Clinical trial NCT02142348: Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
Official title: Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Osteoporosis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomly selected two communities in Xuhui District to investigate.

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.

Eligibility 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.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: baseline
Secondary outcomes:
measure: SF-36
timeFrame: baseline
measure: international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST
timeFrame: baseline
measure: Markers of bone metabolism test
timeFrame: baseline
measure: EQ-5D
timeFrame: baseline
measure: Hepatic-renal function test
timeFrame: baseline
measure: thyroid stimulating hormone level test
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Study Principal Investigator Longhua Hospital
name: Yongjun Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: