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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00100555

Enrollment

120

Registered

2005-01-04

Start date

2004-06-30

Completion date

2005-06-30

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

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

* 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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—
To assess the frequency, intensity, and bothersomeness of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist	—
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy	—

Countries

United States

Outcome results

None listed

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