Health TrialsbyHealthPanel

The Optimised Use of Romozosumab Study

ConditionOsteoporosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Romosozumab

    Drug

    Romosozumab 210 mg/2.34 ml from baseline to month 11

  • Zoledronate

    Drug

    5 mg/100 ml at month 12

  • Romosozumab

    Drug

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

  • Zoledronate

    Drug

    5 mg/100 ml at month 6

  • Romosozumab

    Drug

    210 mg/2.34 ml from baseline to month 5

  • Zoledronate

    Drug

    5 mg/100 ml at month 5 and month 18

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Group 1 - ROMO 12 months, ZOL 12 monthsActive comparator 2 interventions
Group B: Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 monthsActive comparator 2 interventions
Group C: Group 3 - ROMO 6 months, ZOL 18 monthsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in total hip BMD

Change in total hip BMD

Time frame
24 months

Secondary outcomes

1

Changes in femoral neck BMD

Change in femoral neck BMD

Time frame
24 months
2

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)

Mean percent change in trabecular bone volume fraction and cortical porosity measured by HR-pQCT at the radius and tibia

Time frame
24 months
3

Change in spine BMD

Change in spine BMD

Time frame
24 months

Other outcomes

1

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

Changes in P1NP (blood sample)

Time frame
1, 3, 6, 12, 18, 19, 21 and 24 months
2

Bone resorption and formation - Changes in CTX

Changes in cross-linked C-terminal telopeptide (CTX) (blood sample)

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

Bone resorption and formation - Changes in collagen

Bone turnover marker (BTM) collagen (blood sample)

Time frame
1, 3, 6, 12, 18, 19, 21 and 24 months
4

Bone remodelling and modelling assessed using bone histology (jamshidi biopsy)

Investigate the activation of bone remodelling and modelling-based bone formation by ROMO assessed by bone histology (jamshidi biopsy) at 1 (any group), 6 (any group), 18 (group 3), 19 (group 2) and 24 (group 2) months. Biopsies will be obtained from 15 participants at each timepoint. Investigate the depletion of osteoprogenitor cells during ROMO treatment assessed by molecular bone histology and single-nucleic transcriptomics.

Time frame
Month 1, 6, 18, 19, 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov
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