Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

Primary Osteoporosis Clinical Trial

Official title:

Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02142348
• Other study ID #: Shanghai OP Survey
• Status: Not yet recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 15, 2014
• Start date: June 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2014
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Xuejun Cui, Dr.
• Email: 13917715524[@]139.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Primary Osteoporosis

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		baseline	No
Secondary	SF-36	a composite of functional status	baseline	No
Secondary	international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST		baseline	No
Secondary	Markers of bone metabolism test	Fasting peripheral blood collected 2ml.Markers of bone metabolism test,including alkaline phosphatase, 25-hydroxy-vitamin D,prepeptide type? procollagen,osteocalcin,type I collagen cross-linked C-terminal telopeptide,tartrate resistant acid phosphatase.	baseline	No
Secondary	EQ-5D	A standardised instrument for use as a measure of health outcome.	baseline	No
Secondary	Hepatic-renal function test	Fasting peripheral blood collected 2ml.Hepatic-renal function test,including calcium, phosphorus, creatinine.	baseline	No
Secondary	thyroid stimulating hormone level test	Fasting peripheral blood collected 1ml for thyroid stimulating hormone test.	baseline	No