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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564107

Enrollment

Registered

2015-09-30

Start date

2004-11-30

Completion date

2006-04-30

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 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.

Interventions

DRUGIbandronate

Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)	Up to 25 weeks

Secondary

Measure	Time frame
Incidence of bone pain according to participant questionnaire	Up to 25 weeks
Analgesic consumption according to participant questionnaire	Up to 25 weeks
Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)	Up to 25 weeks
Short Form 36 (SF-36) score	Up to 25 weeks
Incidence of adverse events (AEs)	Up to approximately 7 months

Countries

Bulgaria

Outcome results

None listed

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