NCT06059222

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Oct 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

September 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

October 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

September 8, 2023

Last Update Submit

October 23, 2023

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change in total hip BMD

    Change in total hip BMD

    24 months

Secondary Outcomes (3)

  • Changes in femoral neck BMD

    24 months

  • Changes in trabecular bone volume fraction (bone volume/tissue volume, BV/TV) and cortical porosity measured by high-resolution peripheral quantitative computed tomography (HR-pQCT)

    24 months

  • Change in spine BMD

    24 months

Other Outcomes (9)

  • Bone resorption and formation -Changes in P1NP (procollagen type I N-terminal propeptide)

    1, 3, 6, 12, 18, 19, 21 and 24 months

  • Bone resorption and formation - Changes in CTX

    1, 3, 6, 12, 18, 19, 21 and 24 months

  • Bone resorption and formation - Changes in collagen

    1, 3, 6, 12, 18, 19, 21 and 24 months

  • +6 more other outcomes

Study Arms (3)

Group 1 - ROMO 12 months, ZOL 12 months

ACTIVE COMPARATOR

90 patients 12 months of romosozumab (ROMO) followed by 12 months of zoledronate (ZOL)

Drug: RomosozumabDrug: Zoledronate

Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 months

ACTIVE COMPARATOR

90 patients 6 months of romosozumab followed by 12 months of zoledronate and lastly 6 months of romosozumab.

Drug: RomosozumabDrug: Zoledronate

Group 3 - ROMO 6 months, ZOL 18 months

ACTIVE COMPARATOR

90 patients 6 months of romosozumab followed by 18 months of zoledronate .

Drug: RomosozumabDrug: Zoledronate

Interventions

RomosozumabDRUG

Romosozumab 210 mg/2.34 ml from baseline to month 11

Also known as: Evenity
Group 1 - ROMO 12 months, ZOL 12 months
ZoledronateDRUG

5 mg/100 ml at month 12

Group 1 - ROMO 12 months, ZOL 12 months

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (postmenopausal for at least two years)
  • BMD T-score \< -2.5 at lumbar spine, total hip, or femoral neck
  • Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.

You may not qualify if:

  • Osteoporosis treatment including hormone replacement therapy within the last 5 years
  • Metabolic bone disease
  • Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease
  • Ongoing treatment with glucocorticoids (systemic)
  • Estimated glomerular filtration rate (eGFR) \< 35 mL/min
  • Contraindications for zoledronate according to the Supplementary protection certificates (SPC)
  • Contraindications for romosozumab according to the SPC
  • For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC
  • For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endrocinology and Internal Medicine

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

romosozumabZoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bente Langdahl, MD, Professor, DMSc, PhD,

    Department of Endocrinology and Internal medicin, Aarhus University Hospital

    STUDY DIRECTOR

Central Study Contacts

Vivi Makinen, MD

CONTACT

78450000vivmaa@rm.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 28, 2023

Study Start

October 2, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

October 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)