Markers of bone in diabetics and the effect of bone treatment.

Phase 1

• Conditions: Diabetes Mellitus and Osteopenia/Osteoporosis; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-001222-26-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-09
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• HbA1C > 10%
• Pregnancy.
• Metal implanted at ancle and wrist at all four ekstremities.
• Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs,
glucocorticoids, lithium og anticonvulsives.
• Patients with bone disease different from Osteoporosis.
• Vertebral fraktur synlig ved 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 tim 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified