Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre and randomized controlled trial

Abstract Background: Low back pain is one of the most common symptoms of osteoporosis (OP). The pain can seriously affect patients' mood and quality of life; it can also further aggravate bone loss, causing a serious social burden. Minodronate is a third-generation bisphosphonate. Daily oral administration of minodronate significantly reduces levels of bone resorption markers and rapidly improves symptoms of low back pain in patients with OP. Methods: This is a single-centre, randomized, open-label controlled trial with a 24-week duration. Seventy-two eligible patients will be randomly divided into 4 groups. Subjects will be randomized at a 1:1 ratio to receive either minodronate (1 mg/day) or alendronate (10 mg/day) every day, senior women (≥75 years old) and older women (＜75 years old) will be at a ratio of 1:2. The primary outcome is the time required for the Visual Analogue Scale (VAS) score to decline by ≥10 from baseline, and the secondary outcome is the changes in VAS scores from baseline at 1, 2, 4, 6, 8, 12 and 24 weeks after administration and the frequency and dosage of rescue medication,pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of minodronate and alendronate in Chinese postmenopausal OP patients of different ages, and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating). Results and discussion: This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal OP with low back pain. Furthermore, it will be helpful to evaluate the quantitative relationship between bone turnover markers (BTM) and bone mineral density (BMD) in patients with OP underdifferent ages. Trial registration: This study protocol has been registered with ClinicalTrials.gov ID NCT05645289 on December 8th, 2022. The registry name is Peking University Third Hospital. This study protocol was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2022465, 2022.08.09, V2.0). The results will be published in scientific peer-reviewed journals. Trial status: Not yet recruiting. Recruitment is expected to begin in January 2023 and is expected to be completed in June 2024.