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

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Novartis

Status and phase

Completed
Phase 3

Conditions

Osteopenia

Treatments

Drug: zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00145275
CZOL446H2407

Details and patient eligibility

About

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.

Sex

Female

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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