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

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00145275

Purpose

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.

Condition	Intervention	Phase
Osteopenia	Drug: zoledronic acid	Phase III

MedlinePlus related topics: Fever Menopause Over-the-Counter Medicines

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Temperature increase

Secondary Outcome Measures:

Questionnaires
VAS (visual analog scale)

Estimated Enrollment:	455
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Female

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145275

Locations

United States, Georgia

Unavailable, Georgia, United States
United States, Illinois

Unavailable, Illinois, United States
United States, Indiana

Unavailable, Indiana, United States
United States, Iowa

Unavailable, Iowa, United States
United States, Kansas

Unavailable, Kansas, United States
United States, Washington

Unavailable, Washington, United States
Australia

Multiple, Australia
Canada

Multiple, Canada
Russian Federation

Multiple, Russian Federation
South Africa

Multiple, South Africa

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CZOL446H2407
Study First Received:	September 1, 2005
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00145275
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

zoledronic acid
bisphosphonate
Low bone mass

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases

Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009