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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 5-Year Long-term Follow-up Study of a Cross-Sectional Cohort Study (PK-VF) For the Examination of the Association of Vitamin D/Bone Turnover/Bone Mineral Density With an Incident Fracture in Chinese

Brief 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.

Detailed Summary:

  1. In 2013, 5 years after PK-VF, the same 2070 subjects were contacted by the original sites. Among them 1242 subjects were able to come for the follow-up assessment.
  2. Clinical assessments: The participant's bio-information, physical examination and medical history were collected;Questionnaire including social/life style and medical evaluations (years since menopause (YSM), fracture history, milk/yoghourt/coffee/wine intake, calcium intake, or smoking history) were collected by PK-VF investigators. Non-vertebral fracture history evaluation: specific non-vertebral fracture sites include rib or clavicle, forearm, upper arm, hand (including wrist), pelvis, hip, thigh (not including hip), leg, and foot (including ankle). When non-vertebral fractures are suspected, questions were raised to the participant to eliminate possible biases (How did you get these fractures, a slight fall at home, fell from a high place, hit by someone, broken during a car accident or an operation? Did you see a doctor to confirm these fractures?) A fracture occurred in regular daily activities or due to mild trauma was defined as fragile non-vertebral fracture.
  3. Biochemical measurements: Fasting blood sample (~5 ml) was collected from each participant at participating sites; In 2007-2008 study, blood samples were collected during April-July, while in the 5-year follow-up; samples were collected in the same period of time. C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25 (OH) D will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union); Chemistry including alkaline phosphatase (ALP), calcium (Ca), creatinine (Cr), and glucose, will be measured by using automated techniques in the institute (Peking
    Sponsor: Peking Union Medical College Hospital

    Current Primary Outcome:

    • Non-vertebral Fracture Incidence [ Time Frame: 5 year ]
      Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
    • Vertebral Fracture Incidence [ Time Frame: 5 year ]
      Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)
    • Bone Mineral Density [ Time Frame: 5 year ]
      bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)
    • Bone Turnover Markers and 25(OH)D [ Time Frame: 5 year ]
      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)
    • Biochemical Markers [ Time Frame: 5 year ]
      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.
    • Serum Alkaline Phosphatase [ Time Frame: 5 years ]
      Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.


      • Original Primary Outcome:

      • Non-vertebral Fracture Incidence [ Time Frame: 5 year ]
        non-vertbral fractures were assessed by questionnaire survey
      • Vertebral Fracture Incidence [ Time Frame: 5 year ]
        vertebral fractures were assessed by lateral radiograph
      • Bone Mineral Density [ Time Frame: 5 year ]
        bone mineral density of Lumbar spine and femoral neck were measured by DXA (Lunar DPX or Norland)
      • Bone Turnover Markers and 25(OH)D [ Time Frame: 5 year ]
        β-CTX, P1NP, and 25 (OH) D will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)
      • biochemical markers [ Time Frame: 5 years ]
        Chemistry including ALP, Ca, Cr, and glucose, will be measured by using automated techniques in the institute (Peking Union)


      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Peking Union Medical College Hospital

      Dates:
      Date Received: September 19, 2014
      Date Started: March 2013
      Date Completion:
      Last Updated: August 8, 2016
      Last Verified: August 2016