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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02561039
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain; Bone Neoplasms; Neoplasm Metastasis Drug: Ibandronate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

Arm Intervention/treatment
Experimental: Ibandronate IV Infusion
Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
Drug: Ibandronate
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 Name: Bondronat

Experimental: Ibandronate PO Tablet
Participants will receive ibandronate, 50 mg PO daily, for 4 months.
Drug: Ibandronate
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 Name: Bondronat




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561039


Locations
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Bulgaria
Bourgas, Bulgaria, 8000
Haskovo, Bulgaria, 6300
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1757
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9002
Varna, Bulgaria, 9010
Vratza, Bulgaria, 3000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02561039    
Other Study ID Numbers: ML20713
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Neoplasms by Site
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs