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The Optimised Use of Romozosumab Study

NCT06059222 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-10-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Romosozumab

Romosozumab 210 mg/2.34 ml from baseline to month 11

DRUG

Zoledronate

5 mg/100 ml at month 12

DRUG

Romosozumab

210 mg/2.34 ml from baseline to month 5 and from month 18 to month 23

DRUG

Zoledronate

5 mg/100 ml at month 6

DRUG

Romosozumab

210 mg/2.34 ml from baseline to month 5

DRUG

Zoledronate

5 mg/100 ml at month 5 and month 18

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Bente Langdahl, MD, Professor, DMSc, PhD, · Department of Endocrinology and Internal medicin, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059222 on ClinicalTrials.gov