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

Completed · Phase 3

Conditions studied: Osteopenia

In brief

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.

Key facts

Study ID

NCT00145275

Run by

Novartis

People needed

455

Starts

2004-12-01

Expected to finish

2005-10-01

Last updated by the study team

2012-04-27

Who can join

Age: 45 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Unavailable, Georgia, United States
• Study site — Unavailable, Illinois, United States
• Study site — Unavailable, Indiana, United States
• Study site — Unavailable, Iowa, United States
• Study site — Unavailable, Kansas, United States
• Study site — Unavailable, Washington, United States
• Study site — Multiple, Australia
• Study site — Multiple, Canada
• Study site — Multiple, Russia
• Study site — Multiple, South Africa

Full record on ClinicalTrials.gov

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