A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women

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.

Conditions

• Osteoporotic Fractures
• Osteoporosis, Postmenopausal

Interventions

OTHER

Questionaire survey

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.

RADIATION

Bone mineral density examination

We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip.

RADIATION

Vertebral fracture assessment

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.

OTHER

Biochemical markers analysis

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).

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Weibo Xia, MD · Department of Endocrinology, Peking Union Medical College Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

108 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2014-09-30

Completion

2016-05-31

Countries

• China

Study Locations