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

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title:

An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564107
• Other study ID #: ML18044
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2015
• Last updated: November 1, 2016
• Start date: November 2004
• Est. completion date: April 2006

Study information

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

Clinical Trial Summary

This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females at least 18 years of age

• Breast cancer

• Bone metastases

Exclusion Criteria:

• Use of bisphosphonates within the last 3 months

• Prior use of gallium nitrate or metastron

• Severely impaired renal function

• Hypocalcemia or primary hyperparathyroidism

• Central nervous system (CNS) metastases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.

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	Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)		Up to 25 weeks	No
Secondary	Incidence of bone pain according to participant questionnaire		Up to 25 weeks	No
Secondary	Analgesic consumption according to participant questionnaire		Up to 25 weeks	No
Secondary	Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)		Up to 25 weeks	No
Secondary	Short Form 36 (SF-36) score		Up to 25 weeks	No
Secondary	Incidence of adverse events (AEs)		Up to approximately 7 months	No