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Completed

NCT Number: NCT02561039

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

This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 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

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Burgas, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults at least 18 years of age
  • Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
  • Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
  • Radiologically confirmed bone disease disease

Exclusion criteria

  • Previous treatment with ibandronate (Bondronat) within previous 2 months
  • Severely impaired renal function
  • Known brain metastases

Treatment and study plan

Ibandronate

Drug

Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.

Other names: Bondronat

Primary outcomes

  1. Response rate according to reduction in BPI most acute pain score from Baseline

    Time frame: Month 4

  2. Change in KPI

    Time frame: Baseline to Month 4

Secondary outcomes

  1. Time to onset of decrease in most acute pain score

    Time frame: Up to 4 months

  2. Analgesic consumption according to participant diary

    Time frame: Up to 5 months

  3. Incidence of adverse events

    Time frame: Up to 5 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 25, 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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