A pilot clinical trial was conducted after the in-vivo and in-vitro studies: Eight subjects fulfilled the inclusion criteria were recruited. However, the liver function tests of three subjects out of eight were found to be abnormal with elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level, which was not reported in previous toxicity test. The trial was suspended immediately and a follow-up test showed that the elevated AST and ALT level had reverted back to normal within one month after termination of OPR intake. Although we could not accomplish a RCT, the pilot study revealed potential hepatotoxicity of OPR on human beings and it would raise the safety awareness of investigators on the use of herbal remedies in future clinical studies. / After the in-vivo and in-vitro studies, a double-blinded, randomized, placebo-controlled clinical trial (RCT) was planned. Due to a lack of a Chinese version of instrument to measure osteoporosis-specific quality of life, an English version of the Osteoporosis-Targeted Quality of Life Questionnaire (OPTQoL) was translated into Chinese and linguistically validated according to the standard guideline. The newly formed Chinese OPTQoL can be used to assess the impact of new interventions on quality of life among Chinese osteoporosis patients. / Association of the incidence of postmenopausal osteoporosis and Kidney-Vacuity Syndromes in TCM was investigated with the aid of a Kidney-Vacuity Syndromes scoring questionnaire. In the study, postmenopausal women, who suffered from deficiency of kidney "qi" and kidney "essence", had a significantly higher incidence of osteoporosis. These findings strongly supported that replenishing kidney qi and kidney essence was a logical therapeutic principle in the formulation of OPR. / In conclusion, this study investigated the use of TCM on the treatment of postmenopausal osteoporosis in a systematic manner. It started from herbal formulation, basic science studies to clinical trial. It revealed beneficial effects of OPR on bones through in-vivo and in-vitro studies and demonstrated certain possible mechanism behind. On the other hand, the hepatotoxicity of OPR on human beings was also exposed and had not been reported in previous toxicity tests. The study provided valuable clinical data for other investigators on the potential hazards of herbal remedies although they had been validated as safe and effective in pre-clinical stage. / In search for safe, effective and low-priced medicine, the public have turned their attention to Traditional Chinese Medicine (TCM). Extensive experience has been accumulated in TCM regarding the diagnosis and treatment of osteoporosis, which often involves the prescription of kidney-tonifying herbs. Therefore, the aim of the study, firstly, was to explore the association of the incidence of postmenopausal osteoporosis and Kidney-Vacuity Syndromes in TCM, so as to formulate a rational kidney-tonifying herbal formula for osteoporosis research (OPR). Secondly, the effect of the formula was evaluated by in-vitro and in-vivo studies. Thirdly, the Osteoporosis-Targeted Quality of Life Questionnaire was linguistically validated from English to Chinese, which was expected to be one of the outcome measurement tools in future clinical trials. Lastly, a pilot clinical study was performed, which revealed some potential hazards of the formula on human beings which have not been shown in previous works. / Osteoporosis is a skeletal disorder which leads to an increased risk of bone fracture, disability or even death. It has become a major public health threat and the worldwide incidence of osteoporotic fracture is projected to increase two fold within the next 50 years. Postmenopausal women, being affected by a lack of estrogen, face a much higher risk of the disease. This study would therefore focus on type I osteoporosis (i.e. postmenopausal osteoporosis). Although current medications can slow down the bone deterioration process, their side effects and high cost had impaired patients' compliance with long term treatment. / The effect of OPR for the treatment of postmenopausal osteoporosis was then evaluated by in-vitro and in-vivo studies. In the in-vivo study, an osteoporosis model was established by performing ovariectomy on the four-week-old C57BL/6 mice. A high bone turnover rate was induced and OPR successfully slowed down the high turnover rate of bones by decreasing bone formation and resorption process without increasing the uterine linings. However, its beneficial effect on bones could not be detected on bone mineral density measurement. / The potential mechanism of action of OPR on bones was explored by in-vitro study. OPR was shown to induce cell proliferation and differentiation of osteoblast-like UMR 106 cells. Furthermore, the estrogenic activity of OPR was detected by MCF-7 cell line, which has been stably transfected with estrogen responsive elements (ERE). OPR was shown to possess an estrogenic activity in a dose dependent manner and was comparable to the positive control at a concentration of 200 and 1000 mug/ml. The induced estrogenic activity by OPR may be associated with the presence of phytoestrogen within the herbal formula. These findings suggested that the beneficial effect of OPR on bones might relate to its direct positive effect on osteoblast and its estrogenic-like activity. / Liong, Ching. / Adviser: Chun-tao Che. / Source: Dissertation Abstracts International, Volume: 73-03, Section: B, page: . / Thesis (Ph.D.)--Chinese University of Hong Kong, 2009. / Includes bibliographical references (leaves ). / Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Electronic reproduction. [Ann Arbor, MI] : ProQuest Information and Learning, [201-] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Abstract also in Chinese.