Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,400
Countries
1
Sites
8
osteoporosis
to investigate the effect on fracture risk of discontinuing alendronate in a randomized controlled study
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2024-07-22
- 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: Others
to investigate the effect on fracture risk of discontinuing alendronate in a randomized controlled study
Secondary objectives 1
- To investigate the power of clinical, biochemichal, cellular or molecular characteristics to predict of pronounced bone loss after discontinuation of Alendronate
Conditions and MedDRA coding
osteoporosis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-510042-24-00 | THE ALENDRONATE DISCONTINUATION STUDY | Odense University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Female, Postmenopausal, Current treatment with Alendronate, Alendronate treatment >3 år AND no previous major osteoporotic fracture OR Alendronate treatment >5 år AND latest major osteporotic fracture > 3 years ago, ** Major osteoprotic fracture is defined as low energy fractures in hip, proximal humerus, distal radius, or vertebral fracture
Exclusion criteria 1
- T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine, Treatment with systemic glucocorticoids for more than two weeks, ongoing or within 12 months, Uncontrolled inflammatory disease, Active malignancy, eGFR < 40 mL/min, Atypical femur fracture (ever), OsteoNecrosis of the Jaw (active), Unable to give inform consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of fragility fractures during the study periode
Secondary endpoints 1
- Changes in BMD spine and hip from inclusion to study end (3 years), Changes in Bone Turnover Markers over the study period (CTX and P1NP),Proportion of patients meeting restart criteria ,Adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1140618 · ATC
- Active substance
- Alendronic Acid
- Substance synonyms
- ALENDRONATE
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10920 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- M05BA04 — ALENDRONIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SCP12626012 · ATC
- Active substance
- Tetracycline Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01AA07 — TETRACYCLINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Pernille Hermann
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Pernille Hermann
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 1,400 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Region Syddanmark
Internal Medicine, Carstensgade 6, 6270, Toender
Odense University Hospital
Endocrinology, J B Winsloews Vej 4, 5000, Odense C
Esbjerg Og Grindsted Sygehus
Endocrinology, Finsensgade 35, 6700, Esbjerg
Hvidovre Hospital
Endocrinology, Kettegaard Alle 30, 2650, Hvidovre
Copenhagen University Hospital
Endocrinology, Ringvej 75, 2730, Herlev
Nordsjaellands Hospital
Endocrinology, Dyrehavevej 29, 3400, Hilleroed
Aalborg University Hospital
endocrinology, Moelleparkvej 4, 9000, Aalborg
Bispebjerg Hospital
endocrinology, Bispebjerg Hospital, Bispebjerg Bakke, Copenhagen
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 | 2025-01-30 | 2025-02-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 1-2EU CT 2023-510042-24 | 1.3 |
| Protocol (for publication) | Dansk-SF-36-juni-99-v-1-1 | 1 |
| Protocol (for publication) | pdf_denmark-danish-eq-5d-5l-paper-self-complete-v1-id-24788 | 1 |
| Recruitment arrangements (for publication) | Henvendelsesmail_alexis_ver1_1 | 1 |
| Recruitment arrangements (for publication) | Henvendelsesmail_alexis_ver1_1TandT | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_ALEXIS | 1 |
| Subject information and informed consent form (for publication) | dine rettigheder | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults body composition and questionnaire | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults bone types | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults physical test | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ALEXIS | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ALEXIS_BoneBiopsySubstudy | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ALEXIS_osteoclastsubstudy | 1 |
| Subject information and informed consent form (for publication) | L1_SIS bone microarchitecture and muscles v1_0 13062025 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ALEXIS__BoneBiopsySubstudy_ver1_1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ALEXIS_osteoclastsubstudy_ver1_1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ALEXIS_osteoclastsubstudy_ver1_1TandT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ALEXIS_ver1_1 | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_ALEXIS_ver1_1TandT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Alendronat_smpc | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DK 2023-510042-24 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-09 | Denmark | Acceptable 2024-07-12
|
2024-07-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-18 | Denmark | Acceptable 2025-08-08
|
2025-08-08 |