The Optimised Use of Romozosumab Study

Phase 4

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: Romosozumab; Drug: Zoledronate

• Registration Number: NCT06059222
• Lead Sponsor: University of Aarhus

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).
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Detailed Description

Recent clinical trials have demonstrated the benefit of bone anabolic treatment over no treatment or antiresorptive treatment in terms of increasing bone mineral density (BMD) and reducing fracture risk for patients with osteoporosis. However, the bone anabolic treatment is expensive and therefore restricted to a limited group of patients.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Study Start: 2023-10-02
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - ROMO 12 months, ZOL 12 months	Zoledronate	90 patients 12 months of romosozumab (ROMO) followed by 12 months of zoledronate (ZOL)
Group 1 - ROMO 12 months, ZOL 12 months	Romosozumab	90 patients 12 months of romosozumab (ROMO) followed by 12 months of zoledronate (ZOL)
Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 months	Romosozumab	90 patients 6 months of romosozumab followed by 12 months of zoledronate and lastly 6 months of romosozumab.
Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 months	Zoledronate	90 patients 6 months of romosozumab followed by 12 months of zoledronate and lastly 6 months of romosozumab.
Group 3 - ROMO 6 months, ZOL 18 months	Romosozumab	90 patients 6 months of romosozumab followed by 18 months of zoledronate .
Group 3 - ROMO 6 months, ZOL 18 months	Zoledronate	90 patients 6 months of romosozumab followed by 18 months of zoledronate .

Primary Outcome Measures

Name	Time	Method
Change in total hip BMD	24 months	Change in total hip BMD

Secondary Outcome Measures

Name	Time	Method
Change in spine BMD	24 months	Change in spine BMD
Changes in femoral neck BMD	24 months	Change in femoral neck BMD
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	Mean percent change in trabecular bone volume fraction and cortical porosity measured by HR-pQCT at the radius and tibia

Trial Locations

Locations (1)

Department of Endrocinology and Internal Medicine; 🇩🇰 Aarhus, Denmark