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Completed

NCT Number: NCT02564107

A Study of Ibandronate (Bondronat) in Participants With 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.

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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 4

Primary location

Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ibandronate

Drug

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

Other names: Bondronat

Primary outcomes

  1. Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)

    Time frame: Up to 25 weeks

Secondary outcomes

  1. Incidence of bone pain according to participant questionnaire

    Time frame: Up to 25 weeks

  2. Analgesic consumption according to participant questionnaire

    Time frame: Up to 25 weeks

  3. Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)

    Time frame: Up to 25 weeks

  4. Short Form 36 (SF-36) score

    Time frame: Up to 25 weeks

  5. Incidence of adverse events (AEs)

    Time frame: Up to approximately 7 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 30, 2015
Registry last updated
Nov 2, 2016

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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