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OpenTrials
Completed

NCT Number: NCT00502736

A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

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Key information

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ankara, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients, >=18 years of age;
  • breast cancer;
  • bone metastases;
  • moderate to severe pain;
  • adequate renal function.

Exclusion criteria

  • bisphosphonate treatment within 3 weeks of study enrollment.

Treatment and study plan

ibandronate [Bondronat]

Drug

6mg iv on days 1-3

Primary outcomes

  1. Pain and analgesic consumption

    Time frame: Days 1, 7 and 14

Secondary outcomes

  1. AEs and laboratory parameters

    Time frame: Days 1, 4 and 7

  2. Serum creatinine

    Time frame: Days 1, 4 and 7

  3. Karnofsky index

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 18, 2007
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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