Type 2 Diabetes MellitusPhase 4NCT03887936
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
A Phase 4 study testing Testosterone gel 1.62% in people with Type 2 Diabetes Mellitus and Hypogonadism, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypogonadism
- What is being tested?
- Testosterone gel 1.62%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 8 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male veterans only
- 35 to 70 years old
- With an average fasting morning T level from 2 measurements of <300 ng/dl taken at least a day apart
- symptoms of hypogonadism as assessed using the androgen deficiency in aging male (ADAM) questionnaire
- Participants should have
- T2D
Show all 10Show fewer
- an A1C of <11.5 %
- a fasting blood sugar of 180 mg/dl
- body mass index (BMI) <40 kg/m2
- with DM of 15 years duration or less to target men who have relatively less complications from long-term DM
Who cannot join
- history of prostate or breast cancer
- history of testicular disease
- untreated severe sleep apnea
- ongoing illness that could prevent the subject from completing the study
- a hematocrit of >50%
- prostate-related findings as:
Show all 42Show fewer
- a palpable prostate nodule on digital rectal exam (DRE)
- serum PSA of 4.0 ng/ml
- International Prostate Symptom Score (IPSS) >19 (severe)
- on androgen therapy or selective androgen receptor modulators
- on medications that affect bone metabolism such as:
- estrogen
- selective estrogen receptor modulator as:
- raloxifene
- aromatase inhibitors
- GnRH analogs
- glucocorticoids with prednisone equivalent of least 5 mg daily for 1 month
- anabolic steroids
- phenobarbital and Dilantin
- use of bisphosphonates within two years of study entry, i.e.:
- risedronate
- alendronate
- zoledronic acid
- pamidronate
- diseases that interfere with bone metabolism, as:
- hyperparathyroidism
- untreated hyperthyroidism
- osteomalacia
- chronic liver disease
- renal failure with estimated glomerular filtration rate of <45 ml/min
- hypercortisolism
- malabsorption
- immobilization
- current alcohol use of > 3 drinks/day
- those with a history of:
- deep vein thrombosis
- pulmonary embolism
- recent stroke or recent diagnosis of coronary artery disease of < 6 months
- because of the potential of being randomized to placebo, subjects with osteoporosis or a BMD T-score by DXA of -2.5 in the lumbar spine, total femur or femoral neck and those with a history of fragility fractures
- spine
- hip
- wrist
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
About this study
Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.
Read the detailed description
An existing mutual influence between testosterone (T) and glucose metabolism has been suggested by studies showing that men with low T have impaired glucose tolerance, while a significant number of men with type 2 diabetes mellitus (T2D) and obesity have low T. Thus, it is not surprising that as much as 64% of men with T2D were found to have low T. Hypogonadism and diabetes mellitus (DM) each is associated with increased risk for fractures. While hypogonadism is associated with increased bone turnover and bone loss. DM is associated with low bone turnover and normal or high bone mineral density (BMD) but paradoxically a high risk for fractures. The preliminary data showed that compared to non-diabetic hypogonadal men, men with both conditions have suppressed bone turnover, higher volumetric BMD (vBMD) and smaller bone size. As the effect of T on the male skeleton is mainly mediated by its conversion to estradiol (E2) by the enzyme aromatase, the possibility of further suppression of bone turnover with T therapy in these patients would be a concern. However, the investigators' initial data also showed that T therapy in men with both conditions resulted in increased in markers of bone turnover and bone size compared to the decrease in bone turnover and decrease in bone size in men with hypogonadism only, suggesting activation in bone remodeling and improvement in bone geometry in the former. Furthermore, the investigators also found a trend for increase in bone strength (by finite element analysis or FEA) in the limited number of men with both low T and T2D randomized to T compared to placebo. These findings only suggest but do not prove with certainty that T therapy would be beneficial to men with both low T and T2D. The central hypothesis of this study is that T therapy will result in improvement in bone quality in patients who have both hypogonadism and T2D. Thus, the specific aims of this proposal are: 1) to determine the effect of T therapy on bone strength as assessed by finite element analysis ( FEA) using high-resolution peripheral quantitative computer tomography (HR-pQCT), 2) to determine the effect of T therapy on markers of bone turnover, and 3) an exploratory aim, to evaluate the mechanism for improvement in bone quality from T therapy. The investigators hypothesize that because T stimulates osteoblastic proliferation and differentiation, the ensuing increase in osteoblast number will lead to an enhanced cross-talk between osteoblast and osteoclast resulting in activation of bone remodeling and replacement of old with new bone, hence, improvement in bone quality. In this study the investigators will enroll 166 men with T2D and hypogonadism and randomize them to either testosterone gel 1.62% or placebo for 12 months.
The following main outcomes will be evaluated: aim# 1) change in the primary endpoint which is FEA, by HRpQCT, #2) changes in C-telopeptide (CTX) a marker of bone resorption, and aim #3) changes in circulating osteoblast progenitor (COP). The investigators anticipate an increase in FEA at the tibia and radius suggesting improvement in bone strength, increase CTX and increase in circulating osteoblast progenitors. The investigators further anticipate an increase in other markers of bone turnover (both bone formation and resorption) and osteoclast precursors in men with hypogonadism and T2D randomized to T compared to placebo. Given the suppressed bone turnover at baseline in men with low T and T2D, the investigators hypothesize that the beneficial effect of T is its effect in activating bone remodeling ultimately resulting in improvement in bone quality.
Results from this study will provide information on the utility of T not only in improving quality of life but also in improving bone quality in hypogonadal men with T2D. Given the relationship between glucose metabolism and testosterone production, and the increasing number of male patients diagnosed with both hypogonadism and T2D, this study will benefit not only the significant number of male Veterans who have both conditions but also men in general.
- Conditions
- Type 2 Diabetes Mellitus, Hypogonadism
- Being tested
- Testosterone gel 1.62%, Placebo
- Keywords
- diabetes mellitus, hypogonadism, testosterone, bone quality
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypogonadism, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gel 1.62%Drug
Also called Androgel
Testosterone gel 1.62%, apply 2 pumps to upper arm and shoulder.
PlaceboDrug
Matching placebo gel, apply 2 pumps to upper arm and shoulder
| Study group | Role | What they receive |
|---|---|---|
| Testosterone arm | Experimental | Testosterone gel 1.62% Receives: Drug: Testosterone gel 1.62% |
| Placebo arm | Placebo comparator | Matching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finite Element Analysis of Bone to Measure Bone Strength
The FEA (or FEA) is a surrogate measure of strength using computational biomechanical principles and integrate bone morphology and bone mass to calculate bone strength under various loading conditions normally seen in daily living activities. In addition, the ratio of load to strength can be calculated by using patient information (i.e. weight and height) and FEA derived bone strength to mechanistically simulate bone failure and thus, whether fracture is likely during a given activity. Using high-resolution peripheral quantitative computer tomography (HRPQCT) we will compute for FEA, using FEA software with images generated using Image Processing Language to estimate the biomechanical properties of the bone. Each bone voxel will be converted to hexahedral finite elements with linear-elastic and isotropic material behavior. The FEA model will be subject to uniaxial compression and stiffness and failure load will be estimated. FEA will be assessed at months 0, 6 and 12.
Measured: months 0, 6 and 12
Secondary outcomes (2)
Markers of Bone Turnover to Measure Bone Metabolism
Two markers of bone resorption, serum C-telopeptide (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b) and 2 markers of bone formation osteocalcin (OCN) and N-terminal propeptide of type 1 collagen (P1NP) will be evaluated. These markers will be obtained at months 0, 6, and 12. Enzyme-linked immunosorbent assay will be used to measure serum CTX (serum crosslaps, Osteometer, Hawthorne, CA), tartrate-resistant acid phosphatase 5b (TRAP5b) (EIA) (Microvue Bonehealth, Quidel Corporation, Biosource); and serum osteocalcin (ALPCO, Salem, NH). Serum P1NP will be measured by competitive radioimmunoassay (UniqTM P1NP RIA, Immunodiagnostic Systems, Scottsdale, AZ). Coefficients of variations for these assays are <10%.
Measured: months 0, 6 and 12
Osteoblast and Osteoclast Progenitor Cells Which Are Cells Found in Bone
Osteoblast and osteoclast progenitor cells will be harvested from the serum at baseline, 6 and 12 months.
Measured: months 0, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Oct 2019
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Double-blind randomized placebo-controlled study comparing the effect of testosterone therapy in men with both type 2 diabetes mellitus and hypogonadism on bone quality, bone turnover markers and circulating osteoblast and osteoclast progenitors.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Reina C. Villareal, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887936
- Sponsor's protocol ID
- ENDB-009-18F
- Other IDs
- 1I01CX001665-01A2
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2019
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russo V, Chen R, Armamento-Villareal R. Hypogonadism, Type-2 Diabetes Mellitus, and Bone Health: A Narrative Review. Front Endocrinol (Lausanne). 2021 Jan 18;11:607240. doi: 10.3389/fendo.2020.607240. eCollection 2020.
PubMed 33537005Deepika F, Ballato E, Colleluori G, Aguirre L, Chen R, Qualls C, Villareal DT, Armamento-Villareal R. Baseline Testosterone Predicts Body Composition and Metabolic Response to Testosterone Therapy. Front Endocrinol (Lausanne). 2022 Jul 11;13:915309. doi: 10.3389/fendo.2022.915309. eCollection 2022.
PubMed 35898448Bathina S, Armamento-Villareal R. The complex pathophysiology of bone fragility in obesity and type 2 diabetes mellitus: therapeutic targets to promote osteogenesis. Front Endocrinol (Lausanne). 2023 Jul 20;14:1168687. doi: 10.3389/fendo.2023.1168687. eCollection 2023.
PubMed 37576965Deepika F, Bathina S, Armamento-Villareal R. Novel Adipokines and Their Role in Bone Metabolism: A Narrative Review. Biomedicines. 2023 Feb 20;11(2):644. doi: 10.3390/biomedicines11020644.
PubMed 36831180Bathina S, Prado M, Fuenmayor Lopez V, Colleluori G, Aguirre L, Chen R, Villareal DT, Armamento-Villareal R. PRDM16 Enhances Osteoblastogenic RUNX2 via Canonical WNT10b/beta-CATENIN Pathway in Testosterone-Treated Hypogonadal Men. Biomolecules. 2025 Jan 8;15(1):79. doi: 10.3390/biom15010079.
PubMed 39858473Chen R, Armamento-Villareal R. Obesity and Skeletal Fragility. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e466-e477. doi: 10.1210/clinem/dgad415.
PubMed 37440585Russo V, Colleluori G, Chen R, Mediwala S, Qualls C, Liebschner M, Villareal DT, Armamento-Villareal R. Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol. Contemp Clin Trials Commun. 2021 Jan 20;21:100723. doi: 10.1016/j.conctc.2021.100723. eCollection 2021 Mar.
PubMed 33718653Ballato E, Deepika FNU, Russo V, Fleires-Gutierrez A, Colleluori G, Fuenmayor V, Chen R, Villareal DT, Qualls C, Armamento-Villareal R. One-Year Mean A1c of > 7% is Associated with Poor Bone Microarchitecture and Strength in Men with Type 2 Diabetes Mellitus. Calcif Tissue Int. 2022 Sep;111(3):267-278. doi: 10.1007/s00223-022-00993-x. Epub 2022 Jun 4.
PubMed 35665818Bathina S, Lopez VF, Prado M, Ballato E, Colleluori G, Tetlay M, Villareal DT, Mediwala S, Chen R, Qualls C, Armamento-Villareal R. Health implications of racial differences in serum growth differentiation factor levels among men with obesity. Physiol Rep. 2024 Dec;12(23):e70124. doi: 10.14814/phy2.70124.
PubMed 39668628Ballato E, Deepika F, Prado M, Russo V, Fuenmayor V, Bathina S, Villareal DT, Qualls C, Armamento-Villareal R. Circulating osteogenic progenitors and osteoclast precursors are associated with long-term glycemic control, sex steroids, and visceral adipose tissue in men with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022 Sep 12;13:936159. doi: 10.3389/fendo.2022.936159. eCollection 2022.
PubMed 36171900
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
- ClinicalTrials.gov ID
- NCT03887936
- Acronym / sponsor ID
- ENDB-009-18F
- Conditions
- Type 2 Diabetes Mellitus, Hypogonadism
- Keywords
- diabetes mellitus, hypogonadism, testosterone, bone quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.
Detailed description
An existing mutual influence between testosterone (T) and glucose metabolism has been suggested by studies showing that men with low T have impaired glucose tolerance, while a significant number of men with type 2 diabetes mellitus (T2D) and obesity have low T. Thus, it is not surprising that as much as 64% of men with T2D were found to have low T. Hypogonadism and diabetes mellitus (DM) each is associated with increased risk for fractures. While hypogonadism is associated with increased bone turnover and bone loss. DM is associated with low bone turnover and normal or high bone mineral density (BMD) but paradoxically a high risk for fractures. The preliminary data showed that compared to non-diabetic hypogonadal men, men with both conditions have suppressed bone turnover, higher volumetric BMD (vBMD) and smaller bone size. As the effect of T on the male skeleton is mainly mediated by its conversion to estradiol (E2) by the enzyme aromatase, the possibility of further suppression of bone turnover with T therapy in these patients would be a concern. However, the investigators' initial data also showed that T therapy in men with both conditions resulted in increased in markers of bone turnover and bone size compared to the decrease in bone turnover and decrease in bone size in men with hypogonadism only, suggesting activation in bone remodeling and improvement in bone geometry in the former. Furthermore, the investigators also found a trend for increase in bone strength (by finite element analysis or FEA) in the limited number of men with both low T and T2D randomized to T compared to placebo. These findings only suggest but do not prove with certainty that T therapy would be beneficial to men with both low T and T2D. The central hypothesis of this study is that T therapy will result in improvement in bone quality in patients who have both hypogonadism and T2D. Thus, the specific aims of this proposal are: 1) to determine the effect of T therapy on bone strength as assessed by finite element analysis ( FEA) using high-resolution peripheral quantitative computer tomography (HR-pQCT), 2) to determine the effect of T therapy on markers of bone turnover, and 3) an exploratory aim, to evaluate the mechanism for improvement in bone quality from T therapy. The investigators hypothesize that because T stimulates osteoblastic proliferation and differentiation, the ensuing increase in osteoblast number will lead to an enhanced cross-talk between osteoblast and osteoclast resulting in activation of bone remodeling and replacement of old with new bone, hence, improvement in bone quality. In this study the investigators will enroll 166 men with T2D and hypogonadism and randomize them to either testosterone gel 1.62% or placebo for 12 months.
The following main outcomes will be evaluated: aim# 1) change in the primary endpoint which is FEA, by HRpQCT, #2) changes in C-telopeptide (CTX) a marker of bone resorption, and aim #3) changes in circulating osteoblast progenitor (COP). The investigators anticipate an increase in FEA at the tibia and radius suggesting improvement in bone strength, increase CTX and increase in circulating osteoblast progenitors. The investigators further anticipate an increase in other markers of bone turnover (both bone formation and resorption) and osteoclast precursors in men with hypogonadism and T2D randomized to T compared to placebo. Given the suppressed bone turnover at baseline in men with low T and T2D, the investigators hypothesize that the beneficial effect of T is its effect in activating bone remodeling ultimately resulting in improvement in bone quality.
Results from this study will provide information on the utility of T not only in improving quality of life but also in improving bone quality in hypogonadal men with T2D. Given the relationship between glucose metabolism and testosterone production, and the increasing number of male patients diagnosed with both hypogonadism and T2D, this study will benefit not only the significant number of male Veterans who have both conditions but also men in general.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized placebo-controlled study comparing the effect of testosterone therapy in men with both type 2 diabetes mellitus and hypogonadism on bone quality, bone turnover markers and circulating osteoblast and osteoclast progenitors.
| Arm | Type | Receives |
|---|---|---|
| Testosterone arm | Experimental | Drug: Testosterone gel 1.62%Testosterone gel 1.62% |
| Placebo arm | Placebo comparator | Drug: PlaceboMatching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male veterans only
- 35 to 70 years old
- With an average fasting morning T level from 2 measurements of <300 ng/dl taken at least a day apart
- Participants should have
Key exclusion criteria (42 listed)
- history of prostate or breast cancer
- history of testicular disease
- untreated severe sleep apnea
- ongoing illness that could prevent the subject from completing the study
- a hematocrit of >50%
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 gel 1.62%Also: AndrogelTestosterone gel 1.62%, apply 2 pumps to upper arm and shoulder. | Drug | Testosterone arm |
| PlaceboMatching placebo gel, apply 2 pumps to upper arm and shoulder | Drug | Placebo arm |
Primary outcome
Finite Element Analysis of Bone to Measure Bone Strength
Time frame: months 0, 6 and 12
The FEA (or FEA) is a surrogate measure of strength using computational biomechanical principles and integrate bone morphology and bone mass to calculate bone strength under various loading conditions normally seen in daily living activities. In addition, the ratio of load to strength can be calculated by using patient information (i.e. weight and height) and FEA derived bone strength to mechanistically simulate bone failure and thus, whether fracture is likely during a given activity. Using high-resolution peripheral quantitative computer tomography (HRPQCT) we will compute for FEA, using FEA software with images generated using Image Processing Language to estimate the biomechanical properties of the bone. Each bone voxel will be converted to hexahedral finite elements with linear-elastic and isotropic material behavior. The FEA model will be subject to uniaxial compression and stiffness and failure load will be estimated. FEA will be assessed at months 0, 6 and 12.
2 secondary outcomes
Markers of Bone Turnover to Measure Bone Metabolism
Time frame: months 0, 6 and 12
Osteoblast and Osteoclast Progenitor Cells Which Are Cells Found in Bone
Time frame: months 0, 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33537005Russo V, Chen R, Armamento-Villareal R. Hypogonadism, Type-2 Diabetes Mellitus, and Bone Health: A Narrative Review. Front Endocrinol (Lausanne). 2021 Jan 18;11:607240. doi: 10.3389/fendo.2020.607240. eCollection 2020.
- Background: PubMed 35898448Deepika F, Ballato E, Colleluori G, Aguirre L, Chen R, Qualls C, Villareal DT, Armamento-Villareal R. Baseline Testosterone Predicts Body Composition and Metabolic Response to Testosterone Therapy. Front Endocrinol (Lausanne). 2022 Jul 11;13:915309. doi: 10.3389/fendo.2022.915309. eCollection 2022.
- Background: PubMed 37576965Bathina S, Armamento-Villareal R. The complex pathophysiology of bone fragility in obesity and type 2 diabetes mellitus: therapeutic targets to promote osteogenesis. Front Endocrinol (Lausanne). 2023 Jul 20;14:1168687. doi: 10.3389/fendo.2023.1168687. eCollection 2023.
- Background: PubMed 36831180Deepika F, Bathina S, Armamento-Villareal R. Novel Adipokines and Their Role in Bone Metabolism: A Narrative Review. Biomedicines. 2023 Feb 20;11(2):644. doi: 10.3390/biomedicines11020644.
- Background: PubMed 39858473Bathina S, Prado M, Fuenmayor Lopez V, Colleluori G, Aguirre L, Chen R, Villareal DT, Armamento-Villareal R. PRDM16 Enhances Osteoblastogenic RUNX2 via Canonical WNT10b/beta-CATENIN Pathway in Testosterone-Treated Hypogonadal Men. Biomolecules. 2025 Jan 8;15(1):79. doi: 10.3390/biom15010079.
- Background: PubMed 37440585Chen R, Armamento-Villareal R. Obesity and Skeletal Fragility. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e466-e477. doi: 10.1210/clinem/dgad415.
- Results publication: PubMed 33718653Russo V, Colleluori G, Chen R, Mediwala S, Qualls C, Liebschner M, Villareal DT, Armamento-Villareal R. Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol. Contemp Clin Trials Commun. 2021 Jan 20;21:100723. doi: 10.1016/j.conctc.2021.100723. eCollection 2021 Mar.
- Results publication: PubMed 35665818Ballato E, Deepika FNU, Russo V, Fleires-Gutierrez A, Colleluori G, Fuenmayor V, Chen R, Villareal DT, Qualls C, Armamento-Villareal R. One-Year Mean A1c of > 7% is Associated with Poor Bone Microarchitecture and Strength in Men with Type 2 Diabetes Mellitus. Calcif Tissue Int. 2022 Sep;111(3):267-278. doi: 10.1007/s00223-022-00993-x. Epub 2022 Jun 4.
- Results publication: PubMed 39668628Bathina S, Lopez VF, Prado M, Ballato E, Colleluori G, Tetlay M, Villareal DT, Mediwala S, Chen R, Qualls C, Armamento-Villareal R. Health implications of racial differences in serum growth differentiation factor levels among men with obesity. Physiol Rep. 2024 Dec;12(23):e70124. doi: 10.14814/phy2.70124.
- Results publication: PubMed 36171900Ballato E, Deepika F, Prado M, Russo V, Fuenmayor V, Bathina S, Villareal DT, Qualls C, Armamento-Villareal R. Circulating osteogenic progenitors and osteoclast precursors are associated with long-term glycemic control, sex steroids, and visceral adipose tissue in men with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022 Sep 12;13:936159. doi: 10.3389/fendo.2022.936159. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Reina C. Villareal, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
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 gel 1.62% in people with Type 2 Diabetes Mellitus and Hypogonadism, run by VA Office of Research and Development 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 10 inclusion and 42 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 29 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Finite Element Analysis of Bone to Measure Bone Strength (time frame: months 0, 6 and 12). 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 NCT03887936, which also lists 10 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 29 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.