NCT02286830

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_4 multiple-myeloma

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

8.1 years

First QC Date

March 12, 2014

Last Update Submit

February 16, 2023

Conditions

Multiple Myeloma

Keywords

osteolysiszoledronic acidosteonecrosisbone markerslow-dose CT

Outcome Measures

Primary Outcomes (1)

  • time to first skeletal related event after randomisations at year two

    After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.

    From year two to year four

Secondary Outcomes (1)

  • Value of serum bone marker ratio (bone resorption / bone formation markers) as predictor of skeletal related related events analysed by time-dependent multiparameter Cox regression analysis.

    4 years

Other Outcomes (4)

  • Number of lesions identified with conventional radiography and low-dose CT

    4 years

  • register incidence of osteonecrosis of the jaw

    4 years

  • register creatinine levels in serum

    4 years

  • +1 more other outcomes

Study Arms (2)

zoledronic acid

ACTIVE COMPARATOR

treatment with zoledronic acid for 4 years

Drug: Zoledronic acid

no treatment

PLACEBO COMPARATOR

treatment with zoledronic acid withheld after two years

Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG

Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment.

Also known as: Zometa
no treatmentzoledronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Multiple MyelomaOsteolysisOsteonecrosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas LunD, MD Ph.D.

    Department of hematology, Odense University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD Ph.D.

Study Record Dates

First Submitted

March 12, 2014

First Posted

November 10, 2014

Study Start

January 1, 2015

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

DK(1)