The effect of oral Semaglutide on bone turnover in patients with T2D: a randomized placebo-controlled clinical trial (SOBER II)

Conditions

Type 2 diabetes

Brief summary

Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.

Detailed description

Change in bone strength, assessed by microindentation, Change in bone formation rate, based on dynamic histomorphometry of bone tissue, Change in bone degradation markers Collagen I, cross-linked C-terminal telopeptide (CTX), Change in bone formation markers osteocalcin and bone alkaline phosphatase, Change in bone mineral density, assessed by DXA scan, Change in trabecular and cortical volumetric bone density and estimated strength (finite element analysis), assessed using second generation high resolution peripheral quantitative CT, Change in fat and lean tissue distribution, assessed by DXA, Change in BMI, Change in HbA1c, Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).

Related papers

No related papers found yet.

Interventions

DRUGSEMAGLUTIDE

DRUGPLACEBO

DRUGTetracycline 250 mg Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.	—

Secondary

Measure	Time frame
Change in bone strength, assessed by microindentation, Change in bone formation rate, based on dynamic histomorphometry of bone tissue, Change in bone degradation markers Collagen I, cross-linked C-terminal telopeptide (CTX), Change in bone formation markers osteocalcin and bone alkaline phosphatase, Change in bone mineral density, assessed by DXA scan, Change in trabecular and cortical volumetric bone density and estimated strength (finite element analysis), assessed using second generation high resolution peripheral quantitative CT, Change in fat and lean tissue distribution, assessed by DXA, Change in BMI, Change in HbA1c, Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).	—

Measure

Time frame

Change in bone strength, assessed by microindentation, Change in bone formation rate, based on dynamic histomorphometry of bone tissue, Change in bone degradation markers Collagen I, cross-linked C-terminal telopeptide (CTX), Change in bone formation markers osteocalcin and bone alkaline phosphatase, Change in bone mineral density, assessed by DXA scan, Change in trabecular and cortical volumetric bone density and estimated strength (finite element analysis), assessed using second generation high resolution peripheral quantitative CT, Change in fat and lean tissue distribution, assessed by DXA, Change in BMI, Change in HbA1c, Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).

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Countries

Denmark

Outcome results

None listed