Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

• Conditions: Primary Osteoporosis

• Registration Number: NCT02142348
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

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 Timeline

• Status Verified: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Study First Posted: 2014-05-20
• Last Update Posted: 2014-05-20
• Study Start: 2014-06
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	baseline

Secondary Outcome Measures

Name	Time	Method
international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST	baseline
EQ-5D	baseline	A standardised instrument for use as a measure of health outcome.
Hepatic-renal function test	baseline	Fasting peripheral blood collected 2ml.Hepatic-renal function test，including calcium, phosphorus, creatinine.
SF-36	baseline	a composite of functional status
Markers of bone metabolism test	baseline	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.
thyroid stimulating hormone level test	baseline	Fasting peripheral blood collected 1ml for thyroid stimulating hormone test.

Trial Locations

Locations (1)

Longhua Hospital; 🇨🇳 Shanghai, Shanghai, China