CompletedPhase 4

Prolonged Protection From Bone Disease in Multiple Myeloma

Denmark158 participantsStarted 2015-01

Plain-language summary

Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until progression in bone disease compared to patients who stop treatment after two years? Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease in the individual patient? Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in Multiple Myeloma compared to conventional radiography

Who can participate

Age range18 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: * Symptomatic Multiple Myeloma regardless of bone disease status * Signed Informed Consent * Age ≥ 18 years * Remaining life expectancy ≥ 2 years * Any concurrently anti-myeloma treatment are allowed Exclusion Criteria: * Previous treatment with bisphosphonate within the last 6 months * Severely reduced renal function (creatinine clearance \<30 mL/min despite fluid replacement) * Known concurrent malignancy, excluding skin cancer * Known hypersensitivity to zoledronic acid * Pregnant or lactating women * Women of childbearing potential or men engaging in sexual activity with a woman of childbearing potential who refuse to use contraception

What they're measuring

time to first skeletal related event after randomisations at year two

Timeframe: From year two to year four

Trial details

NCT IDNCT02286830

SponsorThomas Lund

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-16

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