Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents.

Study Overview

• Status: Unknown
• Conditions: Primary Osteoporosis

Detailed Description

1. Objective:

   • To popularize knowledge of prevention and health care of osteoporosis.
   • To investigate the prevalence of primary osteoporosis in community residents.

2. Method:

   • The survey study included the five boroughs of six communities in Shanghai (Xuhui District 2, Pudong New Area 1, Minhang District 1, Pudong New Area 1, Jiading District 1). 10,000 participants are expected to be included.
   • Through a questionnaire and physical examination form, carries on the investigation to the 50-85 years old postmenopausal women during the 3-year follow-up period.
   • Make a survey of Bone Mineral Density,SF-36,international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST,Markers of bone metabolism test,EQ-5D,Hepatic-renal function test and thyroid stimulating hormone level test.
   • Physicians in each community as the backbone, Shanghai University of Traditional Chinese Medicine, Longhua Hospital is responsible for personnel training.
   • Shanghai Clinical Research Center is responsible for program and data management.
   • Shanghai District Health and Family Planning Commission is responsible for coordinating the organization.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Xuejun Cui, Dr.; Email: 13917715524@139.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital
      • Contact: Xuejun Cui; Email: 13917715524@139.com
      • Principal Investigator: Chenguang Li, Dr.
      • Principal Investigator: Jing Wang, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Randomly selected two communities in Xuhui District to investigate.

Description

Inclusion Criteria:

• Had clinical diagnosis of osteoporosis.
• With Bone Mineral Density by dual energy X-ray examination, T value <-2.5 or less.
• Be willing to and be able to join in the study and signed Informed consent.

Exclusion Criteria:

• Excluding the impact of endocrine diseases of bone metabolism (gonadal, adrenal, parathyroid and thyroid disease), rheumatoid arthritis and other autoimmune diseases that affect the absorption of calcium and vitamin D and regulation of the digestive tract and kidney disease, multiple myeloma and other malignant diseases, long-term use of corticosteroids or other drugs affecting bone metabolism, and a variety of congenital and acquired diseases of bone metabolism.
• if they were unable to complete the study survey.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
osteoprosis research

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone Mineral Density	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	a composite of functional status	baseline
international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST		baseline
Markers of bone metabolism test	Fasting peripheral blood collected 2ml.Markers of bone metabolism test，including alkaline phosphatase, 25-hydroxy-vitamin D，prepeptide typeⅠ procollagen，osteocalcin，type I collagen cross-linked C-terminal telopeptide，tartrate resistant acid phosphatase.	baseline
EQ-5D	A standardised instrument for use as a measure of health outcome.	baseline
Hepatic-renal function test	Fasting peripheral blood collected 2ml.Hepatic-renal function test，including calcium, phosphorus, creatinine.	baseline
thyroid stimulating hormone level test	Fasting peripheral blood collected 1ml for thyroid stimulating hormone test.	baseline

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Yongjun Wang, Dr, Study Principal Investigator Longhua Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Shanghai OP Survey