Effect of rhPTH(1-34) and alendronate on the treatment of type 2 diabetic bone disease
Abstract
Introduction: Patients with type 2 diabetes mellitus (T2DM) have decreased bone turnover levels. However, there are few studies comparing the anti-osteoporosis effects of anabolic drugs and anti-resorptive drugs in patients with T2DM. Thus, this study was designed to compare the changes in bone mineral density (BMD) and bone turnover levels in mice and postmenopausal osteoporotic patients, both with and without T2DM, following treatment with rhPTH(1-34) or alendronate (ALN).
Methods: In the animal study, the mouse model of T2DM (DM mice) was established by high-fat diet (60% from fat) feeding and streptozotocin injection (100 mg/kg) in C57BL/6 mice. Both DM and control (CON) mice were then randomly assigned to receive either normal saline, rhPTH or ALN treatment. In the clinical study, a single-center, prospective, open-label, randomized controlled clinical trial was conducted. Postmenopausal patients with osteoporosis (OP) and postmenopausal patients with both osteoporosis and type 2 diabetes (DOP) were recruited and randomly assigned to receive either rhPTH(1-34) or ALN treatment for a period of one year. Changes in BMD and bone turnover levels were assessed in all groups.
Results: Compared to CON mice, DM mice exhibited decreased bone mass, impaired bone microstructure and, decreased levels of bone turnover markers, including procollagen type I intact N-terminal (P1NP) and C terminal cross-linking telopeptide of type I collagen (CTX). rhPTH(1-34) could reverse the low…
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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.
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