Back to results

Effects of DHEA/Exercise on Bone, Muscle and Balance

Primary Purpose

Osteoporosis, Frailty

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

DHEA

Yoga

Placebo

Aerobics

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring bone mineral density, bone turnover markers, strength, balance

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women over age 65 years
Bone mineral density t-score less than -1
At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
DHEAS levels less than 550 ng/dl
Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
Mammogram within the preceding 12 months

Exclusion Criteria:

Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
Use of androgen or estrogen in the preceding year
Use of psychiatric medications including antipsychotic medications and SSRI
Metastatic or advanced cancer (other than skin cancer)
History of breast cancer
Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months

Sites / Locations

University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

DHEA and Yoga

DHEA and exercise

Placebo and Yoga

Placebo and exercise

Outcomes

Primary Outcome Measures

Muscle strength, bone turnover markers

Secondary Outcome Measures

Changes in activities of daily living, cognitive and emotional function

Laboratory tests to measure factors that may reflect or influence changes in bone metabolism

Full Information

NCT ID

NCT00664053

First Posted

April 18, 2008

Last Updated

April 25, 2008

Sponsor

National Aeronautics and Space Administration (NASA)

Collaborators

University of Connecticut

1. Study Identification

Unique Protocol Identification Number

NCT00664053

Brief Title

Effects of DHEA/Exercise on Bone, Muscle and Balance

Official Title

Effects of DHEA/Exercise on Bone, Muscle and Balance

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Aeronautics and Space Administration (NASA)

Collaborators

University of Connecticut

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.

Detailed Description

Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response. The specific aims of this study are: To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Frailty

Keywords

bone mineral density, bone turnover markers, strength, balance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

DHEA and Yoga

Arm Title

Arm Type

Active Comparator

Arm Description

DHEA and exercise

Arm Title

Arm Type

Active Comparator

Arm Description

Placebo and Yoga

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo and exercise

Intervention Type

Dietary Supplement

Intervention Name(s)

DHEA

Other Intervention Name(s)

Dehydroepiandrosterone

Intervention Description

50mg daily for 6 months

Intervention Type

Behavioral

Intervention Name(s)

Yoga

Intervention Description

2 sessions per week for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo supplement every day for 6 months

Intervention Type

Behavioral

Intervention Name(s)

Aerobics

Intervention Description

Walking/chair aerobics program 2 sessions per week for 6 months

Primary Outcome Measure Information:

Title

Muscle strength, bone turnover markers

Time Frame

baseline, 3 month and 6 months

Secondary Outcome Measure Information:

Title

Changes in activities of daily living, cognitive and emotional function

Time Frame

baseline and 6 months

Title

Laboratory tests to measure factors that may reflect or influence changes in bone metabolism

Time Frame

baseline and 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women over age 65 years Bone mineral density t-score less than -1 At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion) DHEAS levels less than 550 ng/dl Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits Mammogram within the preceding 12 months Exclusion Criteria: Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH) Use of androgen or estrogen in the preceding year Use of psychiatric medications including antipsychotic medications and SSRI Metastatic or advanced cancer (other than skin cancer) History of breast cancer Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Kenny, MD

Organizational Affiliation

University of Connecticut Center on Aging

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030-5215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18084691

Citation

von Muhlen D, Laughlin GA, Kritz-Silverstein D, Bergstrom J, Bettencourt R. Effect of dehydroepiandrosterone supplementation on bone mineral density, bone markers, and body composition in older adults: the DAWN trial. Osteoporos Int. 2008 May;19(5):699-707. doi: 10.1007/s00198-007-0520-z. Epub 2007 Dec 15.

Results Reference

background

PubMed Identifier

16549048

Citation

Wang YD, Wang L, Li DJ, Wang WJ. Dehydroepiandrosterone inhibited the bone resorption through the upregulation of OPG/RANKL. Cell Mol Immunol. 2006 Feb;3(1):41-5.

Results Reference

background

PubMed Identifier

12356608

Citation

Greendale GA, McDivit A, Carpenter A, Seeger L, Huang MH. Yoga for women with hyperkyphosis: results of a pilot study. Am J Public Health. 2002 Oct;92(10):1611-4. doi: 10.2105/ajph.92.10.1611. No abstract available.

Results Reference

background

PubMed Identifier

20863330

Citation

Kenny AM, Boxer RS, Kleppinger A, Brindisi J, Feinn R, Burleson JA. Dehydroepiandrosterone combined with exercise improves muscle strength and physical function in frail older women. J Am Geriatr Soc. 2010 Sep;58(9):1707-14. doi: 10.1111/j.1532-5415.2010.03019.x.

Results Reference

derived

Learn more about this trial

Effects of DHEA/Exercise on Bone, Muscle and Balance

We'll reach out to this number within 24 hrs