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

NCT02721433 | Completed Phase 4

• 1 other identifier: 16-01
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Prostate Cancer; Metastasis

Outcome Measures

Primary Outcomes (1)

• Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain)

  Units on a scale

  1 year

Secondary Outcomes (7)

• Pain will be measured through the EORTC-Quality of Life Questionnaire (QLQ)-BM22 (pain domain)

  1 year

• Health related quality of life scores

  1 year

• Time to development of symptomatic skeletal events (SSEs)

  2 year

• Total number of and time to subsequent on study SSE - to calculate Skeletal Morbidity Rates

  2 year

• For sites where Edmonton Symptom Assessment Scores (ESAS) are performed as standard of care, the ESAS scores will also be collected.

  2 year

Study Arms (2)

4 weekly bone-targeted agent x 1 year

ACTIVE COMPARATOR

Bone targeting agents as standard of care

Drug: Pamidronate; Drug: Denosumab; Drug: Zoledronate

12 weekly bone-targeted agent x 1 year

ACTIVE COMPARATOR

Bone targeting agents as standard of care

Drug: Pamidronate; Drug: Denosumab; Drug: Zoledronate

Interventions

Pamidronate DRUG

Bone-targeted agent as standard of care

Also known as: Aredia

12 weekly bone-targeted agent x 1 year; 4 weekly bone-targeted agent x 1 year

Denosumab DRUG

Bone-targeted agent as standard of care

Also known as: Prolia

12 weekly bone-targeted agent x 1 year; 4 weekly bone-targeted agent x 1 year

Zoledronate DRUG

Bone-targeted agent as standard of care

Also known as: Zometa

12 weekly bone-targeted agent x 1 year; 4 weekly bone-targeted agent x 1 year

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 34068083 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Pamidronate; Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Clemons, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 29, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: April 1, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)