CompletedPhase 1

Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year

United States18 participantsStarted 2006-11

Plain-language summary

The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female between 18-75 years of age * Multiple myeloma or breast cancer with bone involvement * Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received. Exclusion Criteria: * Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery * Active or uncontrolled infection, liver, or renal disease * History of treatment with intravenous bisphosphonates * Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease) Other protocol-defined inclusion/exclusion criteria may apply.

What they're measuring

Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17

Timeframe: every four (4) weeks

Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13

Timeframe: every four (4) weeks

Trial details

NCT IDNCT00424983

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

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