2024-514148-99-00CompletedPhase 4
Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) and the effect of antiresorptive treatment on glycemic markers
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jun 2024
Brief summary (registry, in English)
To investigate the effect of Alendronate on bone markers and glycemic markers
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 7 Jun 2024
- Start date
- 15 Aug 2013
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Osteoporosis
- EU CT number
- 2024-514148-99-00
- EudraCT number
- 2013-001222-26
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 64
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.