Consultant
Morten Frost
Endocrinology
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.05.2024 | |
| Slut | 01.05.2028 | |
The Optimised Use of Romozosumab Study The OPTIMIST Study
Short summary
The skeletal effects of romosozumab are caused by increased modelling and remodeling-based bone formation and inhibition of bone resorption. OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial based on two hypotheses: Treatment with romosozumab for 6 months, zoledronate for 12 months, and romosozumab for 6 months results in larger gains in BMD than romosozumab for 6 or 12 months followed by zoledronate for a total of 24 months of treatment
Rationale
Following demonstration of fracture preventive efficacy, romosozumab for 12 consecutive months was recently introduced as a standard treatment of osteoporosis in postmenopausal women with a fragility fracture in Denmark. Clinical studies demonstrate that the bone anabolic effect of romosozumab is observed within the first 6 months of treatment, however, there is evi-dence to suggest that the anabolic response may reappear after an interval with antiresorptive or no treatment with a second course of romosozumab, resulting in an overall longer period of enhanced bone formation leading to higher gains in bone mineral density. The ambition of the OPTIMIST study is to optimise clinical use of romosozumab in patients with osteoporosis and fractures by demonstrating if romosozumab treatment results in higher gains in BMD if administered for 6 months before and after anti-resorptive treatment than observed with the current treatment regimen, and whether shorter treatment with romosozumab followed by antiresorptive treatment results in similar gains in BMD as observed with current practice. If re-peated treatment with romosozumab is superior in increasing BMD, this may have implications for clinical practice. Furthermore, if romosozumab treatment for a shorter duration has a similar effect on BMD as observed with full-length of romosozumab treatment, future clinical manage-ment may include a shorter duration of romosozumab treatment.
Description of the cohort
This study will include 270 treatment naïve postmenopausal women. 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. Exclusion criteria (selected): Osteoporosis treatment including hormone replacement therapy within the last 5 years; Metabolic bone disease. The patients will be recruited from the outpatient clinics and the DXA units to which patients are referred from their general practitioner or fracture liaison services (FLS) at: Department of Endocrinology, Odense University Hospital; Department of Endocrinology and Internal Medicine, Aarhus University Hospital; Department of Endocrinology, Køge Hospital; Department of Endocrinology, Hvidovre Hospital; Department of Endocrinology, Bispebjerg Hospital
Data and biological material
Blood and bone samples; bone mass assessed using DXA and HRpQCT; bone turnover markers; OGTT (glucose, insulin measures).
Collaborating researchers and departments
Please see above