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Clinical Trials/EUCTR2013-001222-26-DK
EUCTR2013-001222-26-DK
Active, not recruiting
Phase 1

Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) andthe effect of antiresorptive treatment on glycemic markers.

Aalborg University Hospital0 sites64 target enrollmentJuly 9, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes Mellitus and Osteopenia/Osteoporosis
Sponsor
Aalborg University Hospital
Enrollment
64
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2013
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Not specified

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