osteoporosis
Conditions
Interventions
treatment group:Zuogui Pill or Yougui Pill
control group:placebo
Sponsors
Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects in conformity with the diagnostic criteria of osteoporosis, aged 55 to 75 years old and whose syndrome differentiation were kidney deficiency were included. Furthermore, the subjects should have not received any other treatment options meanwhile. Each participant signs the written informed consent before undergoing any examination or study procedure, in compliance with Good Clinical Practice.
Exclusion criteria
Exclusion criteria: Subjects were excluded if they had any disorders such as primary hyperparathyroidism, Cushings syndrome, premature menopause due to hypothalamic, pituitary, or gonadal insufficiency, poorly controlled diabetes mellitus (HbA1c>8.0%) or other causes of secondary osteoporosis. The trial excluded individuals who have taken bisphosphonates, glucocorticoids, calcitonin, vitamin K, active vitamin D compounds or hormone replacement therapy within the previous 2 months. In addition, serum calcium levels above 2.7 mmol/L or below 2.0 mmol/L, serum creatinine levels above1. 133 umol/L or clinically significant hepatic disorders were also exclusion. Furthermore, subjects that had malignancies, physical or mental disabilities were excluded, as well as lactating or pregnant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar spine BMD (L1-4) and femoral BMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;The ECOS-16 questionnaire;Bone turnover markers; | — |
Countries
China
Contacts
Public ContactYang Feng
Shaanxi University of Chinese Medicine
Outcome results
None listed