Currently submitted to: JMIR Research Protocols
Date Submitted: Dec 4, 2025
Open Peer Review Period: Dec 4, 2025 - Jan 29, 2026
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Efficacy and Safety of Gushuling in Patients with Diabetes Mellitus and Osteoporosis: A Randomized Controlled Trial Protocol
ABSTRACT
Abstract Background：Osteoporosis and diabetes are both prevalent chronic diseases. The complex pathophysiological interactions between glucose metabolism and bone health contribute to an elevated osteoporosis risk in diabetic patients. However, some glucose-lowering medications adversely affect bone metabolism. Herbal formulations have been proposed as complementary interventions, although systematic evidence supporting their use remains limited. Previous studies by our research group indicated that Gushuling (GSL) may improve osteoporotic conditions. Nevertheless, high-quality randomized controlled trials are lacking to clarify the efficacy of GSL for diabetes complicated by osteoporosis. This study evaluates the effectiveness and safety of GSL in managing patients with both diabetes and osteoporosis. Method：This prospective, randomized, single-center clinical trial enrolled 60 participants, who were centrally allocated in a 1:1 ratio to receive either Gushuling (GSL) combined with Caltrate D3 Tablets and Alendronate Sodium Tablets, or Caltrate D3 Tablets and Alendronate Sodium Tablets alone. A 24-week treatment period was followed by a final assessment at week 36, which occurred 12 weeks after treatment discontinuation. The primary outcome was bone mass, measured by bone mineral density (BMD). Secondary outcomes included serum levels of Ca, P, ALP, plasma 25-hydroxyvitamin D3 [25(OH)D3], β-CrossLaps (β-CTx), osteoprotegerin (OPG), MiR-135a-5p, Foxo1, and PTGS2, in addition to blood glucose levels. All statistical analyses were conducted using SPSS 28.0, with no interim analysis performed. Discussion：This trial establishes a methodological framework for evaluating the clinical efficacy, safety, and potential mechanisms of GSL in patients with diabetes and osteoporosis. It also explores expanded avenues for integrating Traditional Chinese Medicine into the comprehensive management of diabetes complicated by osteoporosis. Registration Number of Clinical Trial This study has been registered with the Chinese Clinical Trial Registry under registration number: ChiCTR2400087572.https://www.chictr.org.cn/searchproj.html.Registration date: July 30, 2024.
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