A Randomized, Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy and Safety of Sitagliptin on Bone Measures in Women Affected by Type 2 Diabetes. a Gender-oriented Approach to Address a Gender-specific Frailty: the SLowDOWN (SitagLiptin in Diabetes for Osteoporosis in WomeN) Study
Abstract
Background Bone frailty and fractures are common conditions in patients with type 2 diabetes (T2D) and represent a major cause of morbidity and hospitalization in this population. In women, the postmenopausal period is well known to dramatically impact bone mineralization and metabolism, leading to a higher risk of bone fractures. Additionally, hyperglycemia, oxidative stress, and advanced glycation end-products accumulation, as occur in diabetes, negatively impact bone quality. Thus, the coexistence of T2D in postmenopausal women represents a detrimental condition highly increasing the risk of bone fractures and hospitalization.
Dipeptidyl peptidase 4 inhibitors (DPP4-Is) are a promising class of antidiabetic agents with protective effects on bone in experimental conditions. In vivo, higher DPP4 activity correlates with lower bone mineral density (BMD) in women, and DPP4-Is treatment was associated with favorable bone outcomes in the only meta-analysis available on subjects with T2D. However, whether chronic DPP4-I treatment is capable of improving bone outcomes in women affected by T2D has not been explored yet in the context of a specifically designed clinical trial.
Objectives This study is a superiority, double-blinded, randomized, placebo-controlled clinical trial aiming to investigate the safety and efficacy of 52-week sitagliptin 100 mg therapy in improving bone outcomes in women affected by T2D.
Methods For this purpose, the investigators aim to recruit 132 female…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 132 participants or records.
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