Overview
Sponsor-declared trial summary
Postmenopausal osteoporosis
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 21 May 2024 → ongoing
- Decision date (initial)
- 2024-03-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Conditions and MedDRA coding
Postmenopausal osteoporosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Postmenopausal women (postmenopausal for at least two years)
- Age ≥ 40 years
- BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)
- At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)
- Diabetes Mellitus type 2
- Treatment with metformin as monotherapy
Exclusion criteria 11
- Treatment for osteoporosis at any time
- Other antidiabetic medication than metformin
- Low-energy vertebral fractures at any time
- Low-energy hip fracture at any time
- Ongoing treatment with systemic glucocorticoids
- Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism)
- Treatment affecting bone, calcium metabolism or muscle
- Active cancer within the last 5 years with the exception of basal cell skin cancer
- Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min
- Unable to read and understand Danish
- Immobility
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Changes in muscle mass and muscle strength from baseline to month 12.
- Changes in insulin sensitivity (Hb1Ac, HOMA-IR, fasting glucose, oral glucose tolerance test (OGTT)) from baseline to month 12.
Secondary endpoints 6
- Changes in DPP-4 and GLP-1 from baseline to month 12.
- Changes in carboxy-terminal collagen crosslinks (CTX) and procollagen type I N-terminal propeptide (PINP) from baseline to month 12.
- Change in lumbar spine BMD from baseline to month 12.
- Change in advanced glycation end products (AGEs) from baseline to month 12.
- Changes in muscle strength from baseline to month 1 and 3.
- Changes in insulin sensitivity (Hb1Ac, HOMA-IR, and fasting glucose) from baseline to month 1 and 3
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP152922 · ATC
- Active substance
- Denosumab
- Substance synonyms
- AMG 162, HLX14, TVB-009, MAB-22
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- M05BX04 — DENOSUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.9 ml millilitre(s)
- Max total dose
- 0.9 ml millilitre(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- 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
- Anne Sophie Sølling
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 40 | 1 |
| 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 | 2024-05-21 | 2024-05-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 2 |
| Protocol (for publication) | Questionnaire diet | 1 |
| Protocol (for publication) | Questionnaire exercise | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Please see appendix 1 | 1 |
| Synopsis of the protocol (for publication) | Protokolresume | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-05 | Denmark | Acceptable 2024-03-22
|
2024-03-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-20 | Denmark | Acceptable 2024-03-22
|
2026-05-20 |