PDF(Pubmed)
Abstract：
BACKGROUND: Low back pain is one of the most common symptoms of osteoporosis. 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 an oral bisphosphonate that needs to be administered daily. It significantly reduces levels of bone turnover markers (BTMs) and rapidly improves symptoms of low back pain in patients with osteoporosis. Osteoporosis requires long-term treatment, and daily dosing reduces patient compliance. Minodronate has a better safety profile than other bisphosphonates. The objective of the trial is to explore the efficacy and safety of minodronate in the treatment of low back pain in postmenopausal osteoporosis patients.
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. The secondary outcome is the changes in VAS scores from baseline, the frequency and dosage of rescue medication, BTMs, bone mineral density (BMD), and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating).
CONCLUSIONS: This study will provide objective evidence for the efficiency and safety of minodronate. Furthermore, it will be helpful to evaluate the quantitative relationship between BTMs and BMD in patients with osteoporosis under different ages.
BACKGROUND: This study protocol has been registered with ClinicalTrials.gov ID NCT05645289 ( https://clinicaltrials.gov/search?term=NCT05645289 ) on December 8, 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.
METHODS: The protocol was registered at ClinicalTrials.gov (registration number: NCT05645289). Recruitment has started in January 2023 and is still ongoing.
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. The secondary outcome is the changes in VAS scores from baseline, the frequency and dosage of rescue medication, BTMs, bone mineral density (BMD), and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating).
CONCLUSIONS: This study will provide objective evidence for the efficiency and safety of minodronate. Furthermore, it will be helpful to evaluate the quantitative relationship between BTMs and BMD in patients with osteoporosis under different ages.
BACKGROUND: This study protocol has been registered with ClinicalTrials.gov ID NCT05645289 ( https://clinicaltrials.gov/search?term=NCT05645289 ) on December 8, 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.
METHODS: The protocol was registered at ClinicalTrials.gov (registration number: NCT05645289). Recruitment has started in January 2023 and is still ongoing.
摘要：
背景：下腰痛是骨质疏松症最常见的症状之一。疼痛会严重影响患者的情绪和生活质量，还会进一步加重骨丢失，造成严重的社会负担。米诺膦酸盐是需要每日给药的口服双膦酸盐。它显着降低了骨转换标志物（BTM）的水平，并迅速改善了骨质疏松症患者的腰背痛症状。骨质疏松需要长期治疗,和每日剂量降低患者的依从性。米诺膦酸盐具有比其他双膦酸盐更好的安全性。该试验的目的是探讨米诺膦酸钠治疗绝经后骨质疏松症患者腰背痛的有效性和安全性。
方法：这是一个单中心，随机化，为期24周的开放标签对照试验.将72名符合条件的患者随机分为4组。受试者将以1：1的比例随机分配，每天接受米诺膦酸盐（1mg/天）或阿仑膦酸盐（10mg/天）；高级女性（≥75岁）和老年女性（<75岁）的比例为1：2。主要结果是视觉模拟量表（VAS）评分从基线下降≥10所需的时间。次要结果是VAS评分相对于基线的变化，抢救药物的频率和剂量，BTMs,骨矿物质密度（BMD），与基线相比，上消化道（GI）症状评分的变化（包括胃灼热，疼痛,和腹胀）。
结论：本研究将为米诺膦酸钠的有效性和安全性提供客观证据。此外，这将有助于评估不同年龄骨质疏松患者BTM与BMD之间的定量关系。
背景：本研究方案已于2022年12月8日在ClinicalTrials.govIDNCT05645289(https://clinicaltrials.gov/search?term=NCT05645289)注册。注册名称为北京大学第三医院。本研究方案经北京大学第三医院医学科学研究伦理委员会(M2022465,2022.08.09,V2.0)审查批准。结果将发表在科学同行评审的期刊上。
方法：该方案已在ClinicalTrials.gov注册（注册号：NCT05645289）。招聘已于2023年1月开始，目前仍在进行中。
方法：这是一个单中心，随机化，为期24周的开放标签对照试验.将72名符合条件的患者随机分为4组。受试者将以1：1的比例随机分配，每天接受米诺膦酸盐（1mg/天）或阿仑膦酸盐（10mg/天）；高级女性（≥75岁）和老年女性（<75岁）的比例为1：2。主要结果是视觉模拟量表（VAS）评分从基线下降≥10所需的时间。次要结果是VAS评分相对于基线的变化，抢救药物的频率和剂量，BTMs,骨矿物质密度（BMD），与基线相比，上消化道（GI）症状评分的变化（包括胃灼热，疼痛,和腹胀）。
结论：本研究将为米诺膦酸钠的有效性和安全性提供客观证据。此外，这将有助于评估不同年龄骨质疏松患者BTM与BMD之间的定量关系。
背景：本研究方案已于2022年12月8日在ClinicalTrials.govIDNCT05645289(https://clinicaltrials.gov/search?term=NCT05645289)注册。注册名称为北京大学第三医院。本研究方案经北京大学第三医院医学科学研究伦理委员会(M2022465,2022.08.09,V2.0)审查批准。结果将发表在科学同行评审的期刊上。
方法：该方案已在ClinicalTrials.gov注册（注册号：NCT05645289）。招聘已于2023年1月开始，目前仍在进行中。
