AgingPhase 4NCT00182871
Testosterone Effects on Bone and Frailty
A Phase 4 study testing testosterone in people with Aging and Frailty, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of testosterone replacement on bone density, muscle strength, physical performance, quality of life and prostate symptoms in men selected for low bone mineral density or fracture and some aspect of frailty. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Aging, Frailty, Osteoporosis
- What is being tested?
- testosterone
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jul 2007
- Phase
- Phase 4
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men over age 60 years who have sustained a femoral fracture in the preceding 3 years
- Total testosterone levels below 375 ng/dl or bioavailable testosterone levels at least 1.5 SD lower than the young adult mean
- Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
Who cannot join
- Prostate specific antigen level over 4.0 ng/dl or the history of prostate cancer
- Disease of bone metabolism (i.e., Paget's disease, osteomalacia, hyperparathyroidism)
- History of pituitary disease
- History of sleep apnea
- Consumption of more than 3 alcoholic drinks/day
- Use of androgen, estrogen, or DHEA in the preceding year
Show all 13Show fewer
- Use of antiresorptive agents such as calcitonin or bisphosphonates
- Metastatic or advanced cancer
- Current chemotherapy or radiation treatment
- Plans to move in the next three years
- Advanced liver or renal disease such that the subjects is unlikely to complete the three year intervention
- Hemaglobin >16.5 g/dl
- Bilateral hip replacement or repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Aging, University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Testosterone Effects on Bone and Frailty in Men With Osteoporosis
The purpose of this study is to assess the effects of testosterone replacement on bone density, muscle strength, physical performance, quality of life and prostate symptoms in men selected for low bone mineral density or fracture and some aspect of frailty.
Read the detailed description
The hypothesis being tested is that testosterone supplementation can increase bone mineral density and specific parameters of frailty in older men with osteoporosis and characteristics of frailty. One hundred and eighty men, age 60 years and older, who have sustained a hip fracture or other fragility fracture following mild to moderate trauma (such as a fall from standing height) in the previous 5 years or who have low femoral neck bone mineral density plus a component of frailty (weight loss, perception of exhaustion, physical strength, physical activity level and walking time) will be randomly assigned to receive either testosterone or placebo, delivered by topical gel applied daily, in a two year double-blind study.
Bone mineral density (BMD) by dual x-ray absorptiometry (DXA), will be performed at baseline and yearly to assess changes in BMD. Blood and urine samples will be collected at baseline and yearly; these tests will be correlated to changes in BMD.
To determine the effects of testosterone on frailty, strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press, respectively. Changes in lean body mass and percent body fat will be measured by total body DXA at baseline, 6 months and then annually. In addition, physical performance, emotional and sexual function, and disability will be assessed also.
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored; participants will be screened for prostate cancer at baseline, 6 months then yearly for 2 years. Fasting lipoprotein levels will be measured yearly while on testosterone replacement, and cardiovascular specific adverse effects such as angina, myocardial infarction, stroke and sudden death will be tracked.
- Conditions
- Aging, Frailty, Osteoporosis
- Being tested
- testosterone
- Keywords
- geriatric medicine, hormone therapy, HT, andropause
- Medical subject headings
- Frailty, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density and strength
Secondary outcomes (6)
Physical performance
quality of life
cognition
lipids
prostate specific antigen
prostate symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Anne Kenny, MD, Principal investigator, Center on Aging, University of Connecticut Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182871
- Sponsor's protocol ID
- AG0043
- Other IDs
- R01AG018887
- Status last verified
- Oct 2009
- First submitted
- 12 Sep 2005
- Last updated
- 30 Oct 2009
- Results posted
- No
Publications
Tenover JL. Testosterone and the aging male. J Androl. 1997 Mar-Apr;18(2):103-6.
PubMed 9154502Morley JE, Perry HM 3rd, Kaiser FE, Kraenzle D, Jensen J, Houston K, Mattammal M, Perry HM Jr. Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study. J Am Geriatr Soc. 1993 Feb;41(2):149-52. doi: 10.1111/j.1532-5415.1993.tb02049.x.
PubMed 8426037Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Holmes JH, Dlewati A, Staley J, Santanna J, Kapoor SC, Attie MF, Haddad JG Jr, Strom BL. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab. 1999 Jun;84(6):1966-72. doi: 10.1210/jcem.84.6.5741.
PubMed 10372695Kenny AM, Prestwood KM, Gruman CA, Marcello KM, Raisz LG. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M266-72. doi: 10.1093/gerona/56.5.m266.
PubMed 11320105Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M321-5. doi: 10.1093/gerona/57.5.m321.
PubMed 11983727Kenny AM, Prestwood KM, Gruman CA, Fabregas G, Biskup B, Mansoor G. Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 Jul;57(7):M460-5. doi: 10.1093/gerona/57.7.m460.
PubMed 12084809Kenny AM, Kleppinger A, Annis K, Rathier M, Browner B, Judge JO, McGee D. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. J Am Geriatr Soc. 2010 Jun;58(6):1134-43. doi: 10.1111/j.1532-5415.2010.02865.x.
PubMed 20722847
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Effects on Bone and Frailty in Men With Osteoporosis
- ClinicalTrials.gov ID
- NCT00182871
- Acronym / sponsor ID
- AG0043
- Conditions
- Aging, Frailty, Osteoporosis
- Keywords
- geriatric medicine, hormone therapy, HT, andropause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Nov 2001
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of testosterone replacement on bone density, muscle strength, physical performance, quality of life and prostate symptoms in men selected for low bone mineral density or fracture and some aspect of frailty.
Detailed description
The hypothesis being tested is that testosterone supplementation can increase bone mineral density and specific parameters of frailty in older men with osteoporosis and characteristics of frailty. One hundred and eighty men, age 60 years and older, who have sustained a hip fracture or other fragility fracture following mild to moderate trauma (such as a fall from standing height) in the previous 5 years or who have low femoral neck bone mineral density plus a component of frailty (weight loss, perception of exhaustion, physical strength, physical activity level and walking time) will be randomly assigned to receive either testosterone or placebo, delivered by topical gel applied daily, in a two year double-blind study.
Bone mineral density (BMD) by dual x-ray absorptiometry (DXA), will be performed at baseline and yearly to assess changes in BMD. Blood and urine samples will be collected at baseline and yearly; these tests will be correlated to changes in BMD.
To determine the effects of testosterone on frailty, strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press, respectively. Changes in lean body mass and percent body fat will be measured by total body DXA at baseline, 6 months and then annually. In addition, physical performance, emotional and sexual function, and disability will be assessed also.
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored; participants will be screened for prostate cancer at baseline, 6 months then yearly for 2 years. Fasting lipoprotein levels will be measured yearly while on testosterone replacement, and cardiovascular specific adverse effects such as angina, myocardial infarction, stroke and sudden death will be tracked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men over age 60 years who have sustained a femoral fracture in the preceding 3 years
- Total testosterone levels below 375 ng/dl or bioavailable testosterone levels at least 1.5 SD lower than the young adult mean
- Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
Key exclusion criteria (13 listed)
- Prostate specific antigen level over 4.0 ng/dl or the history of prostate cancer
- Disease of bone metabolism (i.e., Paget's disease, osteomalacia, hyperparathyroidism)
- History of pituitary disease
- History of sleep apnea
- Consumption of more than 3 alcoholic drinks/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone | Drug | – |
Primary outcome
Bone density and strength
6 secondary outcomes
Physical performance
quality of life
cognition
lipids
prostate specific antigen
prostate symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
- Background: PubMed 9154502Tenover JL. Testosterone and the aging male. J Androl. 1997 Mar-Apr;18(2):103-6.
- Background: PubMed 8426037Morley JE, Perry HM 3rd, Kaiser FE, Kraenzle D, Jensen J, Houston K, Mattammal M, Perry HM Jr. Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study. J Am Geriatr Soc. 1993 Feb;41(2):149-52. doi: 10.1111/j.1532-5415.1993.tb02049.x.
- Background: PubMed 10372695Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Holmes JH, Dlewati A, Staley J, Santanna J, Kapoor SC, Attie MF, Haddad JG Jr, Strom BL. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab. 1999 Jun;84(6):1966-72. doi: 10.1210/jcem.84.6.5741.
- Background: PubMed 11320105Kenny AM, Prestwood KM, Gruman CA, Marcello KM, Raisz LG. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M266-72. doi: 10.1093/gerona/56.5.m266.
- Background: PubMed 11983727Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M321-5. doi: 10.1093/gerona/57.5.m321.
- Background: PubMed 12084809Kenny AM, Prestwood KM, Gruman CA, Fabregas G, Biskup B, Mansoor G. Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 Jul;57(7):M460-5. doi: 10.1093/gerona/57.7.m460.
- Derived from this study: PubMed 20722847Kenny AM, Kleppinger A, Annis K, Rathier M, Browner B, Judge JO, McGee D. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. J Am Geriatr Soc. 2010 Jun;58(6):1134-43. doi: 10.1111/j.1532-5415.2010.02865.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kenny, MD principal investigator
Center on Aging, University of Connecticut Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing testosterone in people with Aging and Frailty, run by National Institute on Aging (NIA) at 1 site 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 13 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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Bone density and strength. 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 NCT00182871, which also lists 7 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 30 Oct 2009; AzTrials last refreshed its copy on 28 Oct 2026.