NCT02561039

Brief Summary

This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

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

Study Start

First participant enrolled

December 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

September 24, 2015

Last Update Submit

November 1, 2016

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (2)

  • Response rate according to reduction in BPI most acute pain score from Baseline

    Month 4

  • Change in KPI

    Baseline to Month 4

Secondary Outcomes (3)

  • Time to onset of decrease in most acute pain score

    Up to 4 months

  • Analgesic consumption according to participant diary

    Up to 5 months

  • Incidence of adverse events

    Up to 5 months

Study Arms (2)

Ibandronate IV Infusion

EXPERIMENTAL

Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.

Drug: Ibandronate

Ibandronate PO Tablet

EXPERIMENTAL

Participants will receive ibandronate, 50 mg PO daily, for 4 months.

Drug: Ibandronate

Interventions

IbandronateDRUG

Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.

Also known as: Bondronat
Ibandronate IV InfusionIbandronate PO Tablet

Eligibility Criteria

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

You may qualify if:

  • Adults at least 18 years of age
  • Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
  • Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
  • Radiologically confirmed bone disease disease

You may not qualify if:

  • Previous treatment with ibandronate (Bondronat) within previous 2 months
  • Severely impaired renal function
  • Known brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Burgas, 8000, Bulgaria

Location

Unknown Facility

Haskovo, 6300, Bulgaria

Location

Unknown Facility

Pleven, 5800, Bulgaria

Location

Unknown Facility

Plovdiv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1757, Bulgaria

Location

Unknown Facility

Sofia, 1784, Bulgaria

Location

Unknown Facility

Varna, 9002, Bulgaria

Location

Unknown Facility

Varna, 9010, Bulgaria

Location

Unknown Facility

Vratsa, 3000, Bulgaria

Location

MeSH Terms

Conditions

PainBone NeoplasmsNeoplasm Metastasis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesNeoplastic ProcessesPathologic Processes

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 25, 2015

Study Start

December 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

BU(9)