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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4004
      • Shumen, Bulgaria
      • Sofia, Bulgaria, 1756
      • Sofia, Bulgaria, 1784
      • Sofia, Bulgaria, 1527
      • Stara Zagora, Bulgaria, 8000
      • Varna, Bulgaria, 9010
      • Veliko Tarnovo, Bulgaria, 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate
Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
Drug: Ibandronate
Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.
Other Names:
  • Bondronat

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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