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

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561039
• Other study ID #: ML20713
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2015
• Last updated: November 1, 2016
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Bone Neoplasms
• Neoplasm Metastasis
• Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention

Drug:
• Ibandronate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to reduction in BPI most acute pain score from Baseline		Month 4	No
Primary	Change in KPI		Baseline to Month 4	No
Secondary	Time to onset of decrease in most acute pain score		Up to 4 months	No
Secondary	Analgesic consumption according to participant diary		Up to 5 months	No
Secondary	Incidence of adverse events		Up to 5 months	No