N/A
Completed N=1,100
A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women
Osteoporotic fractures · Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT02247011 ↗
Enrolled (actual)
1,100
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Non-vertebral Fracture Incidence — 70; 0 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-vertebral Fracture Incidence |
70; 0 | — |
| PRIMARY Vertebral Fracture Incidence |
51; 0 | — |
| PRIMARY Bone Mineral Density |
0.907; 0.956; 0.686; 0.732; 0.788; 0.845 | — |
| PRIMARY Bone Turnover Markers and 25(OH)D |
0.437; 0.401; 51.88; 51.57; 13.21; 12.49 | — |
| PRIMARY Biochemical Markers |
2.302; 2.263; 1.148; 1.122; 6.083; 6.112 | — |
| PRIMARY Serum Alkaline Phosphatase |
79.4; 77.5 | — |
| PRIMARY Serum Creatinine |
62.77; 64.91 | — |
Eligibility Criteria
Inclusion Criteria
- postmenopausal women (normally over 50 years old and years since menopause over than 1 year) in Peking.
- participants without any fracture in 2007 PK-VF study were included in the prospective study investigating the association of bone turnover markers/BMD/25(OH)D with fracture incidence.
Exclusion Criteria: participants with years since menopause less than 1 year.
Data sourced from ClinicalTrials.gov (NCT02247011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.