NCT03520231 is a Phase 2 clinical trial of Denosumab in Urothelial Carcinoma, sponsored by University Health Network, Toronto.

Who is sponsoring NCT03520231?

NCT03520231 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT03520231?

Interventions in NCT03520231: Denosumab, Denosumab Placebo, Gemcitabine, Carboplatin, Cisplatin, Calcium, Vitamin D.

What condition does NCT03520231 study?

NCT03520231 studies Urothelial Carcinoma, Kidney Cancer, Ureter Cancer, Bladder Cancer.

Is NCT03520231 still recruiting?

NCT03520231 is currently completed. Last updated 23 November 2021.

Last reviewed 2021-11-23 · How we verify

NCT03520231

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases

Completed Phase 2 Last updated 23 November 2021

What this trial tests

Phase 2 trial testing Denosumab in Urothelial Carcinoma in 6 participants. Completed in 1 December 2020.

Timeline

4 September 2018

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	4 September 2018
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across Canada

Drugs / interventions tested

Denosumab
Denosumab Placebo — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Calcium (CALCIUM) — full drug profile →
Vitamin D

Conditions studied

Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
Kidney Cancer — all drugs for Kidney Cancer →
Ureter Cancer — all drugs for Ureter Cancer →
Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Urothelial Carcinoma or Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 2 study of the drug denosumab for the management bone metastases from urothelial cancer. The purpose of this study is to find out how effective denosumab is in the management of bone metastases from urothelial cancer. This will be done by comparing denosumab with standard treatment, compared to placebo and standard treatment. Denosumab is a monoclonal antibody that binds to a protein called Receptor Activator of Nuclear Factor κB (RANK). RANK works by telling certain cells called osteoclasts to break down bone tissue. The binding of denosumab to RANK stops it from telling osteoclasts to break down bone tissue which may help with symptoms related bone metastases from urothelial cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

NF-κB signaling in inflammation and cancer.
Zhang T, Ma C, Zhang Z, Zhang H, et al · · 2021 · cited 386× · PMID 34977871 · DOI 10.1002/mco2.104
Bone metastases from urothelial carcinoma. The dark side of the moon.
Stellato M, Santini D, Cursano MC, Foderaro S, et al · · 2021 · cited 17× · PMID 34934613 · DOI 10.1016/j.jbo.2021.100405
The prognostic impact of bone metastasis in patients with metastatic urothelial carcinoma treated with first-line platinum-based chemotherapy.
Alqaisi HA, Stecca C, Veitch ZW, Riromar J, et al · · 2022 · cited 8× · PMID 35520101 · DOI 10.1177/17588359221094879
Poster Session 9: Oncology–Kidney, Testes, Penile : Sunday, June 29, 2025 • 07:00–08:30
Bahadori A, Bray G, Chung D, Haramesiw O, et al · · 2025

Verify or expand the search:

Other trials of Denosumab

Trials testing the same drug.

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NCT06524960 — Denosumab for Type 1 Diabetes · Phase 1, PHASE2 · recruiting

Other recruiting trials for Urothelial Carcinoma

Currently open trials in the same condition.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07421700 — Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer · Phase 1, PHASE2 · recruiting
NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting

Other University Health Network, Toronto trials

Trials by the same sponsor.

NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03520231 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
Last refreshed: 23 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03520231.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing