Yoga in the Treatment of Osteoporosis

Osteoporosis Clinical Trial

Official title:

Yoga in the Treatment of Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399176
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: March 22, 2015
• Last updated: January 10, 2016
• Start date: January 2005
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Manhattan Physical Medicine and Rehabilitation, LLP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
United States	Manhattan Physical Medicine and Rehabilitation, LLP	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Physical Medicine and Rehabilitation, LLP	New York University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEXA T-score	Bone mineral density change in spine, hip and femur after 2 years of yoga.	2 years	No
Secondary	Change in bone quality after doing yoga for two years.		two years	No
Secondary	Number of fractures occurring while in study		two years	Yes

External Links

•   Helpful site to learn more and to sign up for study.