A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02561039

Enrollment

Registered

2015-09-25

Start date

2006-12-31

Completion date

2008-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

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.

Interventions

DRUGIbandronate

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Response rate according to reduction in BPI most acute pain score from Baseline	Month 4
Change in KPI	Baseline to Month 4

Secondary

Measure	Time frame
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

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026