To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145275

Enrollment

455

Registered

2005-09-05

Start date

2004-12-31

Completion date

2005-10-31

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

Osteopenia

Keywords

zoledronic acid, bisphosphonate, Low bone mass

Brief summary

Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.

Interventions

DRUGzoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Inclusion criteria

* Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive * Low bone mineral density

Exclusion criteria

* Certain prior treatments for low bone mass/osteopenia * Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation * Impaired kidney function Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Temperature increase	—

Secondary

Measure	Time frame
Questionnaires	—
VAS (visual analog scale)	—

Countries

Australia, Canada, Russia, South Africa, United States

Outcome results

None listed

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