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Jogging in the Change of Osteoporosis

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
jogging
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Bone Diseases

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    jogging

    Arm Description

    At least 5 times/week

    Outcomes

    Primary Outcome Measures

    DEXA T-score
    Bone mineral density change in spine, hip and femur after 1 year of jogging

    Secondary Outcome Measures

    Number of fractures
    Number of fractures occurring while in study

    Full Information

    First Posted
    November 26, 2017
    Last Updated
    November 29, 2017
    Sponsor
    Peking University People's Hospital
    Collaborators
    Shenzhen Sun Yat-sen Cardiovascular Hospital, Wujin People's Hospital, Chongqing Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03359317
    Brief Title
    Jogging in the Change of Osteoporosis
    Official Title
    Jogging in the Change of Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 20, 2018 (Anticipated)
    Primary Completion Date
    January 30, 2019 (Anticipated)
    Study Completion Date
    January 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital
    Collaborators
    Shenzhen Sun Yat-sen Cardiovascular Hospital, Wujin People's Hospital, Chongqing Zhongshan Hospital

    4. Oversight

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

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    Osteoporosis, Bone Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    jogging
    Arm Type
    Experimental
    Arm Description
    At least 5 times/week
    Intervention Type
    Behavioral
    Intervention Name(s)
    jogging
    Intervention Description
    Jogging as instructed for 1 year
    Primary Outcome Measure Information:
    Title
    DEXA T-score
    Description
    Bone mineral density change in spine, hip and femur after 1 year of jogging
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Number of fractures
    Description
    Number of fractures occurring while in study
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peixun Zhang, MD
    Phone
    15210802766
    Email
    875274428@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peixun Zhang, MD
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Jogging in the Change of Osteoporosis

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