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Jogging in the Change of Osteoporosis

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ClinicalTrials.gov Identifier: NCT03359317
Recruitment Status : Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
Shenzhen Sun Yat-sen Cardiovascular Hospital
Wujin People's Hospital
Chongqing Zhongshan Hospital
Information provided by (Responsible Party):
Zhang Yichong, Peking University People's Hospital

Brief Summary:
To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging

Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: jogging Not Applicable

Detailed Description:
Patients in this research are given an entry Bone Densitometry(DEXA)scan and are required to advance from 3-minute jogging a day to 10-minute level in daily practice for 1 year as instructed. After 1 year, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan in the study. Dose-response relationships between the amount of jogging and bone mineral density are sought. Jogging-related fractures and other adverse effects are also noted.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Jogging in the Change of Osteoporosis
Estimated Study Start Date : February 20, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: jogging
At least 5 times/week
Behavioral: jogging
Jogging as instructed for 1 year



Primary Outcome Measures :
  1. DEXA T-score [ Time Frame: 1 year ]
    Bone mineral density change in spine, hip and femur after 1 year of jogging


Secondary Outcome Measures :
  1. Number of fractures [ Time Frame: 1 year ]
    Number of fractures occurring while in study



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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX

Exclusion Criteria:

Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs, severe heart disease


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): NCT03359317


Contacts
Contact: Peixun Zhang, MD 15210802766 875274428@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
Wujin People's Hospital
Chongqing Zhongshan Hospital
Investigators
Principal Investigator: Peixun Zhang, MD Peking University People's Hospital

Responsible Party: Zhang Yichong, Department of orthopaedics and trauma, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03359317     History of Changes
Other Study ID Numbers: PKUPH-JGO
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhang Yichong, Peking University People's Hospital:
Osteoporosis
Bone Diseases

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases