NCT06059222 (OPTIMIST) is a Phase 4 clinical trial of Romosozumab in Osteoporosis, sponsored by University of Aarhus.

Who is sponsoring NCT06059222?

NCT06059222 is sponsored by University of Aarhus.

What drugs are being tested in NCT06059222?

Interventions in NCT06059222: Romosozumab, Zoledronate, Romosozumab, Zoledronate, Romosozumab, Zoledronate.

What condition does NCT06059222 study?

NCT06059222 studies Osteoporosis.

Is NCT06059222 still recruiting?

NCT06059222 is currently recruiting now. Last updated 23 October 2023.

Last reviewed 2023-10-23 · How we verify

NCT06059222: OPTIMIST

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

The Optimised Use of Romozosumab Study

Recruiting now Phase 4 Last updated 23 October 2023

What this trial tests

Phase 4 trial testing Romosozumab in Osteoporosis in 270 participants. Currently enrolling.

Timeline

2 October 2023

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	270
Start date	2 October 2023
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across Denmark

Drugs / interventions tested

Romosozumab (romosozumab) — full drug profile →
Zoledronate — full drug profile →
Romosozumab (romosozumab) — full drug profile →
Zoledronate — full drug profile →
Romosozumab (romosozumab) — full drug profile →
Zoledronate — full drug profile →

Conditions studied

Osteoporosis — all drugs for Osteoporosis →

Sponsor

University of Aarhus

Who can join

50 and older, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in total hip BMD
Time frame: 24 months
Change in total hip BMD

Sponsor's own description

OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively). The study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Bone-derived factors mediate crosstalk between skeletal and extra-skeletal organs.
He T, Qin L, Chen S, Huo S, et al · · 2025 · cited 20× · PMID 40307216 · DOI 10.1038/s41413-025-00424-1

Verify or expand the search:

Other trials of Romosozumab

Trials testing the same drug.

NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
NCT07384104 — Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in He · Phase 1 · enrolling by invitation
NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
NCT05972551 — Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Oste · Phase 3 · recruiting
NCT06079476 — A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. · Phase 4 · completed

Other recruiting trials for Osteoporosis

Currently open trials in the same condition.

NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting

Other University of Aarhus trials

Trials by the same sponsor.

NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · 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 NCT06059222 (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 of Aarhus
Last refreshed: 23 October 2023

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/NCT06059222.

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