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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00145275
First received: September 1, 2005
Last updated: April 26, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00145275     History of Changes
Other Study ID Numbers: CZOL446H2407
Study First Received: September 1, 2005
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
zoledronic acid
bisphosphonate
Low bone mass

Additional relevant MeSH terms:
Analgesics
Zoledronic acid
Bone Density Conservation Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014