Clinical trial · Interventional
4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases
A Pragmatic Randomised, Multicentre Trial Comparing 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases From Either Castration-resistant Prostate Cancer or Breast Cancer - The REaCT-BTA Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Drug | Denosumab | ALIAS |
| Pamidronate | Drug | — | UNRESOLVED |
| Zoledronate | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 4 weekly bone-targeted agent x 1 year
- description
- Bone targeting agents as standard of care
- interventionNames
- Drug: Pamidronate
- Drug: Denosumab
- Drug: Zoledronate
- type
- ACTIVE_COMPARATOR
- label
- 12 weekly bone-targeted agent x 1 year
- description
- Bone targeting agents as standard of care
- interventionNames
- Drug: Pamidronate
- Drug: Denosumab
- Drug: Zoledronate
Primary outcomes (1)
- measure
- Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTu 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