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Trial record 4 of 1233 for:    "Osteoporosis"

Yoga in the Treatment of Osteoporosis

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ClinicalTrials.gov Identifier: NCT02399176
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
New York University
Information provided by (Responsible Party):
Loren M. Fishman,MD, Manhattan Physical Medicine and Rehabilitation, LLP

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
Osteoporosis Behavioral: Yoga Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga in the Treatment of Osteoporosis
Study Start Date : January 2005
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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 Name: Iyengar Yoga




Primary Outcome Measures :
  1. DEXA T-score [ Time Frame: 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. [ Time Frame: two years ]
  2. Number of fractures occurring while in study [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399176


Locations
United States, New York
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

Additional Information:
Publications of Results:
Fishman, LM. "Yoga for Osteoporosis - A pilot study." Topics in Geriatric Rehabilitation Vol. 25, No. 3, 2009 pp. 244-250.

Responsible Party: Loren M. Fishman,MD, Loren M. Fishman, MD, Manhattan Physical Medicine and Rehabilitation, LLP
ClinicalTrials.gov Identifier: NCT02399176     History of Changes
Other Study ID Numbers: 001
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Loren M. Fishman,MD, Manhattan Physical Medicine and Rehabilitation, LLP:
Osteoporosis
Yoga

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases