NCT05655013 is a Phase 4 clinical trial of Zoledronate in Osteoporosis, Postmenopausal, sponsored by Aarhus University Hospital.

Who is sponsoring NCT05655013?

NCT05655013 is sponsored by Aarhus University Hospital.

What drugs are being tested in NCT05655013?

Interventions in NCT05655013: Zoledronate, Placebo.

What condition does NCT05655013 study?

NCT05655013 studies Osteoporosis, Postmenopausal.

Is NCT05655013 still recruiting?

NCT05655013 is currently active, enrolled. Last updated 2 October 2025.

Last reviewed 2025-10-02 · How we verify

NCT05655013

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

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

Active, enrolled Phase 4 Last updated 2 October 2025

What this trial tests

Phase 4 trial testing Zoledronate in Osteoporosis, Postmenopausal in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2023

Primary endpoint
1 February 2027

1 February 2027

Quick facts

Lead sponsor	Aarhus University Hospital
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	10 May 2023
Primary completion	1 February 2027
Estimated completion	1 February 2027
Sites	1 location across Denmark

Drugs / interventions tested

Zoledronate — full drug profile →
Placebo

Conditions studied

Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →

Sponsor

Aarhus University Hospital

Who can join

Adults 40 to 100, female only, with Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Zoledronate

Trials testing the same drug.

NCT05598606 — Denosumab vs Zoledronate After Vertebroplasty · Phase 4 · completed
NCT05638399 — Denosumab vs Zoledronate After Lumbar Fusion · Phase 3 · unknown
NCT03664687 — Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL) · Phase 4 · completed
NCT03358017 — Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer · Phase 2 · completed
NCT02347163 — Pre-operative Zoledronate in Triple Negative Breast Cancer · Phase 2 · terminated

Other recruiting trials for Osteoporosis, Postmenopausal

Currently open trials in the same condition.

NCT07242612 — Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis · NA · recruiting
NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
NCT06655701 — Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis · recruiting
NCT06525688 — New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies · recruiting
NCT05853354 — Comparative Efficacy, Safety, PK, and Immunogenicity Study · Phase 3 · active not recruiting

Other Aarhus University Hospital trials

Trials by the same sponsor.

NCT07432802 — Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer · NA · not yet recruiting
NCT07499336 — UNDERSTANDING THE T-CELL AND B-CELL RECEPTOR REPERTOIRE IN CHILDREN AND YOUNG ADULTS WITH ANTI-DRUG ANTIBODIES AGAINST P · not yet recruiting
NCT07454486 — TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cance · not yet recruiting
NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
NCT07426250 — Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease · 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 NCT05655013 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aarhus University Hospital
Last refreshed: 2 October 2025

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/NCT05655013.

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