1.A clinical study of adefovir dipivoxil treatment for chronic hepatitis patients with cirrhosis in their decompensation period.
Qing YANG ; Zuo-jiong GONG ; Dan-feng HU
Chinese Journal of Hepatology 2009;17(7):515-519
OBJECTIVETo evaluate the efficacy and safety of 96 weeks adefovir dipivoxil (ADV) treatment for chronic hepatitis patients with cirrhosis in their decompensation period.
METHODSChronic hepatitis patients with cirrhosis in their decompensation period were randomly divided into two groups. An ADV group: patients treated with 10 mg ADV per day; a lamivudine (LMV) group: patients treated with 100mg LMV per day. The course of treatment lasted 96 weeks. Serum levels of ALT, AST, Alb, Tbil, HbeAg, HBV DNA, PCIII, IVC, LN and HA, renal function, Child-Pugh scores, drug adverse reactions and complication during the treatment of the two groups were analyzed.
RESULTSDuring the two-year treatment, the proportions of patients with a return to normal liver function were similar in both groups. With the treatment prolonged, serum HBV DNA levels of the patients in adefovir dipivoxil group decreased gradually. The HBV DNA level in some lamivudine-treated patients was increased. The sero-conversion rate of HBeAg/HBeAb of the patients in the two groups was increased with the prolongation of the treatment. At 96 weeks, the ratio of emerging virus-resistant strains was lower in the adefovir dipivoxil group than in the lamivudine group. The levels of the serum markers of hepatic fibrosis of the patients in the two groups remained low. Child-Pugh scores of the patients in the two groups were significantly improved. No significant difference in the total incidence of complications between the two groups was noticed. Each of the two groups had a patient with liver-kidney syndrome and other serious complications.
CONCLUSIONThe efficacy and safety of adefovir dipivoxil and lamivudine treatment for the above patients are similar, but the ratio of emerging virus-resistant strains of the adefovir dipivoxil treatment group is lower than that of lamivudine treatment group.
Adenine ; adverse effects ; analogs & derivatives ; therapeutic use ; Administration, Oral ; Adult ; Aged ; Antiviral Agents ; adverse effects ; therapeutic use ; Collagen ; blood ; DNA, Viral ; blood ; Drug Resistance, Viral ; Female ; Hepatitis B e Antigens ; blood ; Hepatitis B virus ; drug effects ; genetics ; Hepatitis B, Chronic ; blood ; complications ; drug therapy ; Humans ; Lamivudine ; adverse effects ; therapeutic use ; Liver Cirrhosis ; blood ; drug therapy ; etiology ; Liver Function Tests ; Male ; Middle Aged ; Organophosphonates ; adverse effects ; therapeutic use ; Time Factors ; Treatment Outcome
2.The curative effect and safety of collagen sponge with different pH and content of protein implanted into orthopedic bone defect.
Gang TONG ; Jing LEI ; Cuihong ZHONG ; Weixin CAI ; Xuewei LIN
Journal of Biomedical Engineering 2012;29(6):1125-1130
This paper presents a 3mm fracture model of radial bone of rabbits using operation method. The bone defect was treated with collagen sponge with different pH and different content. After the operation, the body temperature, blood routine measurement, serum antibody, X-ray examination and histological observation in each group were examined to evaluate and study the curative effect and safety of collagen sponge. Collagen sponge had a good result of safety, but there was slightly change in blood routine, serum antibody, and histological observation, etc, with the pH changing and different content of collagen. The results showed that there was no obvious influence of safety to tissues after treatment of the collagen sponge at different pH implanted into bone defect. Collagen sponge at lower pH could promote the healing of bone defect partly, while the safety of collagen sponge with lower content was better.
Animals
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Collagen Type I
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adverse effects
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chemistry
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therapeutic use
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Hydrogen-Ion Concentration
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Male
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Prostheses and Implants
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Proteins
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analysis
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Rabbits
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Radius Fractures
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surgery
3.Phase III clinical study of zoledronic acid in the treatment of pain induced by bone metastasis from solid tumor or multiple myeloma.
Mei DONG ; Feng-Yi FENG ; Yang ZHANG ; Guang-Ru XIE ; Ya-Jie WANG ; Ji-Wei LIU ; San-Tai SONG ; Qing-Hua ZHOU ; Jun REN ; Shun-Chang JIAO ; Jin LI ; Xiu-Wen WANG ; Qiang CHEN ; Zhe-Hai WANG ; Nong XU ; Ji-Feng FENG
Chinese Journal of Oncology 2008;30(3):215-220
OBJECTIVETo evaluate the efficacy and safety of zoledronic acid in the treatment of bone pain in patients with bone metastasis from solid tumor or multiple myeloma.
METHODSA randomized, double-blind, double-simulated and multi-center phase III clinical trail with pamidronate as control was conducted. Patients with moderate to severe bone pain (VAS > 50 mm) induced by solid tumor or multiple myeloma were randomized to receive intravenous zoledronic acid 4 mg or pamidronate 90 mg. Then the change of VAS and urinary NTX/Cr and CTX/Cr were observed in two groups.
RESULTSFrom July 2005 to September 2006, 228 patients with bone pain induced by bone metastasis from 15 cancer centers were randomize into two groups: 116 patients in zoledronic acid group and 112 patients in pamidronate group. The VAS value was decreased gradually after treatment in these two groups. Significant improvement in bone pain after treatment were observed both in zoledronic acid group and the control group when compared with baseline VAS on D8 (-11.77% vs. -10.87%), D15 (-24.60% vs. -21.06%) and D28 (-32.37% vs. -31.26%) (P< or =0.0001), but no significant difference existed between two groups (P =0.6587). Compared with baseline, urine NTX/Cr and CTX/Cr level were decreased rapidly after treatment in both groups, the nadir was on D8, the median decreased on D28, which was -36.9% vs. -32.1% for NTX/Cr (P = 0.7922) and -63.2% vs. -47.9% for CTX/Cr (P =0.834). The frequently observed adverse events were pyrexia (19.0% vs. 31.3%), vomiting (6.0% vs. 8.9%), nausea (4.3% vs. 4.5%), fatigue (3.4% vs. 2.7%) and constipation (2.6% vs. 1.8%) in the two groups. Compared with baseline, the serum creatinine level was not significantly increased throughout the study.
CONCLUSIONIntravenous injection of 4 mg zoledronic acid can significantly reduce bone pain and bone resorption marker in urine in the Chinese patients with bone metastasis from solid tumor or multiple myeloma, which is tolerable and also comparable to pamidronate in the efficacy and safety.
Adult ; Aged ; Analgesics ; adverse effects ; therapeutic use ; Bone Density Conservation Agents ; adverse effects ; therapeutic use ; Bone Neoplasms ; complications ; secondary ; Breast Neoplasms ; pathology ; Collagen Type I ; urine ; Colorectal Neoplasms ; pathology ; Creatinine ; urine ; Diphosphonates ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Fever ; chemically induced ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Lung Neoplasms ; pathology ; Male ; Middle Aged ; Multiple Myeloma ; complications ; Pain Measurement ; Pain, Intractable ; drug therapy ; etiology ; urine ; Peptides ; urine ; Prospective Studies ; Vomiting ; chemically induced
4.Effects of Corbrin Shugan capsule on dimethylnitrosamine-induced hepatic fibrosis in rats.
Ying QIAN ; Xu-Chun FU ; Rong HU ; Li-Mei SHEN ; Hai-Bo BAI
Journal of Zhejiang University. Medical sciences 2013;42(5):561-566
OBJECTIVETo investigate the effects of Corbrin Shugan capsule on dimethylnitrosamine (DMN)-induced hepatic fibrosis in rats.
METHODSHepatic fibrosis was induced by DMN in AD rats. The serum concentrations of III pro-collagen (III PC),laminin (LN) and tissue inhibitor of metalloproteinase-1(TIMP-1) were determined with ELISA. The concentration of albumin (ALB) in sera and the content of hydroxyproline (Hyp) in liver tissues were determined with chemical colorimetric and HPLC, respectively. The fibrosis area was measured with Motic Med 6.0 digital medical image analysis system.
RESULTSCompared to model group the high-dose (450 mg kg(-1)),mid-dose (270 mg kg(-1)) and low-dose (90 mg kg(-1)) groups of Corbrin Shugan capsule had significantly lower serum content of III PC [34.46 ± 13.95),(36.15 ± 9.46), and (40.58 ± 7.72)ng ml(-1) compared with (49.38 ± 10.95)ng ml(-1),P<0.05 or P<0.01],TIMP-1 [(16.65 ± 4.24),(16.66 ± 4.34),and (18.99 ± 6.05)ng ml(-1) compared with (30.84 ± 14.48)ng ml(-1), P<0.05 or P<0.01], LN [(12.94 ± 4.29), (12.96 ± 3.21),and (15.32 ± 8.00)ng ml(-1) compared with (30.22 ± 17.00)ng ml(-1),P<0.05 or P<0.01] and smaller hepatic fibrosis area [(0.02240 ± 0.01337), (0.02176 ± 0.01460) and (0.02384 ± 0.01405)μm(2) compared with vs (0.03929 ± 0.01732)μm2, P<0.05 or P<0.01]; the high-dose and mid-dose groups of Corbrin Shugan capsule had significantly lower content of Hyp in liver tissues [(0.77 ± 0.09) and (0.81 ± 0.09)μg μmg(-1) compared with (1.06 ± 0.33)μg mg(-1),P<0.05 or P<0.01]; and the high-dose group of Corbrin Shugan capsule significantly increased the content of ALB in sera [(34.02 ± 4.17)g L(-1) compared with (30.25 ± 4.21)g L(-1),P<0.05].
CONCLUSIONCorbrin Shugan capsule is effective in treatment of DMN-induced hepatic fibrosis in rats.
Albumins ; metabolism ; Animals ; Capsules ; Collagen Type III ; blood ; Dimethylnitrosamine ; adverse effects ; Drugs, Chinese Herbal ; therapeutic use ; Hydroxyproline ; metabolism ; Laminin ; blood ; Liver Cirrhosis, Experimental ; drug therapy ; Male ; Rats ; Rats, Sprague-Dawley ; Tissue Inhibitor of Metalloproteinase-1 ; blood
5.Experimental study of saikosaponin-D (SSd) on lipid peroxidation of hepatic fibrosis on rat.
Yan HE ; Zhi-Feng HU ; Ping LI ; Cheng XIAO ; Yu-Wu CHEN ; Ke-Ming LI ; Jing-Zhen GUO ; Lin PAN ; Jia-Peng XIONG
China Journal of Chinese Materia Medica 2008;33(8):915-919
OBJECTIVETo study the effect of SSd on lipid peroxidation during experimental hepatic fibrosis progression.
METHODThe experimental models of hepatic fibrosis were induced by intraperitoneal injection of dimethylnitrosamine (DMN) on rats. SSd was administered by intraperitoneal injection for 4 weeks. Serum was analyzed for alanine and aspartate aminotransferase (ALT and AST), hyaluronic acid (HA), laminin (LN), collagen IV (IV-C), malonaldehyde (MDA) and superoxide dismutase (SOD) activities. Liver samples were measured for MDA contents and SOD activities in normal group, model group and SSd group.
RESULTSSd significantly decreased ALT and AST activities and lowered HA, LN and IV-C contents. It enhanced SOD activities in liver, while reduced MDA contents both in serum and liver.
CONCLUSIONSSd has obvious effects of protecting hepatocytes and resisting hepatic fibrosis, and the mechanism may be associated with its anti-lipid peroxidation effect.
Animals ; Aspartate Aminotransferases ; blood ; Collagen Type IV ; blood ; Dimethylnitrosamine ; adverse effects ; Hyaluronic Acid ; blood ; Laminin ; blood ; Lipid Peroxidation ; drug effects ; Liver Cirrhosis ; blood ; chemically induced ; drug therapy ; metabolism ; Malondialdehyde ; blood ; Oleanolic Acid ; analogs & derivatives ; pharmacology ; therapeutic use ; Rats ; Saponins ; pharmacology ; therapeutic use ; Superoxide Dismutase ; blood
6.Efficacy and Safety of Porcine Collagen Filler for Nasolabial Fold Correction in Asians: A Prospective Multicenter, 12 Months Follow-up Study.
Jung Ho LEE ; Yong Sung CHOI ; Sue Min KIM ; Young Jin KIM ; Jong Won RHIE ; Young Joon JUN
Journal of Korean Medical Science 2014;29(Suppl 3):S217-S221
Recently, injectable dermal fillers have become important alternatives to surgical procedures for the correction of facial wrinkles. Bovine collagen is the first approved material for filler injection, and several studies have shown its efficacy. However, the risk of developing an allergic reaction and xenogenic transmission of bovine spongiform encephalopathy remain among its disadvantages. In this randomized, double-blinded, split-face study, we compared the efficacy and safety of a porcine collagen filler (TheraFill(R)) with that of a bovine collagen filler (KOKEN(R)) for nasolabial fold correction. A total of sixty one patients with mild to severe nasolabial fold were randomized to receive TheraFill(R) and KOKEN(R) on contralateral sides of the face. During the 12-month follow-up period, improvement in the Wrinkle-Severity Rating Scale score was slightly higher in TheraFill(R) group than KOKEN(R) group, although the difference was not statistically significant. No serious adverse reactions were observed and both materials were tolerable in most cases. In conclusion, the long-term effect of TheraFill(R) on nasolabial fold correction was comparable to that of KOKEN(R), and it may be a good alternative to bovine collagen filler.
Adult
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Aged
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Animals
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Biocompatible Materials/therapeutic use
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Cattle
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Collagen/adverse effects/*therapeutic use
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Dermatologic Surgical Procedures/*methods
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Double-Blind Method
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Face/surgery
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Female
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Follow-Up Studies
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Humans
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Injections, Intradermal
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Male
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Middle Aged
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Nasolabial Fold/*surgery
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Prospective Studies
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Skin Aging
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Surgery, Plastic/*methods
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Swine
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Treatment Outcome
7.Oleuropein prevents the progression of steatohepatitis to hepatic fibrosis induced by a high-fat diet in mice.
Sung Woo KIM ; Wonhee HUR ; Tian Zhu LI ; Young Ki LEE ; Jung Eun CHOI ; Sung Woo HONG ; Kwang Soo LYOO ; Chan Ran YOU ; Eun Sun JUNG ; Chan Kun JUNG ; Taesun PARK ; Soo Jong UM ; Seung Kew YOON
Experimental & Molecular Medicine 2014;46(4):e92-
Nonalcoholic steatohepatitis (NASH) is characterized by hepatocyte injury and inflammatory cell infiltration, which has been linked to peripheral insulin resistance and increased levels of triglycerides in the liver. The purposes of this study were to establish a mouse model of NASH by feeding mice a 60% high-fat diet (HFD) and to demonstrate the anti-fibrotic effects of oleuropein, which has been shown to have anti-oxidant and anti-inflammatory properties, in this HFD-induced mouse model of NASH. C57BL/6 mice were divided into three groups: a regular diet group (Chow), a HFD group and an oleuropein-supplemented HFD group (OSD), which was fed a 0.05% OSD for 6 months. The effects of oleuropein in this model were evaluated using biochemical, histological and molecular markers. The expression levels of alpha-smooth muscle actin (alpha-SMA)and collagen type I in the HFD and OSD groups were evaluated using real-time PCR and western blotting. The body weight, biochemical marker levels, nonalcoholic fatty liver disease activity score, homeostasis model of assessment-insulin resistance (HOMA-IR) and leptin levels observed in the HFD group at 9 and 12 months were higher than those observed in the Chow group. The HOMA-IR and leptin levels in the OSD group were decreased compared with the HFD group. In addition, alpha-SMA and collagen type I expression were decreased by oleuropein treatment. We established a NASH model induced by HFD and demonstrated that this model exhibits the histopathological features of NASH progressing to fibrosis. Our results suggest that oleuropein may be pharmacologically useful in preventing the progression of steatohepatitis and fibrosis and may be a promising agent for the treatment of NASH in humans.
Actins/genetics/metabolism
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Animals
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Antihypertensive Agents/*therapeutic use
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Collagen Type I/genetics/metabolism
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Diet, High-Fat/*adverse effects
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Fatty Liver/*drug therapy/etiology/metabolism
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Fibrosis/etiology/metabolism/prevention & control
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Iridoids/*therapeutic use
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Leptin/genetics/metabolism
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Liver/metabolism/pathology
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Mice
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Mice, Inbred C57BL
8.Preliminary study of effects and mechanisms of qingpeng paste on type II collagen-induced arthritis in rats.
Chao-yong HE ; Nan LI ; Jie MA ; Li-hua CHEN ; Wei-dong LI
China Journal of Chinese Materia Medica 2008;33(12):1455-1458
OBJECTIVETo investigate the effect of Qingpeng paste (QP) on collagen-induced arthritis (CIA) in rats.
METHODCIA was established in female Wistar rats with injection of type II bovine collagen at the base of the tail of animals. CIA rats were treated daily with external administration of different doses of QP or voltaren beginning on the day after the onset of arthritis (day 1) until day 20. Paw swelling rate and the serum levels of IL-1 beta were determined. Moreover, the expression of TNF-alpha and IL-alpha and histopathological changes in the arthritic joints were also observed.
RESULTQP markedly suppressed the paw swelling rate of arthritic rat, reduced the expression of TNF-alpha and IL-alpha in synovial membrane. Histopathological changes in the arthritic joints were also significantly ameliorated in the QP-treated versus vehicle-treated rats. However, the elevated serum levels of IL-1 beta in arthritic rats were not influenced by QP.
CONCLUSIONThe present findings demonstrate the protective property of QP on collagen-induced arthritis, mechanisms underlying it may be related to reduce the expression of IL-1alpha and TNF-alpha in synovial membrane.
Animals ; Arthritis, Rheumatoid ; chemically induced ; drug therapy ; metabolism ; pathology ; Collagen Type II ; adverse effects ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Female ; Gene Expression Regulation ; drug effects ; Interleukin-1alpha ; metabolism ; Interleukin-1beta ; metabolism ; Rats ; Rats, Wistar ; Synovial Membrane ; drug effects ; metabolism ; Tumor Necrosis Factor-alpha ; metabolism
9.Prevention and treatment of aromatase inhibitor-associated bone loss by shugan jiangu recipe in postmenopausal women with breast cancer: a clinical study.
Yuan-Qing LI ; Hong SUN ; Dong XUE ; Yi-Chen XU ; Zhan-Dong LI ; Wei WANG ; Ping-Ping LI
Chinese Journal of Integrated Traditional and Western Medicine 2014;34(9):1064-1068
OBJECTIVETo study the effect of Shugan Jiangu Recipe (SJR) on bone mineral density (BMD) and serum bone metabolic biochemical markers in postmenopausal breast cancer patients with osteopenia.
METHODSTotally 38 patients of postmenopausal women with breast cancer, who received aromatase inhibitors (AIs), were assigned to the treatment group (21 cases) and the control group (17 cases) by using random digit table. All patients took Caltrate D Tablet (containing Ca 600 mg and Vit D3 125 IU), one tablet daily. Patients in the treatment group took SJR, 6 g each time, twice daily for 6 successive months. The bone mineral density (BMD) level was detected before treatment and at months 6 after treatment. Levels of bone alkaline phosphatase (BALP), bone gla protein (BGP), tartrate-resistant acid phosphatase (TRAP), and C-terminal telopeptide of type II collagen (CTX-II) were detected by enzyme linked immunosorbent assay (ELISA). The drug safety was also assessed.
RESULTSCompared with before treatment, BMD of L2-4 and femur neck obviously increased in the treatment group at month 6 after treatment (P < 0.01), serum BALP and TRAP decreased (P < 0.05). Compared with before treatment, BMD of L2-4 and femur neck obviously decreased in the control group at month 6 after treatment (P < 0.05), serum BALP and TRAP increased (P < 0.01). Compared with the control group, lumbar and femur neck BMD obviously increased, serum levels of BGP and BALP obviously decreased, and serum levels of CTX-II and TRAP obviously increased in the treatment group at month 6 after treatment (P < 0.01). No serious adverse event occurred during the treatment period. Bone fracture occurred in one case of the control group (5.8%).
CONCLUSIONSJR could attenuate bone loss of postmenopausal women with breast cancer who received AIs, increase BMD and improve abnormal bone metabolism.
Acid Phosphatase ; blood ; Aged ; Alkaline Phosphatase ; blood ; Aromatase Inhibitors ; adverse effects ; Bone Density ; drug effects ; Bone and Bones ; drug effects ; metabolism ; Breast Neoplasms ; drug therapy ; metabolism ; Collagen Type II ; blood ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Isoenzymes ; blood ; Middle Aged ; Osteocalcin ; blood ; Osteoporosis, Postmenopausal ; chemically induced ; prevention & control ; Peptide Fragments ; blood ; Tartrate-Resistant Acid Phosphatase