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

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.

Completed

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Multiple, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

Temperature increase

Secondary outcomes

Questionnaires
VAS (visual analog scale)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 5, 2005
Registry last updated: Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed