A study protocol for exploration and application of surgical pharmaceutical service model in drug treatment management in patients with osteoporosis fracture in China

Jieluan Lu Yi Luo De Cai Yali Wang ^*

• First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong Province, China

Background: Osteoporotic fractures are a grave consequence of osteoporosis, which can be prevented through effective therapeutic strategies, such as anti-osteoporotic medications. However, a multicenter study in China reported that only 20% of elderly patients with hip fractures received appropriate pharmacotherapy post-fracture, resulting in a treatment failure and an increased risk of re-fracture. Pharmacists-led interventions have been provrn effective in osteoporosis management and may address this treatment gap. This study aims to evaluate the impact of pharmacist-led interventions on improving continuation rates of anti-osteoporotic drugs and reducing the re-fracture risk in patients with osteoporotic fracture (Grant Number: YCTJ-2023--15).This single-center, prospective, randomized, controlled trial targets patients aged over 50 years with osteoporotic fracture in China. Eligible participates will be randomized into intervention and control groups in a 1:1 ratio. The control group will receive standard care, while the intervention group will receive standard care plus comprehensive pharmacist-led care, including pharmaceutical ward rounds, medication reconciliation re-fracture risk evaluation, recommendations to physicians, patient education, and counseling. A 2-year follow-up will be conducted to evaluate outcomes through telephone interviews, pharmaceutical clinics, and e-hospital practice. The primary outcome is the continued treatment rates of anti-osteoporotic drugs, defined as the proportions of patients remaining on these medications at each follow-up point. Secondary outcomes include treatment initiation rates, medication adherence, re-fracture rates, use of fall-risk-increasing drugs, bone mineral density (BMD) frequency, incidence of inappropriate medication use and adverse drug reactions (ADRs), and patient satisfaction. Re-fracture rates will be assessed over 2 years, BMD will be measured at baseline, 1 year, and 2 years using dual-energy X-ray absorptiometry (DXA) scans. and ADRs and inappropriate medication use will be monitored through self-reports and medication reconciliation. Patient satisfaction will be evaluated using the Treatment Satisfaction Questionnaire for Medication version II (TSQM-II). Ethical approval was obtained (Number: B-2023-194). The data will be performed using the Statistics Package for the Social Science (SPSS) program, version 23.0. Discussion: This stydy hypothesize that pharmacists-led interventions will enhance treatment outcomes in patients with osteoporotic fracture. This study aims to fill the knowledge gap regarding the effectiveness of pharmacist-led interventions in improving osteoporotic fracture management in China.