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

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ClinicalTrials.gov Identifier: NCT02564107
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain; Bone Neoplasms; Neoplasm Metastasis Drug: Ibandronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
Study Start Date : November 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

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 Name: Bondronat




Primary Outcome Measures :
  1. Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR) [ Time Frame: Up to 25 weeks ]

Secondary Outcome Measures :
  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 ]


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

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

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): NCT02564107


Locations
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Bulgaria
Plovdiv, Bulgaria, 4004
Shumen, Bulgaria
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1784
Stara Zagora, Bulgaria, 8000
Varna, Bulgaria, 9010
Veliko Tarnovo, Bulgaria, 5000
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: NCT02564107     History of Changes
Other Study ID Numbers: ML18044
First Posted: September 30, 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