Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02142348

Enrollment

3000

Registered

2014-05-20

Start date

2014-06-30

Completion date

2018-12-31

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Osteoporosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density	baseline

Secondary

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

Countries

China

Contacts

Primary ContactXuejun Cui, Dr.

13917715524@139.com

Outcome results