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Yoga in the Treatment of Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Manhattan Physical Medicine and Rehabilitation, LLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older 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.

Sites / Locations

  • Manhattan Physical Medicine and Rehabilitation, LLP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga of minimal intensity

Arm Description

Does Yoga: At least 4 times/week.

Outcomes

Primary Outcome Measures

DEXA T-score
Bone mineral density change in spine, hip and femur after 2 years of yoga.

Secondary Outcome Measures

Change in bone quality after doing yoga for two years.
Number of fractures occurring while in study

Full Information

First Posted
March 22, 2015
Last Updated
January 10, 2016
Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
Collaborators
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT02399176
Brief Title
Yoga in the Treatment of Osteoporosis
Official Title
Yoga in the Treatment of Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
Collaborators
New York University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study measures change in bone mineral density by the DEXA scan before and two or more years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips and femur.
Detailed Description
After collecting blood and urine samples, and pre-study DEXA scans, qualifying patients are given an entry DEXA scan and a DVD with instructions to advance from beginner versions of 12 Iyengar-style yoga poses to more advanced levels in daily practice for 2 years. fter two years or more, 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 with an on line scorecard, supplemented by emails and/or telephone calls when judged necessary by the PI. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan, changes in osteoarthritis according to the X-rays, and changes in bone quality before and two or more years after beginning the ten minutes of daily yoga. Dose-response relationships between the amount and intensity of yoga practice and bone mineral density and quality are sought. Yoga-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, Yoga

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Yoga of minimal intensity
Arm Type
Experimental
Arm Description
Does Yoga: At least 4 times/week.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Other Intervention Name(s)
Iyengar Yoga
Intervention Description
Subjects assume 10 physical postures for 30 seconds each
Primary Outcome Measure Information:
Title
DEXA T-score
Description
Bone mineral density change in spine, hip and femur after 2 years of yoga.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in bone quality after doing yoga for two years.
Time Frame
two years
Title
Number of fractures occurring while in study
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren M Fishman, MD
Organizational Affiliation
Manhattan Physical Medicine and Rehabilitation, LLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Physical Medicine and Rehabilitation, LLP
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Fishman, LM. "Yoga for Osteoporosis - A pilot study." Topics in Geriatric Rehabilitation Vol. 25, No. 3, 2009 pp. 244-250.
Results Reference
result
Links:
URL
http://sciatica.org
Description
Helpful site to learn more and to sign up for study.

Learn more about this trial

Yoga in the Treatment of Osteoporosis

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