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Yoga in the Treatment of Osteoporosis

Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP (Other)
Overall Status
Completed
CT.gov ID
NCT02399176
Collaborator
New York University (Other)
741
Enrollment
1
Location
1
Arm
128
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
741 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Yoga in the Treatment of Osteoporosis
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yoga of minimal intensity

Does Yoga: At least 4 times/week.

Behavioral: Yoga
Subjects assume 10 physical postures for 30 seconds each
Other Names:
  • Iyengar Yoga

    		•

    Outcome Measures

    Primary Outcome Measures

    1. DEXA T-score [2 years]

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

    Secondary Outcome Measures

    1. Change in bone quality after doing yoga for two years. [two years]

    2. Number of fractures occurring while in study [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manhattan Physical Medicine and Rehabilitation, LLP New York New York United States 10028

    Sponsors and Collaborators

    • Manhattan Physical Medicine and Rehabilitation, LLP
    • New York University

    Investigators

    • Principal Investigator: Loren M Fishman, MD, Manhattan Physical Medicine and Rehabilitation, LLP

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Loren M. Fishman,MD, Loren M. Fishman, MD, Manhattan Physical Medicine and Rehabilitation, LLP
    ClinicalTrials.gov Identifier:
    NCT02399176
    Other Study ID Numbers:
    • 001
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    Jan 12, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Loren M. Fishman,MD, Loren M. Fishman, MD, Manhattan Physical Medicine and Rehabilitation, LLP
    Osteoporosis
    Yoga
    Additional relevant MeSH terms:
    Osteoporosis

    Study Results

    No Results Posted as of Jan 12, 2016