Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097812

Enrollment

220

Registered

2004-12-01

Start date

2004-05-31

Completion date

2005-12-31

Last updated

2012-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, osteopenia, post-menopausal, zoledronic acid

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.

Interventions

DRUGzoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 79 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations	—
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients	—
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026