Mobility LimitationPhase 3OPTIMenNCT01275365
Optimizing Protein Intake in Older Americans With Mobility Limitations
A Phase 3 study testing Testosterone enanthate in people with Mobility Limitation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Testosterone enanthate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 19 Jan 2017
- Phase
- Phase 3
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling men 65 years of age or older
- A score of 3-10 on the short physical performance battery (SPPB)
- Daily protein intake less than the recommended daily allowance of 0.83 g/kg/day (from 3 24-hour food recalls)
- Able to give informed consent
Who cannot join
- History of prostate or breast cancer
- American Urological Association [AUA] symptom index score of >19
- Prostate specific antigen (PSA) >4 ng/ml in White men or >3 ng/ml in Black men
- Prostate specific antigen (PSA) > 4 ng/ml in non-Black men or >3 ng/ml in Black men. These subjects may be enrolled if they have a negative transrectal biopsy within the past year.
- Myocardial infarction or stroke within the last 6 months
- Uncontrolled congestive heart failure, based on the study physician's evaluation
Show all 30Show fewer
- Serum creatinine > 2.0 mg/dL; men on any kind of dialysis will be excluded.
- History of celiac disease, Crohn's disease, or ulcerative colitis
- History of any malignancy requiring treatment within the previous 2 years, except non-melanic skin cancers. Men with cancers who have not required active treatment within the past two years and who have not had disease recurrence within the past two years may be enrolled at the discretion of the study physician.
- Neuromuscular diseases: motor neuron diseases, multiple sclerosis, adult muscular dystrophies, and myasthenia gravis
- History of stroke with residual limb weakness that affected the individual's ability to walk; subjects with history of stroke who do not have residual limb weakness may be enrolled.
- Schizophrenia, bipolar disorder, or untreated diagnosed depression. Subjects with unipolar depression who are on an antidepressant medication are eligible.
- TSH levels <0.4 or >5 mlU/L
- Systolic blood pressure (BP) >160 or diastolic BP >100 mm Hg (average of 2 measurements taken at Visit 1)
- Hemoglobin A1c >8.0% or taking insulin. Men with diabetes mellitus whose A1C is less than 8.0% or who are not taking insulin will be eligible.
- Mini-Mental Status Exam [MMSE] <24
- Body mass index (BMI) less than 20 or greater than 40 kg/m2
- Not willing to eat all of the following: red meat, eggs, poultry, fish and shellfish
- Allergy to sesame, peanuts, soy, gluten or shellfish
- Current alcohol use >21 drinks/week based on self-report
- Confinement to a wheelchair
- Use of anabolic therapies (Testosterone, DHEA, androstenedione, rhGH) within the past year
- Current use of levodopa or anticoagulants
- Current enrollment in a structured weight management program or participation in any weight intervention studies in the last 90 days
- Serum ALT and AST greater than 3 x upper limit of normal
- Hematocrit < 30% or >48%
- Subject is not able to eat 3 frozen study meals per day for 6 months
- Subject is unwilling to stop current nutritional supplements
- Progressive intensive resistance training within 12 weeks of screening
- Non-compliant with run-in diet and/or supplement
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. The study will have a 2 X 2 factorial design, which will allow us to investigate the effects of dietary protein intake and testosterone separately and together.
Read the detailed description
The recommended dietary allowance (RDA) for protein, set at 0.8 grams/kg/day for adult men and women, has engendered debate and many experts advocate protein intakes substantially above the RDA to help maintain muscle anabolism in older individuals. It is not known whether increasing protein intake in older Americans, whose current intake is below the RDA, increases skeletal muscle mass, muscle performance and physical function.
Our first aim is to determine whether administration of 1.3 g/kg/day of protein, compared to the RDA (0.8 g/kg/day), will result in greater improvements in lean body mass, maximal voluntary muscle strength and power, and self-reported and performance-based measures of physical function in older men. Our second aim is to determine whether the gains in lean body mass, maximal voluntary strength and self-reported and performance-based measures of physical function during testosterone administration are greater with 1.3 g protein than with the RDA in older men on a eucaloric diet.
We will conduct a randomized, placebo-controlled, double-blind trial using a 2 X 2 factorial design. Community dwelling men, 65 years or older, who have self-reported mobility limitation, a daily protein intake of <0.8 g/kg/day and no contraindications for testosterone therapy, will be randomly assigned to one of four groups: placebo injections plus protein 0.8 g/kg/day; placebo injections plus protein 1.3 g/kg/day; testosterone enanthate 100 mg weekly plus protein 0.8 g/kg/day; testosterone enanthate 100 mg weekly plus protein 1.3 g/kg/day. Treatment duration will be 6 months. The primary outcome is change in lean body mass from baseline to 6 months, measured by dual energy X-ray absorptiometry. Secondary outcomes include change in maximal voluntary strength in leg and chest press exercises, leg power, self-reported (physical function domain of SF-36) and performance-based measures of physical function (6-min walking distance and speed, stair climbing power, and load carrying), fatigue, well-being and affectivity balance. Safety measures include urinary calcium excretion, hematocrit, prostate specific antigen (PSA) and prostate examination.
- Conditions
- Mobility Limitation
- Being tested
- Testosterone enanthate
- Keywords
- Mobility Limitation, Low Protein Intake, Older Men, Testosterone
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone enanthateDrug
Testosterone enanthate 100 mg intramuscularly weekly
Testosterone enanthateDrug
Testosterone enanthate 100 mg intramuscularly weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Low Protein | No intervention | Placebo injections weekly; 0.8 g/kg/day protein |
| Placebo/High Protein | No intervention | Placebo injections weekly; 1.3 g/kg/day protein |
| Testosterone/Low Protein | Other | Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Receives: Drug: Testosterone enanthate |
| Testosterone/High Protein | Other | Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Receives: Drug: Testosterone enanthate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
Measured: 6 months from baseline
Secondary outcomes (9)
Change of Maximal Voluntary Strength
Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.
Measured: 6 months from baseline
Change of Leg Press Power
Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.
Measured: 6 months from baseline
Change of 6-minute Walking Distance
Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance
Measured: 6 months from baseline
Change of Stair Climbing Tests
Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.
Measured: 6 months from baseline
Change of 50-meter Loaded Walking Test
Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Measured: 6 months from baseline
Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)
36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.
Measured: 6 months from baseline
Change of Psychological Well Being Index (PGWBI)
The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.
Measured: 6 months from baseline
Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Measured: 6 months from baseline
Change of Derogatis Affective Balance Scale (DABS)
The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startMay 2011
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
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 (4)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shalendar Bhasin, MD, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275365
- Sponsor's protocol ID
- 2012P001321
- Other IDs
- 7R01AG037547
- Acronym
- OPTIMen
- Status last verified
- Jul 2021
- First submitted
- 11 Jan 2011
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Huang G, Pencina K, Li Z, Apovian CM, Travison TG, Storer TW, Gagliano-Juca T, Basaria S, Bhasin S. Effect of Protein Intake on Visceral Abdominal Fat and Metabolic Biomarkers in Older Men With Functional Limitations: Results From a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 May 22;76(6):1084-1089. doi: 10.1093/gerona/glab007.
PubMed 33417663Krok-Schoen JL, Archdeacon Price A, Luo M, Kelly OJ, Taylor CA. Low Dietary Protein Intakes and Associated Dietary Patterns and Functional Limitations in an Aging Population: A NHANES analysis. J Nutr Health Aging. 2019;23(4):338-347. doi: 10.1007/s12603-019-1174-1.
PubMed 30932132Bhasin S, Apovian CM, Travison TG, Pencina K, Moore LL, Huang G, Campbell WW, Li Z, Howland AS, Chen R, Knapp PE, Singer MR, Shah M, Secinaro K, Eder RV, Hally K, Schram H, Bearup R, Beleva YM, McCarthy AC, Woodbury E, McKinnon J, Fleck G, Storer TW, Basaria S. Effect of Protein Intake on Lean Body Mass in Functionally Limited Older Men: A Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):530-541. doi: 10.1001/jamainternmed.2018.0008.
PubMed 29532075Apovian CM, Singer MR, Campbell WW, Bhasin S, McCarthy AC, Shah M, Basaria S, Moore LL. Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations. J Nutr Health Aging. 2017;21(10):1081-1088. doi: 10.1007/s12603-017-0990-4.
PubMed 29188864
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Protein Intake in Older Americans With Mobility Limitations
- ClinicalTrials.gov ID
- NCT01275365
- Acronym / sponsor ID
- OPTIMen / 2012P001321
- Conditions
- Mobility Limitation
- Keywords
- Mobility Limitation, Low Protein Intake, Older Men, Testosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2011
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. The study will have a 2 X 2 factorial design, which will allow us to investigate the effects of dietary protein intake and testosterone separately and together.
Detailed description
The recommended dietary allowance (RDA) for protein, set at 0.8 grams/kg/day for adult men and women, has engendered debate and many experts advocate protein intakes substantially above the RDA to help maintain muscle anabolism in older individuals. It is not known whether increasing protein intake in older Americans, whose current intake is below the RDA, increases skeletal muscle mass, muscle performance and physical function.
Our first aim is to determine whether administration of 1.3 g/kg/day of protein, compared to the RDA (0.8 g/kg/day), will result in greater improvements in lean body mass, maximal voluntary muscle strength and power, and self-reported and performance-based measures of physical function in older men. Our second aim is to determine whether the gains in lean body mass, maximal voluntary strength and self-reported and performance-based measures of physical function during testosterone administration are greater with 1.3 g protein than with the RDA in older men on a eucaloric diet.
We will conduct a randomized, placebo-controlled, double-blind trial using a 2 X 2 factorial design. Community dwelling men, 65 years or older, who have self-reported mobility limitation, a daily protein intake of <0.8 g/kg/day and no contraindications for testosterone therapy, will be randomly assigned to one of four groups: placebo injections plus protein 0.8 g/kg/day; placebo injections plus protein 1.3 g/kg/day; testosterone enanthate 100 mg weekly plus protein 0.8 g/kg/day; testosterone enanthate 100 mg weekly plus protein 1.3 g/kg/day. Treatment duration will be 6 months. The primary outcome is change in lean body mass from baseline to 6 months, measured by dual energy X-ray absorptiometry. Secondary outcomes include change in maximal voluntary strength in leg and chest press exercises, leg power, self-reported (physical function domain of SF-36) and performance-based measures of physical function (6-min walking distance and speed, stair climbing power, and load carrying), fatigue, well-being and affectivity balance. Safety measures include urinary calcium excretion, hematocrit, prostate specific antigen (PSA) and prostate examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo/Low Protein | No intervention | –Placebo injections weekly; 0.8 g/kg/day protein |
| Placebo/High Protein | No intervention | –Placebo injections weekly; 1.3 g/kg/day protein |
| Testosterone/Low Protein | Other | Drug: Testosterone enanthateTestosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein |
| Testosterone/High Protein | Other | Drug: Testosterone enanthateTestosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling men 65 years of age or older
- A score of 3-10 on the short physical performance battery (SPPB)
- Daily protein intake less than the recommended daily allowance of 0.83 g/kg/day (from 3 24-hour food recalls)
- Able to give informed consent
Key exclusion criteria (30 listed)
- History of prostate or breast cancer
- American Urological Association [AUA] symptom index score of >19
- Prostate specific antigen (PSA) >4 ng/ml in White men or >3 ng/ml in Black men
- Prostate specific antigen (PSA) > 4 ng/ml in non-Black men or >3 ng/ml in Black men. These subjects may be enrolled if they have a negative transrectal biopsy within the past year.
- Myocardial infarction or stroke within the last 6 months
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 enanthateTestosterone enanthate 100 mg intramuscularly weekly | Drug | Testosterone/Low Protein |
| Testosterone enanthateTestosterone enanthate 100 mg intramuscularly weekly | Drug | Testosterone/High Protein |
Primary outcome
Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
Time frame: 6 months from baseline
Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
9 secondary outcomes
Change of Maximal Voluntary Strength
Time frame: 6 months from baseline
Change of Leg Press Power
Time frame: 6 months from baseline
Change of 6-minute Walking Distance
Time frame: 6 months from baseline
Change of Stair Climbing Tests
Time frame: 6 months from baseline
Change of 50-meter Loaded Walking Test
Time frame: 6 months from baseline
Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)
Time frame: 6 months from baseline
Change of Psychological Well Being Index (PGWBI)
Time frame: 6 months from baseline
Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: 6 months from baseline
Change of Derogatis Affective Balance Scale (DABS)
Time frame: 6 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33417663Huang G, Pencina K, Li Z, Apovian CM, Travison TG, Storer TW, Gagliano-Juca T, Basaria S, Bhasin S. Effect of Protein Intake on Visceral Abdominal Fat and Metabolic Biomarkers in Older Men With Functional Limitations: Results From a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 May 22;76(6):1084-1089. doi: 10.1093/gerona/glab007.
- Derived from this study: PubMed 30932132Krok-Schoen JL, Archdeacon Price A, Luo M, Kelly OJ, Taylor CA. Low Dietary Protein Intakes and Associated Dietary Patterns and Functional Limitations in an Aging Population: A NHANES analysis. J Nutr Health Aging. 2019;23(4):338-347. doi: 10.1007/s12603-019-1174-1.
- Derived from this study: PubMed 29532075Bhasin S, Apovian CM, Travison TG, Pencina K, Moore LL, Huang G, Campbell WW, Li Z, Howland AS, Chen R, Knapp PE, Singer MR, Shah M, Secinaro K, Eder RV, Hally K, Schram H, Bearup R, Beleva YM, McCarthy AC, Woodbury E, McKinnon J, Fleck G, Storer TW, Basaria S. Effect of Protein Intake on Lean Body Mass in Functionally Limited Older Men: A Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):530-541. doi: 10.1001/jamainternmed.2018.0008.
- Derived from this study: PubMed 29188864Apovian CM, Singer MR, Campbell WW, Bhasin S, McCarthy AC, Shah M, Basaria S, Moore LL. Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations. J Nutr Health Aging. 2017;21(10):1081-1088. doi: 10.1007/s12603-017-0990-4.
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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.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone enanthate in people with Mobility Limitation, run by Brigham and Women's Hospital 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 4 inclusion and 30 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 Jul 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Feb 2018). 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?
Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA) (time frame: 6 months from baseline). 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 NCT01275365, which also lists 4 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 Jul 2021.