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Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI)

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ClinicalTrials.gov Identifier: NCT02938923
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
University of Maryland, College Park
University of Colorado, Denver
The University of Texas Medical Branch, Galveston
Johns Hopkins University
Harvard University
University of Connecticut
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine

Brief Summary:
This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. One third of the participants will receive topical testosterone gel and a supervised exercise training program; one third will receive topical inactive gel and a supervised exercise training program; one third will receive a home exercise program. All participants will receive nutritional counseling, and calcium and vitamin D supplements.

Condition or disease Intervention/treatment Phase
Hip Fracture Frailty Sarcopenia Drug: Testosterone Drug: Placebo gel Behavioral: Supervised exercise training Behavioral: Home exercise program Behavioral: Health Education Modules Phase 3

Detailed Description:

Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. A clinically important functional decline and failure to recover following a hip fracture has been documented as late as a year after the fracture, even among women who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population, and showed gains in lean body mass (LBM) and muscle strength with active drug, compared to placebo. The benefits of exercise in restoring muscle strength and physical function after a hip fracture have been documented. However, it remains unclear whether T treatment can augment the effects of exercise on mobility and patient-reported function after hip fracture.

The STEP-HI study is a 3-group, multi-center, randomized, placebo-controlled, double-blinded, parallel group clinical trial in older female hip fracture patients. 300 female hip fracture patients, age 65 years and older, will be enrolled from 6 clinical sites, using objective screening criteria for T deficiency (serum total testosterone level < 40 ng/dL) and physical frailty (Modified Physical Performance Test (PPT) Score of 12-28). The trial will compare the effects of Enhanced Usual Care with home exercises and no gel treatment (EUC), supervised exercise training (EX) with inactive (placebo) gel (EX+P), and EX combined with T therapy (EX+T), to ascertain the incremental impact of adding T to EX in older adult women with a recent hip fracture. The study team will carefully monitor testosterone levels, adverse events, biochemical parameters, and factors related to adherence to the interventions.

Information from this study has the potential to alter treatment of hip fracture in older women, a problem that contributes to significant morbidity and mortality, and has a large public health impact. The STEP-HI study is highly aligned with NIA's mission of identifying interventions that target common geriatric conditions and improve treatment options for older adults with multiple morbidities or risk factors.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, investigators, and study staff conducting the interventions will be aware of the exercise group assignment. A Blinded Outcomes Assessor will be masked to study group assignment. Only the study pharmacist, an unblinded study physician, and Data Coordinating Center staff will be unblinded to gel treatment assignment.
Primary Purpose: Treatment
Official Title: Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise + Testosterone (EX + T)
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration.
Drug: Testosterone
Topical testosterone gel 1%
Other Name: T

Behavioral: Supervised exercise training
Multicomponent exercise program focused primarily on progressive resistance exercise training
Other Name: EX

Placebo Comparator: Exercise + Placebo (EX + P)
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Drug: Placebo gel
Inactive skin gel
Other Name: P

Behavioral: Supervised exercise training
Multicomponent exercise program focused primarily on progressive resistance exercise training
Other Name: EX

Enhanced Usual Care (EUC)
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Behavioral: Home exercise program
Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Other Name: EUC

Behavioral: Health Education Modules
30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
Other Name: EUC




Primary Outcome Measures :
  1. Change in six minute walk distance at 6 months [ Time Frame: Baseline and 6 months ]
    Distance that the individual can walk on a specified track, within six minutes


Secondary Outcome Measures :
  1. Change in Total Lean Body Mass at 6 months [ Time Frame: Baseline and 6 months ]
    Total lean body mass measured by dual x-ray absorptiometry (DXA)

  2. Change in Appendicular Lean Body Mass at 6 months [ Time Frame: Baseline and 6 months ]
    Lean body mass of the arms and legs, measures by dual x-ray absorptiometry (DXA)

  3. Change in 1-repetition maximum (1-RM) leg press strength at 6 months [ Time Frame: Baseline and 6 months ]
    1-repetition maximum strength for leg press

  4. Change in Total Modified Physical Performance Test (mPPT) Score at 6 months [ Time Frame: Baseline and 6 months ]
    9 objective physical performance tasks

  5. Change in Short Physical Performance Battery (SPPB) Score at 6 months [ Time Frame: Baseline and 6 months ]
    3 objective physical performance tasks (Chair rise, Progressive Romberg, Walking speed for an 8 ft course)

  6. Change in Older Adult Resources and Services Activities of Daily Living (ADL) Questionnaire (OARS) ADL Total Score at 6 months [ Time Frame: Baseline and 6 months ]
    Standardized self-report questions regarding performance of activities of daily living

  7. Change in Functional Status Questionnaire (FSQ) Total Score at 6 months [ Time Frame: Baseline and 6 months ]
    Standardized self-report questions regarding performance of activities of daily living

  8. Change in Hip Rating Questionnaire Total Score at 6 months [ Time Frame: Baseline and 6 months ]
    Standardized questions regarding quality of life and function as related to the hip fracture event

  9. Change in PROMIS Global Health score at 6 months [ Time Frame: Baseline and 6 months ]
    Standardized questions regarding quality of life

  10. Change in Bone Mineral Density (BMD) of the non-fractured proximal femur at 6 months [ Time Frame: Baseline and 6 months ]
    Bone mineral density measured by dual x-ray absorptiometry (DXA)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female 65 years and older.
  • Surgical repair of a non-pathologic fracture of the proximal femur (Including: intracapsular, intertrochanteric, and subtrochanteric fractures) with a surgical repair date that is within 6-14 weeks at screening, and within 16 weeks at randomization.
  • Community-dwelling or in assisted living prior to the hip fracture event.
  • Functional impairment at the time of screening, defined as a modified Physical Performance Score (mPPT) of 12-28.
  • Serum total testosterone level <40 ng/dL.

Exclusion Criteria:

  • Cognitive impairment or dementia of severity sufficient to interfere with ability to fully participate in the study or provide one's own informed consent, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration.
  • Residence too far from research center (specific distance to be determined by each site) or planned travel greater than 2 weeks within the next 9 months.
  • Anticipated to be permanently living in a nursing home at the time of randomization.
  • Use of progestin or androgen containing compound within the previous 6 months.
  • Treatment with systemic corticosteroids (daily dose > 5 mg prednisone or equivalent) for at least 90 days within the previous 12 months.
  • Visual or hearing impairments that interfere with following directions for research procedures.
  • Active or unstable cardiopulmonary disease (recent myocardial infarction, unstable angina, class III or IV Congestive Heart Failure) within prior 6 months, which would limit full participation in the study.
  • Respiratory disease requiring chronic continuous oxygen therapy, or oxygen therapy during walking or exercise, which would limit full participation in this study.
  • History of idiopathic deep venous thrombosis or pulmonary embolus (i.e., not related to period or immobilization or surgery), recurrent or multiple venous thrombi; history of a hypercoagulable state such as Factor V Leiden thrombophilia.
  • Musculoskeletal or neurological conditions that limit participation in this study, could be made worse by exercise training, or not expected to improve with exercise.
  • Lower extremity amputation other than toes.
  • Severe lower extremity pain or ulceration that could limit full participation in this study.
  • History of a hormone dependent neoplasia.
  • History of HIV or active viral hepatitis.
  • End Stage Renal Disease on dialysis or Glomerular Filtration Rate (GFR)<15 ml/min.
  • Allergy to gel components.
  • Recent history of alcohol or substance abuse, or current alcohol intake of ≥ 10 drinks/week.
  • Planned joint surgery during the intervention period.
  • Participation in another research study that in the site investigator's judgement could interfere or conflict with STEP-HI research assessments or interventions.
  • Current use of aldactone, flutamide or leflunomide.
  • Geriatric Depression Scale (GDS) score ≥ 12 at the screening assessment.
  • Uncontrolled hypertension, defined as a systolic BP > 160 mmHg or diastolic BP > 95 mmHg, on at least two occasions.
  • Elevated liver transaminase levels ≥ 2.5 times above normal range.
  • Erythrocytosis with hematocrit > 51% (all sites except UCD) or ≥ 52% at UCD.
  • Severe anemia defined as Hgb < 7gm/dL.
  • Uncontrolled diabetes defined as HgbA1C > 10%.
  • Untreated or unstable thyroid disease, with serum Thyriod-stimulating Hormone (TSH) level ≥ 10 milli-international units per liter (mIU/L) or TSH level ≤ 0.4 mIU/L.
  • Site investigator's judgement that the participant would not be able to complete research procedures or interventions.

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): NCT02938923


Contacts
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Contact: Ellen F Binder, MD 314-286-2707 ebinder@wustl.edu
Contact: Kelly M Monroe, MSW 314-273-1160 monroek@wustl.edu

Locations
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United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Study Coordinator    720-848-7333    STEP-HI@ucdenver.edu   
Contact: Kerry Hildreth, MD    303-724-1927      
Principal Investigator: Robert Schwartz, MD         
Sub-Investigator: Kerry Hildreth, MD         
United States, Connecticut
University of Connecticut Heath - UConn Health Recruiting
Farmington, Connecticut, United States, 06030
Contact: Heather McAbee-Sevick    806-679-6115    mcabeesevick@uchc.edu   
Principal Investigator: George Kuchel, MD         
Sub-Investigator: Richard Fortinsky, PhD         
Sub-Investigator: Jenna Bartley, PhD         
United States, Maryland
University of Maryland School of Medicine/Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Lynn Alford    410-706-5144    lalford@som.umaryland.edu   
Principal Investigator: Denise Orwig, PhD         
Sub-Investigator: Adrian Dobs, MD, MHS         
United States, Massachusetts
HebrewSenior Life Harvard Medical School Recruiting
Roslindale, Massachusetts, United States, 02131
Contact: Evelyn O'Neill    617-971-5347    oneill@hsl.harvard.edu   
Contact: Sarah Berry, MD    617-971-5355      
Principal Investigator: Douglas P. Kiel, MD         
Sub-Investigator: Sarah Berry, MD         
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Banach    314-273-0337    banachm@wustl.edu   
Principal Investigator: Ellen Binder, MD         
United States, Texas
University of Texas Medical Branch at Galveston (UTMB) Recruiting
Galveston, Texas, United States, 77555
Contact: Eloisa Martinez    409-266-9643    esmartin@utmb.edu   
Contact: Roxanna Hirst    409-266-9641    rmhirst@utmb.edu   
Principal Investigator: Elena Volpi, MD, PhD         
Sponsors and Collaborators
Washington University School of Medicine
University of Maryland, College Park
University of Colorado, Denver
The University of Texas Medical Branch, Galveston
Johns Hopkins University
Harvard University
University of Connecticut
Investigators
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Principal Investigator: Ellen F Binder, MD Washington University School of Medicine
Principal Investigator: Kenneth B Schechtman, PhD Washington University School of Medicine
Principal Investigator: Jay Magaziner, PhD University of Maryland, College Park

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Responsible Party: Ellen F. Binder, MD, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02938923     History of Changes
Other Study ID Numbers: R01AG051647 ( U.S. NIH Grant/Contract )
201609077 ( Other Identifier: Washington University HRPO )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sarcopenia
Frailty
Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Pathologic Processes
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents