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

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