Comparison of the effects of statins and PCSK9 inhibitors on bone metabolism in patients with type 2 diabetes: a prospective, open-label, randomized controlled study

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: PCSK9 Inhibitor Treatment Group:PCSK9 Inhibitor;Statins Treatment Group:Atorvastatin; CONDITION: Osteoporosis PRIMARY OUTCOME: Lumbar bone density;Total hip bone density;Bone mineral density of the femoral neck; SECONDARY OUTCOME: Bone turnover markers;Fracture incident; INCLUSION CRITERIA: 1.Postmenopausal women aged 65–80 years (including 65 and 80 years) at the time of signing the informed consent form; 2.In generally good health and not dependent on others for daily living activities; 3.Diagnosis of hyperlipidemia meets the diagnostic criteria published by the AACE (2025 edition); 4.Diagnosis of type 2 diabetes meets the diagnostic criteria for type 2 diabetes published by the WHO (1999); 5.Have never used any bone resorption inhibitors, including alendronate sodium, zoledronic acid, ibandronate sodium, and denosumab; 6.Demonstrate good medication adherence; 7.Are able to attend follow‐up visits in a timely manner as required by the study; 8.Are willing to sign a written informed consent form and comply with the study protocol.
Epistemonikos ID: 97c858383d7afd094cdb8e5fdd4052a0fd9af9f9
First added on: Oct 08, 2026