Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This proposed study was designed to investigate the prevalence of a 5-year incident osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and examined.
In 2007-2008 study(Published article about this study could be found in Pubmed, PMID: 24760246), 2070 participants were recruited in this cohort, and 837 subjects (40%) were diagnosed as osteoporosis. After 5 years, 1242 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained at the 5-year follow up. We estimate that around 625 subjects would be diagnosed as osteoporosis. The remaining works include blood sample test (25(OH)D, CTX and P1NP),spine x-ray films reading, data input and statistical analysis, paper writing and publication.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fracture group | Other | Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
|
| non-fracture group | Other | Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionaire survey | Other | We used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-vertebral Fracture Incidence | Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975). | 5 year |
| Vertebral Fracture Incidence | Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975) | 5 year |
| Bone Mineral Density | bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland) | 5 year |
| Bone Turnover Markers and 25(OH)D | C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union) | 5 year |
| Biochemical Markers | Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed. | 5 year |
| Serum Alkaline Phosphatase | Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed. | 5 years |
| Serum Creatinine |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria: participants with years since menopause less than 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weibo Xia, MD | Department of Endocrinology, Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
All participants who agreed to be re-evaluated were enrolled in this study.
In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Subjects | In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bone mineral density examination | Radiation | We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip. |
|
| Vertebral fracture assessment | Radiation | X-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique. |
|
| Biochemical markers analysis | Other | Fasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC). |
|
Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed. |
| 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fracture Group | Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
| BG001 | Non-fracture Group | Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Years since menopause | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Previous osteoporotic fracture | Number | participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Non-vertebral Fracture Incidence | Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975). | In 1100 participants, 975 of them finished the questionnaire | Posted | Number | participants | 5 year |
|
|
| |||||||||||||||||||||||||||||
| Primary | Vertebral Fracture Incidence | Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975) | Posted | Number | participants | 5 year |
|
| |||||||||||||||||||||||||||||||
| Primary | Bone Mineral Density | bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland) | Posted | Median | Inter-Quartile Range | g/cm^2 | 5 year |
|
| ||||||||||||||||||||||||||||||
| Primary | Bone Turnover Markers and 25(OH)D | C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union) | Posted | Median | Inter-Quartile Range | ng/ml | 5 year |
|
| ||||||||||||||||||||||||||||||
| Primary | Biochemical Markers | Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed. | Posted | Mean | Standard Deviation | mmol/L | 5 year |
|
| ||||||||||||||||||||||||||||||
| Primary | Serum Alkaline Phosphatase | Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed. | Posted | Mean | Standard Deviation | U/L | 5 years |
|
| ||||||||||||||||||||||||||||||
| Primary | Serum Creatinine | Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed. | Posted | Mean | Standard Error | umol/l | 5 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Subjects | In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture. | 0 | 975 | 0 | 975 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Weibo Xia | Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital,Chinese Academy of Medical Science | 86-10-6915-5076 | xiaweibo@medmail.com.cn |
| ID | Term |
|---|---|
| D058866 | Osteoporotic Fractures |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Male |
|
| No previous osteoporotic fracture |
|
|
|
|
|
|
|