Abstract
BackgroundOsteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects, and the development of safer and more effective treatments is urgently needed. The aim of this study is to evaluate the efficacy and safety of BHH10, a traditional Korean herbal medicine, in the treatment of postmenopausal osteoporosis.Methods/DesignThis is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial and will include 168 postmenopausal women aged 55 years and older with osteoporosis. The participants will be recruited competitively from two sites of the Acupuncture and Moxibustion Department of Kyung Hee University Hospital of Korean Medicine, either Hoegidong or Gangdong in Seoul, Korea. Participants will be assigned randomly to one of two groups, the BHH10 group or the placebo group, in a 1:1 ratio, and will have five scheduled visits. Participants will take two tablets of BHH10 or placebo three times daily for 12 weeks. The primary efficacy outcome is the change in bone mineral density at the lumbar spine (L1–4) between baseline (visit 1) and 12 weeks after randomization (visit 5). Other outcome variables include changes in bone turnover markers, the Deficiency Syndrome of the Kidney Index, EuroQol five-dimension questionnaire score, and laboratory parameters, as well as adverse events.DiscussionTo our knowledge, this will be the first clinical trial to assess the efficacy and safety of BHH10 in postmenopausal women with osteoporosis. It is anticipated that the results will contribute to the development of traditional herbal medicines that can be used to treat osteoporosis in postmenopausal women in Korea. If the superiority of BHH10 over placebo is demonstrated, this study could provide the foundation for a phase III clinical trial. The results of the study will be published in a peer-reviewed journal.Trial registrationClinical Research Information Service, KCT0001842. Registered on 14 March 2016.
Highlights
Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial
It is anticipated that the results will contribute to the development of traditional herbal medicines that can be used to treat osteoporosis in postmenopausal women in Korea
Any significant differences in femoral bone mineral density (BMD), bone turnover marker levels, Deficiency Syndrome of the Kidney Index (DSKI), and EuroQol five-dimension questionnaire (EQ-5D) score in the group receiving BHH10 compared to the group receiving the placebo after 12 weeks of treatment to determine if there is a causal relationship between the primary outcome and the DSKI or EQ-5D score whether BHH10 is a safe treatment based on laboratory parameters, vital signs, and electrocardiography (ECG)
Summary
Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. In 2010, more than 99 million individuals aged 50 years or older in the U.S alone were estimated to have osteoporosis or low bone mass, and this number is projected to increase by 19% by 2020 and by 32% by 2030 [2]. The fifth Korean National Health and Nutrition Examination Survey in 2010 reported a high risk of osteoporotic fracture in 37.7% of postmenopausal women aged 50 years or older [4]. Aggregated data for women aged 55 years or older from 2000 to 2011 in the U.S show that the hospitalization costs for osteoporotic fractures are greater than those for myocardial infarctions, breast cancer, or strokes [5]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
