title: The effect of low dose nylestriol-levonorgestrel replacement therapy on bone mineral density in women with postmenopausal osteoporosis.
abstract: OBJECTIVE
  Recently our studies have shown that nylestriol in combination with levonorgestrel prevented bone loss, decreased bone turnover rate and increased the maximal loading of bone without obvious side effects in retinoic acid (RA) induced osteoporotic rats. In addition to the animal experiments, we evaluate the effect of Compound Nylestriol Tablet (CNT) on bone mineral density (BMD) in women with postmenopausal osteoporosis. Compound Nylestriol Tablet, which contains 0.5 mg of nylestriol (cyclopentylethinyl estriol) and 0.15 mg of levonorgestrel per tablet, was authorized as a new anti-osteoporotic agent for clinical trial in postmenopausal osteoporosis.
  
  
  METHODS
  One year's clinical observation was performed in 191 eligible patients who were randomly divided into two groups (A and B). In group A, 119 patients were treated for one year with CNT (one tablet per week) and in group B, 72 patients with placebo. Bone mineral density of lumbar antero-posterior spine (L1-L4), lateral spine, total hip and total forearm positions including radius+ulna at the ultra distal areas, mid areas, and one-third areas, were measured before and after treatment. Biochemical parameters and effects of CNT on uterus, and breast were observed.
  
  
  RESULTS
  We found that patients treated with CNT had a significant decrease of bone loss in total forearm, including radius+ulna at the ultra distal, mid, and 1/3 areas compared with control subjects (all P < 0.05). An improved BMD tendency could be seen at the lumbar spine. There were no differences in the observed biochemical variables. No side-effects on uterus, or mammary glands observed. None of the patients had uterine bleeding or vertebral fractures during one year's CNT treatment.
  
  
  CONCLUSIONS
  These data suggested that CNT is effective, safe and convenient in treating postmenopausal osteoporosis.
authors.affiliation: Institute of Endocrinology & Metabolism, The Second Xiangya Hospital of Central South University, Changsha, Hunan, PR China.
authors.forename: Er-yuan
authors.initials: EY
authors.lastname: Liao
authors.forename: Xiang-hang
authors.initials: XH
authors.lastname: Luo
authors.forename: Xiao-ge
authors.initials: XG
authors.lastname: Deng
authors.forename: Xian-ping
authors.initials: XP
authors.lastname: Wu
authors.forename: Hui-juan
authors.initials: HJ
authors.lastname: Liao
authors.forename: Ping-fang
authors.initials: PF
authors.lastname: Wang
authors.forename: Ji-ping
authors.initials: JP
authors.lastname: Mao
authors.forename: Xu-ping
authors.initials: XP
authors.lastname: Zhu
authors.forename: Gan
authors.initials: G
authors.lastname: Huang
authors.forename: Qi-you
authors.initials: QY
authors.lastname: Wei
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000187:drug effects; D001940:Breast / Q000187:drug effects; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004717:Endometrium / Q000187:drug effects; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000517:prevention & control; D017698:Postmenopause / Q000187:drug effects*; D011446:Prospective Studies; D011800:Quinestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D016912:Levonorgestrel; C010722:nylestriol; D011800:Quinestrol