	Northwestern Center for Clinical Research	Chicago	Illinois	United States	60611
6	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
7	Midwest Arthritis Center	Kalamazoo	Michigan	United States	49048-1634
8	St. John's Medical Research	Springfield	Missouri	United States	65807
9	Deaconess Billings Clinic Research Division	Billings	Montana	United States	59101
10	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
11	Helen Hayes Hospital - Regional Bone Clinic	West Haverstraw	New York	United States	10993
12	Private Practice	Mayfield Village	Ohio	United States	44143
13	The Arthritis Clinic of Jackson	Jackson	Tennessee	United States	38305
14	Radiant Research	Dallas	Texas	United States	75235
15	Univ. of North Texas Health Science Center at Fort Worth	Fort Worth	Texas	United States	76107
16	St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education	Houston	Texas	United States	77030
17	Women's Health Center	Salt Lake City	Utah	United States	84117
18	Valley Medical Associates	Lewisburg	West Virginia	United States	24901

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00100555
• Other Study ID Numbers: CZOL446H2315
• First Posted: Jan 4, 2005
• Last Update Posted: Apr 27, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by , ,: Osteoporosis, osteopenia, post-menopausal, zoledronic acid
• Additional relevant MeSH terms: Osteoporosis; Zoledronic Acid

Study Results

No Results Posted as of Apr 27, 2012