Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
64
Countries
1
Sites
1
Diabetes Mellitus and Osteopenia/Osteoporosis
To investigate the effect of Alendronate on bone markers and glycemic markers
Key facts
- Sponsor
- Aalborg University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 15 Aug 2013 → 24 Mar 2026
- Decision date (initial)
- 2024-06-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514148-99-00
- EudraCT number
- 2013-001222-26
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To investigate the effect of Alendronate on bone markers and glycemic markers
Secondary objectives 1
- To compare type 1 and type 2 diabetes. And to compare different methods of assesing bone in diabetics
Conditions and MedDRA coding
Diabetes Mellitus and Osteopenia/Osteoporosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Type 1 diabetes / type 2 diabetes, Age ≥ 50 år, Same medical diabetes treatment the last six months (dose changes is allowed) and HbA1c changes on ± 1 in the same period, HbA1c level≥ 6,7% in the last six months, Body mass index (BMI) between 19 og 35, DXA T-score: -3,5 til -0,5
Exclusion criteria 1
- HbA1C > 10%, Pregnancy, Metal implanted at ancle and wrist at all four ekstremities, Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs, glucocorticoids, lithium and anticonvulsives, Patients with bone disease different from Osteoporosis, Vertebral fracture assessed by VFA, Patients with kidney disease defined by eGFR < 50, Other significant medical disease in unstable phase (like cancer or hyperthyroidism), Heart failure in NYHA class IV, Previous allergic reactions to the trial drug, Previous allergic reactions to tetracyklin, Abnormities in esophagus and other factors, which may delay the transit time in the esophagus, Unable to stand or sit for 30 consecutive minutes, The investigator considers the patient unfit to participate, Patient with no understanding of the extent of the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- HbA1c and BMD
Secondary endpoints 1
- Insulin, plasmaglucose, HOMA-IR, hs-CRP, AGE markers, lipids, adiponectin, PTH, 25 og 1,25 vitamin D, bone specific alkaline phosphatase, FSH, LH, testestoron/østradiol, creatinine, GFR, FGF23, sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL and pentosidine. Urine albumin/creatinine ratio and urine bone markers. HRpQCT scan results. Analysis results by fat tissue-, muscle tissue- and bone biopsies. Life style questionnaire including diet and physical activity.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Alendronat Teva 70 mg tabletter
PRD622448 · Product
- Active substance
- Alendronate Sodium Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- M05BA04 — ALENDRONIC ACID
- Marketing authorisation
- 05-3591
- MA holder
- TEVA SWEDEN AB
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Encapsulated in gelatine capsulas by the Hospital Pharmacy
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aalborg University Hospital
- Sponsor organisation
- Aalborg University Hospital
- Address
- Hobrovej 18-22
- City
- Aalborg
- Postcode
- 9000
- Country
- Denmark
Scientific contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Peter Vestergaard
Public contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Peter Vestergaard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 64 | 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 | 2013-08-15 | 2013-12-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | Denmark | Acceptable 2024-06-20
|
2024-06-26 |