Jogging in the Change of Osteoporosis

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

Study Overview

• Status: Unknown
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: jogging; At least 5 times/week	Behavioral: jogging; Jogging as instructed for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEXA T-score	Bone mineral density change in spine, hip and femur after 1 year of jogging	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of fractures	Number of fractures occurring while in study	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2018
• Primary Completion (Anticipated): January 30, 2019
• Study Completion (Anticipated): January 30, 2019

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Osteoporosis; Bone Diseases
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: PKUPH-JGO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No