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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145275
First Posted: September 5, 2005
Last Update Posted: April 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00145275     History of Changes
Other Study ID Numbers: CZOL446H2407
First Submitted: September 1, 2005
First Posted: September 5, 2005
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Novartis:
zoledronic acid
bisphosphonate
Low bone mass

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Analgesics
Zoledronic acid
Diphosphonates
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bone Density Conservation Agents