Effects of DHEA/Exercise on Bone, Muscle and Balance

NCT00664053 | Completed Phase 4

• 2 other identifiers: AG0099NNG04GK63G
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Frailty

Keywords

bone mineral density; bone turnover markers; strength; balance

Outcome Measures

Primary Outcomes (1)

• Muscle strength, bone turnover markers

  baseline, 3 month and 6 months

Secondary Outcomes (2)

• Changes in activities of daily living, cognitive and emotional function

  baseline and 6 months

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

  baseline and 6 months

Study Arms (4)

1

EXPERIMENTAL

DHEA and Yoga

Dietary Supplement: DHEA; Behavioral: Yoga

2

ACTIVE COMPARATOR

DHEA and exercise

Dietary Supplement: DHEA; Behavioral: Aerobics

3

ACTIVE COMPARATOR

Placebo and Yoga

Behavioral: Yoga; Dietary Supplement: Placebo

4

PLACEBO COMPARATOR

Placebo and exercise

Dietary Supplement: Placebo; Behavioral: Aerobics

Interventions

DHEA DIETARY_SUPPLEMENT

50mg daily for 6 months

Also known as: Dehydroepiandrosterone

1; 2

Yoga BEHAVIORAL

2 sessions per week for 6 months

1; 3

Placebo DIETARY_SUPPLEMENT

Placebo supplement every day for 6 months

3; 4

Aerobics BEHAVIORAL

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

2; 4

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead
• University of Connecticut: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-5215, United States

Location

Related Publications (4)

• 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.

  PMID: 18084691 BACKGROUND

• 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.

  PMID: 16549048 BACKGROUND

• 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.

  PMID: 12356608 BACKGROUND

• 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.

  PMID: 20863330 DERIVED

MeSH Terms

Conditions

Osteoporosis; Frailty

Interventions

Dehydroepiandrosterone; Yoga; Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne Kenny, MD

  University of Connecticut Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: October 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 29, 2008

Record last verified: 2008-04

Locations

US (1)