Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00097812
• Collaborator: (none)
• Enrollment: 220
• Locations: 13
• Duration (Months): 19
• Patients Per Site: 16.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

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 to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations []

Secondary Outcome Measures

1. To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations []

2. To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients []

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Post-menopausal women between 45 and 79 years of age

• Must be osteopenic/osteoporotic

• Treatment with oral bisphosphonate for at least 1 year

Exclusion Criteria:

• Any woman of child bearing potential

• Treatment with other bone active agents

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Permanente Medical Group	Santa Rosa	California	United States	95403
2	Colorado Center for Bone Research	Lakewood	Colorado	United States	80227
3	Florida Medical Research Institute	Gainsville	Florida	United States	32605
4	Radiant Research	Stuart	Florida	United States	34996
5	University of Kansas School of Medicine/ Division of Endocrinology	Kansas City	Kansas	United States	66160
6	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
7	Arthritis Center of Nebraska	Lincoln	Nebraska	United States	68516
8	Creighton University Osteoporosis Research Center	Omaha	Nebraska	United States	68131
9	Oregon Osteoporosis Center	Portland	Oregon	United States	97213
10	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
11	Radiant Research	Wyomissing	Pennsylvania	United States	19610
12	Puget Sound Osteoporosis Center	Seattle	Washington	United States	98144
13	Novartis	Nuernberg		Germany

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00097812
• Other Study ID Numbers: CZOL446H2313
• First Posted: Dec 1, 2004
• Last Update Posted: Apr 27, 2012
• Last Verified: Apr 1, 2012

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

Study Results

No Results Posted as of Apr 27, 2012