Trial Outcomes & Findings for A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women (NCT NCT02247011)
NCT ID: NCT02247011
Last Updated: 2016-09-30
Results Overview
Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1100 participants
Primary outcome timeframe
5 year
Results posted on
2016-09-30
Participant Flow
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.
All participants who agreed to be re-evaluated were enrolled in this study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1100
|
|
Overall Study
COMPLETED
|
975
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Poor quality of radiological results
|
125
|
Baseline Characteristics
A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
Total
n=975 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
70.08 years
n=5 Participants
|
66.09 years
n=7 Participants
|
66.72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
864 Participants
n=7 Participants
|
975 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Years since menopause
|
21.36 years
n=5 Participants
|
16.43 years
n=7 Participants
|
16.92 years
n=5 Participants
|
|
Previous osteoporotic fracture
Previous osteoporotic fracture
|
72 participants
n=5 Participants
|
288 participants
n=7 Participants
|
360 participants
n=5 Participants
|
|
Previous osteoporotic fracture
No previous osteoporotic fracture
|
39 participants
n=5 Participants
|
576 participants
n=7 Participants
|
615 participants
n=5 Participants
|
|
Body mass index
|
25.21 kg/m^2
STANDARD_DEVIATION 5.04 • n=5 Participants
|
25.47 kg/m^2
STANDARD_DEVIATION 4.85 • n=7 Participants
|
25.46 kg/m^2
STANDARD_DEVIATION 4.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearPopulation: In 1100 participants, 975 of them finished the questionnaire
Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Non-vertebral Fracture Incidence
|
70 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 5 yearVertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Vertebral Fracture Incidence
|
51 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 5 yearbone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
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|---|---|---|
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Bone Mineral Density
Lumbar spine BMD
|
0.907 g/cm^2
Interval 0.784 to 1.015
|
0.956 g/cm^2
Interval 0.837 to 1.086
|
|
Bone Mineral Density
Femoral neck BMD
|
0.686 g/cm^2
Interval 0.611 to 0.755
|
0.732 g/cm^2
Interval 0.647 to 0.82
|
|
Bone Mineral Density
Total hip BMD
|
0.788 g/cm^2
Interval 0.736 to 0.845
|
0.845 g/cm^2
Interval 0.76 to 0.936
|
PRIMARY outcome
Timeframe: 5 yearC-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)
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Bone Turnover Markers and 25(OH)D
β-CTX
|
0.437 ng/ml
Interval 0.309 to 0.529
|
0.401 ng/ml
Interval 0.285 to 0.54
|
|
Bone Turnover Markers and 25(OH)D
P1NP
|
51.88 ng/ml
Interval 41.4 to 70.16
|
51.57 ng/ml
Interval 39.76 to 67.82
|
|
Bone Turnover Markers and 25(OH)D
25(OH)D
|
13.21 ng/ml
Interval 10.0 to 17.43
|
12.49 ng/ml
Interval 9.25 to 16.31
|
PRIMARY outcome
Timeframe: 5 yearFasting 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.
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Biochemical Markers
Serum calcium
|
2.302 mmol/L
Standard Deviation 0.565
|
2.263 mmol/L
Standard Deviation 0.625
|
|
Biochemical Markers
Serum phosphate
|
1.148 mmol/L
Standard Deviation 0.220
|
1.122 mmol/L
Standard Deviation 0.345
|
|
Biochemical Markers
Serum glucose
|
6.083 mmol/L
Standard Deviation 1.810
|
6.112 mmol/L
Standard Deviation 1.281
|
PRIMARY outcome
Timeframe: 5 yearsFasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Serum Alkaline Phosphatase
|
79.4 U/L
Standard Deviation 33.0
|
77.5 U/L
Standard Deviation 37.0
|
PRIMARY outcome
Timeframe: 5 yearsFasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.
Outcome measures
| Measure |
Fracture Group
n=111 Participants
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
n=864 Participants
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.
|
|---|---|---|
|
Serum Creatinine
|
62.77 umol/l
Standard Error 17.73
|
64.91 umol/l
Standard Error 14.59
|
Adverse Events
Overall Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Weibo Xia
Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital,Chinese Academy of Medical Science
Phone: 86-10-6915-5076
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place