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SarcopeniaPhase 2NCT00183040

HORMA: Hormonal Regulators of Muscle and Metabolism in Aging

A Phase 2 study testing Topical testosterone and Recombinant human growth hormone in people with Sarcopenia and Muscle Weakness, run by National Institute on Aging (NIA) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the relationship of deficiencies in testosterone and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging and whether there is an interaction of these two hormone systems in maintaining normal skeletal muscle mass and physical function. Read more about this study

Who is it for?
Ages 65 to 90 years, men only
Conditions the study is for
Sarcopenia, Muscle Weakness, Frailty
What is being tested?
Topical testosterone and Recombinant human growth hormone
How many people
108 participants
Where
2 sitesUnited States
Study dates
Sep 2002to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Men who are 65-90 years of age
  • Total serum IGF-1 (insulin-like growth factor) in the lower tertile for adults (56-167 ug/dl)
  • Total serum testosterone of 150-550 ng/dL

Who cannot join

  • BMI (Body Mass Index) 35 kg/m2 or greater
  • Weight instability (>3% change in prior 3 months)
  • Daily intake of total kilocalories less than or equal to 0.8X the RDA and intake of protein between 0.8 and 1.4 g/kg/day inclusive
  • Acute illness in the prior 30 days
  • Resistance training (wt lifting) in the past 12 months
  • Vigorous aerobic sports (Competing as a Master athlete in the prior 5 years; weekly swimming, racquet ball, cycling, tennis, in preceding 12 months)
Show all 24Show fewer
  • Use of an anabolic agent (androgen, androgen precursor, rhGH, etc) in the preceding 12 months
  • Use of medications that might affect amino acid metabolism (e.g. beta-adrenergic blockers, beta-agonists, Ca2+ channel blockers, corticosteroids)
  • Fasting sugar greater than or equal to 126 mg/dl or diabetes requiring Rx
  • History of benign intracranial hypertension
  • Heart failure, active angina, or myocardial infarction in the prior 6 months or history of aortic stenosis
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Rheumatoid arthritis, cirrhosis or active hepatitis
  • History of carpal tunnel syndrome
  • Prior cancer other than squamous or basal cell carcinoma of the skin
  • Sleep apnea or severe chronic lung disease
  • Anticoagulation with heparin or coumadin
  • Blood pressure not controlled with medication to <180/95 mm Hg
  • Calculated creatinine clearance <50 cc/min
  • Serum prostatic antigen >4.0 or American Urological Association score greater than or equal to 8
  • Hematocrit greater than or equal 52%, or ALT >1.5X ULN
  • Failure to pass a modified Bruce treadmill stress test
  • Severe disability limiting strength or physical function testing
  • Dementia or cognitive impairment affecting a subject's ability to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Tufts University

    Boston, Massachusetts, 02111

  • Washington University School of Medicine

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Hormonal Regulators of Muscle and Metabolism in Aging

The purpose of this study is to determine the relationship of deficiencies in testosterone and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging and whether there is an interaction of these two hormone systems in maintaining normal skeletal muscle mass and physical function.

Read the detailed description

Elderly persons experience progressive loss of skeletal muscle mass, muscle strength, and functional capacity for activities of daily living. Aging is also associated with a loss of hormones believed to be related to muscle and strength, namely testosterone and growth hormone (GH). The hypothesis being tested is that both hormone systems regulate musculoskeletal protein mass and contractile fibers by different and complimentary mechanisms and that optimal levels of both testosterone and GH are necessary to maintain skeletal muscle mass, muscular strength and power, and full functional activities of daily living during the aging process.

This is a controlled, 16 week study to evaluate the independent effects and interaction of these two anabolic hormone systems in community dwelling elderly men 65-90 years of age who are hyposomatotropic (deficiency of growth hormone) with low eugonadal status (total testosterone of 150-550 ng/dL). The study will utilize a two tiered randomization in which 108 study participants will first be randomized to either the low or high eugonadal level of testosterone using a novel Leydig cell clamp method (GnRH (gonadotropin-releasing hormone) agonist plus topical testosterone supplementation) to achieve target levels of testosterone. Low gonadal status (150-550 ng/dL) will be maintained with 5 g daily doses of topical testosterone, whereas high gonadal status (650-950 ng/dL) will be achieved with 10 g daily doses. Within these two groups, participants will be randomized to receive placebo or one of two doses of rhGH (recombinant human growth hormone) therapy (0, 3.0, 5.0 mcg/kg/day) in a double blinded fashion.

Being tested
Topical testosterone, Recombinant human growth hormone
Keywords
andropause, hormone therapy, HRT
Medical subject headings
Sarcopenia, Muscle Weakness, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical testosteroneDrug

  • Recombinant human growth hormoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measures of fractional synthetic rates of mixed and contractile (actin and myosin heavy chain [MHC]) skeletal muscle proteins and degradation of skeletal muscle (ubiquitin, and proteasome sub-units)

  2. analysis of local regulators of skeletal muscle synthesis (e.g. IGF-1, IGFBP4, myostatin).

Secondary outcomes (1)

  1. change in skeletal muscle strength, muscle mass, power and fatigability (endurance), physical performance, and markers of safety.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startSep 2002
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183040
Sponsor's protocol ID
AG0045
Other IDs
R01AG018169-01, USC GCRC Protocol #1030
Status last verified
May 2009
First submitted
13 Sep 2005
Last updated
2 Jun 2009
Results posted
No

Publications

  • Dutta C, Hadley EC, Lexell J. Sarcopenia and physical performance in old age: overview. Muscle Nerve Suppl. 1997;5:S5-9. No abstract available.

    PubMed 9331374

  • Hasten DL, Pak-Loduca J, Obert KA, Yarasheski KE. Resistance exercise acutely increases MHC and mixed muscle protein synthesis rates in 78-84 and 23-32 yr olds. Am J Physiol Endocrinol Metab. 2000 Apr;278(4):E620-6. doi: 10.1152/ajpendo.2000.278.4.E620.

    PubMed 10751194

  • Urban RJ, Bodenburg YH, Gilkison C, Foxworth J, Coggan AR, Wolfe RR, Ferrando A. Testosterone administration to elderly men increases skeletal muscle strength and protein synthesis. Am J Physiol. 1995 Nov;269(5 Pt 1):E820-6. doi: 10.1152/ajpendo.1995.269.5.E820.

    PubMed 7491931

  • Ferrando AA, Sheffield-Moore M, Yeckel CW, Gilkison C, Jiang J, Achacosa A, Lieberman SA, Tipton K, Wolfe RR, Urban RJ. Testosterone administration to older men improves muscle function: molecular and physiological mechanisms. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E601-7. doi: 10.1152/ajpendo.00362.2001.

    PubMed 11832363

  • Blackman MR, Sorkin JD, Munzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, Jayme J, O'Connor KG, Christmas C, Tobin JD, Stewart KJ, Cottrell E, St Clair C, Pabst KM, Harman SM. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2282-92. doi: 10.1001/jama.288.18.2282.

    PubMed 12425705

  • Yarasheski KE, Castaneda-Sceppa C, He J, Kawakubo M, Bhasin S, Binder EF, Schroeder ET, Roubenoff R, Azen SP, Sattler FR. Whole-body and muscle protein metabolism are not affected by acute deviations from habitual protein intake in older men: the Hormonal Regulators of Muscle and Metabolism in Aging (HORMA) Study. Am J Clin Nutr. 2011 Jul;94(1):172-81. doi: 10.3945/ajcn.110.010959. Epub 2011 May 4.

    PubMed 21543538

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical testosterone and Recombinant human growth hormone in people with Sarcopenia and Muscle Weakness, run by National Institute on Aging (NIA) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measures of fractional synthetic rates of mixed and contractile (actin and myosin heavy chain [MHC]) skeletal muscle proteins and degradation of skeletal muscle (ubiquitin, and proteasome sub-units). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00183040, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2009.

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Clinical Trial NCT00183040 | AzTrials