Jogging in the Change of Osteoporosis
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
jogging
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Bone Diseases
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
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
NCT ID
NCT03359317
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
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
Learn more about this trial
Jogging in the Change of Osteoporosis
We'll reach out to this number within 24 hrs