Overview
Sponsor-declared trial summary
osteoporosis
The main objective of the OPTIMIST study is to identify the optimal use of romosozumab for the treatment of osteoporosis by investigating 3 different treatment strategies.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 26 Sep 2023 → ongoing
- Decision date (initial)
- 2023-08-10
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective of the OPTIMIST study is to identify the optimal use of romosozumab for the treatment of osteoporosis by investigating 3 different treatment strategies.
Secondary objectives 1
- to investigate if romosozumab affects insulin sensitivity
Conditions and MedDRA coding
osteoporosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- postmenopausal women
- Osteoporosis defined as BMD T-score < -2.5 at spine, total hip or femoral neck
- Osteoporotic fracture at spine, hip, pelvis, forearm, or humerus within 3 years after the age of 50 years
Exclusion criteria 6
- Osteoporosis treatment within the last 5 years
- Metabolic bone disease
- Known disorders affecting bone metabolism
- Ongoing treatment with glucocorticoids
- Estimated glomerular filtration rate (eGFR) < 35 ml/min
- Contraindications or intolerance to romosozumab or zoledronate
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in total hip BMD at 24 months
Secondary endpoints 6
- Change in lumbar spine and femoral neck BMD at 24 months
- Change in HRpQCT derived bone microarchitecture at 24 months
- Changes in bone turnover markers during the course of the trial
- Bone modelling and remodelling assessed by histomorphometry of bone biopsies
- Increase in number and composition of osteoprogenitor cells in the bone marrow
- Effect of romosozumab on glucose metabolism and interaction with changes in bone turnover markers and BMD
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Aclasta 5 mg solution for infusion
PRD10109345 · Product
- Active substance
- Zoledronic Acid
- Substance synonyms
- ZOLEDRONATE
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- M05BA08 — ZOLEDRONIC ACID
- Marketing authorisation
- EU/1/05/308/001
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EVENITY 105 mg solution for injection in pre-filled syringe
PRD7763545 · Product
- Active substance
- Romosozumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 210 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- M05BX06 — -
- Marketing authorisation
- EU/1/19/1411/003
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Bente Langdahl
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Bente Langdahl
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 270 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-09-26 | 2023-09-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CT-2023-505940-20-00 OPTIMIST protocol | 13 |
| Recruitment arrangements (for publication) | Annonce OPTIMIST_appendix 5 | 1 |
| Recruitment arrangements (for publication) | Invitation OPTIMIST_appendix 4 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF DK | 2 |
| Subject information and informed consent form (for publication) | OPTIMIST Deltagerinformation_appendix 3 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | aclasta-epar-product-information_en_appendix 2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | evenity-epar-product-information_en_appendix 1 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK CT-2023-505940-20-00 clean | 4 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-24 | Denmark | Acceptable 2023-08-10
|
2023-08-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-27 | Denmark | Acceptable 2023-08-10
|
2023-11-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-17 | Denmark | Acceptable 2025-03-11
|
2025-03-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-31 | Denmark | Acceptable 2025-05-09
|
2025-05-10 |