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Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142348
Recruitment Status : Unknown
Verified May 2014 by Cui xuejun, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Cui xuejun, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort
osteoprosis research



Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. SF-36 [ Time Frame: baseline ]
    a composite of functional status

  2. international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST [ Time Frame: baseline ]
  3. Markers of bone metabolism test [ Time Frame: 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.

  4. EQ-5D [ Time Frame: baseline ]
    A standardised instrument for use as a measure of health outcome.

  5. Hepatic-renal function test [ Time Frame: baseline ]
    Fasting peripheral blood collected 2ml.Hepatic-renal function test,including calcium, phosphorus, creatinine.

  6. thyroid stimulating hormone level test [ Time Frame: baseline ]
    Fasting peripheral blood collected 1ml for thyroid stimulating hormone test.


Biospecimen Retention:   Samples With DNA
Basal whole blood is collected for serum and DNA extraction.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Randomly selected two communities in Xuhui District to investigate.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142348


Contacts
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Contact: Xuejun Cui, Dr. 13917715524@139.com

Locations
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China, Shanghai
Longhua Hospital
Shanghai, Shanghai, China, 200032
Contact: Xuejun Cui       13917715524@139.com   
Principal Investigator: Chenguang Li, Dr.         
Principal Investigator: Jing Wang, master         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yongjun Wang, Dr Study Principal Investigator Longhua Hospital
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Responsible Party: Cui xuejun, Vice director, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02142348    
Other Study ID Numbers: Shanghai OP Survey
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases