Diabetes Mellitus and Osteopenia/Osteoporosis
Conditions
Interventions
Trade Name: Alendronat Teva (in the study the effect of Alendronate is examined and there may be switched between types)
Product Name: Alendronat
Product Code: Alendronate
Pharmaceutical Form: Capsule
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Alendronate on bone markers and glycemic markers.;Secondary Objective: To compare type 1 and type 2 diabetes. And to compare different methods of assesing bone in diabetics.;Primary end point(s): HbA1c and BMD;Timepoint(s) of evaluation of this end point: HbA1c is evaluated after one and three months and one and two years (the analyses may be done at the end of the study after two years). BMD is measured after one and two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 og 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.;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated by the end of the trial. However scanning results and muscle and fat biopsy results may be evaluated after one year. Like some biochemical may be evaluated after one and three months and one year like the primary endpoint HbA1c. The questionnaire will be filled out and evaluated at baseline, 1 month, 3 months, 1 year and 2 years. | — |
Countries
Denmark
Contacts
Public ContactDepartment of endocrinology
Aalborg University Hospital
Outcome results
None listed