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4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

NCT ID: NCT02721433

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-04-30

Brief Summary

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The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Detailed Description

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Bone metastases are common in patients with advanced breast and prostate cancers. Skeletal metastases can be associated with reduced Quality of Life (QoL), pain and skeletal-related events (SREs) (defined as pathological fractures, surgery/radiotherapy to bone, spinal cord compression and hypercalcaemia). Maintaining QoL while avoiding or delaying SREs are the main goals of therapy. Patients therefore receive bone-targeted agents (e.g. pamidronate, zoledronate and denosumab) which are typically given every 4 weeks. However, this 4 week dosing is based on convenience so the treatment could be given concurrently with chemotherapy. The half-life of these drugs in the bone is many months or even years. Hence studies have been performed evaluating 12-weekly therapy. These have confirmed similar palliative outcomes in the 4 vs 12-weekly groups for both breast and prostate cancer patients. However, there remains clinical equipoise about which dosing interval physicians prescribe. The current trial will compare these two schedules of bone-targeting agents (12- vs. 4-weekly) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Conditions

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Breast Cancer Prostate Cancer Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 weekly bone-targeted agent x 1 year

Bone targeting agents as standard of care

Group Type ACTIVE_COMPARATOR

Pamidronate

Intervention Type DRUG

Bone-targeted agent as standard of care

Denosumab

Intervention Type DRUG

Bone-targeted agent as standard of care

Zoledronate

Intervention Type DRUG

Bone-targeted agent as standard of care

12 weekly bone-targeted agent x 1 year

Bone targeting agents as standard of care

Group Type ACTIVE_COMPARATOR

Pamidronate

Intervention Type DRUG

Bone-targeted agent as standard of care

Denosumab

Intervention Type DRUG

Bone-targeted agent as standard of care

Zoledronate

Intervention Type DRUG

Bone-targeted agent as standard of care

Interventions

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Pamidronate

Bone-targeted agent as standard of care

Intervention Type DRUG

Denosumab

Bone-targeted agent as standard of care

Intervention Type DRUG

Zoledronate

Bone-targeted agent as standard of care

Intervention Type DRUG

Other Intervention Names

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Aredia Prolia Zometa

Eligibility Criteria

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Inclusion Criteria

* Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.
* About to start or currently receiving BTA therapy.
* Serum creatinine \>30 ml/min and corrected serum calcium ≥ 2 mmol/l
* Age ≥ 18 years.
* Able to provide verbal consent

Exclusion Criteria

* For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia \[Albumin-corrected serum calcium \< 2.0 mmol/l\]).
* History of or current evidence of osteonecrosis of the jaw.
* Radiotherapy or surgery to the bone planned within 4 weeks after randomization.
* Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose).
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Clemons, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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Tu MM, Clemons M, Stober C, Jeong A, Vandermeer L, Mates M, Blanchette P, Joy AA, Aseyev O, Pond G, Fergusson D, Ng TL, Thavorn K. Cost-Effectiveness Analysis of 12-Versus 4-Weekly Administration of Bone-Targeted Agents in Patients with Bone Metastases from Breast and Castration-Resistant Prostate Cancer. Curr Oncol. 2021 May 13;28(3):1847-1856. doi: 10.3390/curroncol28030171.

Reference Type DERIVED
PMID: 34068083 (View on PubMed)

Other Identifiers

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16-01

Identifier Type: -

Identifier Source: org_study_id