NCT03336983 (BonEnza) is a Phase 2 clinical trial of Zoledronic Acid in Prostate Cancer, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.

Who is sponsoring NCT03336983?

NCT03336983 is sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.

What drugs are being tested in NCT03336983?

Interventions in NCT03336983: Zoledronic Acid, Enzalutamide.

What condition does NCT03336983 study?

NCT03336983 studies Prostate Cancer, Bone Metastases.

Is NCT03336983 still recruiting?

NCT03336983 is currently completed. Last updated 1 August 2024.

Last reviewed 2024-08-01 · How we verify

NCT03336983: BonEnza

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

Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients

Completed Phase 2 Last updated 1 August 2024

What this trial tests

Phase 2 trial testing Zoledronic Acid in Prostate Cancer in 126 participants. Completed in 1 April 2023.

Timeline

1 December 2017

Primary endpoint
30 June 2022

1 April 2023

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	1 December 2017
Primary completion	30 June 2022
Estimated completion	1 April 2023
Sites	1 location across Italy

Drugs / interventions tested

Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →
Enzalutamide (enzalutamide) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Bone Metastases — all drugs for Bone Metastases →

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Bone Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was undertaken to evaluate bone response in metastatic prostate cancer patients treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing hormone-releasing hormone (LHRH) analogue with the use of Whole Boby (WB) DW-MRI.

Publications & conference data

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

Macrophages as a Therapeutic Target in Metastatic Prostate Cancer: A Way to Overcome Immunotherapy Resistance?
Martori C, Sanchez-Moral L, Paul T, Pardo JC, et al · · 2022 · cited 43× · PMID 35053602 · DOI 10.3390/cancers14020440
Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis.
Jakob T, Tesfamariam YM, Macherey S, Kuhr K, et al · · 2020 · cited 31× · PMID 33270906 · DOI 10.1002/14651858.cd013020.pub2
Case Report: 18F-PSMA PET/CT Scan in Castration Resistant Prostate Cancer With Aggressive Neuroendocrine Differentiation.
Bergamini M, Dalla Volta A, Caramella I, Bercich L, et al · · 2022 · cited 6× · PMID 35936689 · DOI 10.3389/fonc.2022.937713
Total and Regional Changes in Body Composition in Metastatic Hormone-sensitive Prostate Cancer Patients Randomized to Receive Androgen Deprivation + Enzalutamide ± Zoledronic Acid. The BONENZA Study.
Buffoni M, Dalla Volta A, Valcamonico F, Bergamini M, et al · · 2025 · cited 2× · PMID 40300921 · DOI 10.1016/j.euo.2025.02.006

Verify or expand the search:

Other trials of Zoledronic Acid

Trials testing the same drug.

NCT05666310 — Muscle Impact of Treating Osteoporosis · Phase 4 · active not recruiting
NCT04597931 — Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density · Phase 4 · unknown
NCT04736693 — Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data · completed
NCT04087096 — Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery · Phase 4 · completed
NCT04303026 — The Effect of Zoledronic Acid on Patients With Osteoarthritis of the Hip · Phase 3 · unknown

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia trials

Trials by the same sponsor.

NCT06493708 — Effectiveness of EMDR in Borderline Personality Disorder · NA · recruiting
NCT07370961 — Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment · NA · completed
NCT05847387 — The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study · recruiting
NCT05738902 — Adherence and Compliance to ERAS in Gynecological Surgery · unknown
NCT06765343 — Efficacy of Guided Biofilm Therapy in Pediatric Patient · NA · completed

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 NCT03336983 (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 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Last refreshed: 1 August 2024

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/NCT03336983.

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