Radium-223 Dichloride Long-term Follow-up Program
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02312960 |
Recruitment Status :
Recruiting
First Posted : December 9, 2014
Last Update Posted : February 18, 2021
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Condition or disease | Intervention/treatment | Phase |
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Neoplasm Metastasis / Bone and Bones | Other: Data Collection | Phase 4 |
This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).
The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 800 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride |
Actual Study Start Date : | December 18, 2014 |
Estimated Primary Completion Date : | October 30, 2023 |
Estimated Study Completion Date : | October 30, 2023 |

Arm | Intervention/treatment |
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Arm 1
The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.
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Other: Data Collection
No study treatment will be provided in this long term follow up study. |
- Incidence of radium-223 dichloride related Adverse Events [ Time Frame: Up to 7 years ]
- Severity of radium-223 dichloride related Adverse Events [ Time Frame: Up to 7 years ]Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)
- Incidence of radium-223 dichloride related Serious Adverse Events [ Time Frame: Up to 7 years ]
- Incidence of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
- Severity of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
- Incidence of placebo-related Serious Adverse Events [ Time Frame: Up to 7 years ]
- Incidence of leukemia [ Time Frame: Up to 7 years ]
- Incidence of myelodysplastic syndrome [ Time Frame: Up to 7 years ]
- Incidence of aplastic anemia [ Time Frame: Up to 7 years ]
- Incidence of primary bone cancer [ Time Frame: Up to 7 years ]
- Incidence of any other new primary malignancy [ Time Frame: Up to 7 years ]
- Incidence of bone fractures [ Time Frame: Up to 7 years ]
- Incidence of bone-associated events [ Time Frame: Up to 7 years ]
- Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
- Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
Exclusion Criteria:
- Not applicable to this follow up study

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): NCT02312960
Contact: Bayer Clinical Trials Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |

Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02312960 |
Other Study ID Numbers: |
16996 2014-002407-25 ( EudraCT Number ) |
First Posted: | December 9, 2014 Key Record Dates |
Last Update Posted: | February 18, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |