Osteoarthritis, HipPhase 4NCT06608914
Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty
A Phase 4 study testing Nandrolone decanoate and Saline in people with Osteoarthritis, Hip, run by American Hip Institute.
Trial summary
It is often observed that patients following total hip replacement have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Nandrolone decanoate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients over the age of 18 with a diagnosis of osteoarthritis or dysplasia that are undergoing total hip replacement will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of osteoarthritis or dysplasia, age 18 and older, and hypogonadism, defined as a testosterone level \<300ng/dL or clinical signs of hypogonadism including reduced muscle mass and strength, decreased libido, erectile dysfunction, loss of body hair, low bone mineral density, infertility, gynecomastia, or incomplete or delayed sexual development.
Who cannot join
- Major exclusion criteria include previous arthroplasty of the affected hip, previous spine surgery, a past medical history significant for allergy to testosterone, prostate cancer, PSA \>4 ng/ml, breast cancer, polycythemia, diabetes mellitus with a HbA1c \> 7, BMI \<18 or \> 40, and preoperative motion or strength limitations that will affect postoperative rehabilitation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
It is often observed that patients following total hip replacement have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. The goal of this study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass, as well as to see if it will improve their outcomes after surgery. The main question this study aims to answer is: Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo?
Researchers will compare patients who were administered testosterone to standard of care (no administration of testosterone) to see if there is a difference in their recovery and outcomes.
Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery. Participants will have to answer questionnaires on how they are doing, as well as will do other testing during this time.
Read the detailed description
The purpose of this double blinded, randomized controlled trial is to determine if weekly intramuscular testosterone administration can prevent short-term catabolic loss of lean mass in patients undergoing total hip arthroplasty in addition to improving functional and patient-reported outcome scores. It is hypothesized that perioperative testosterone administration will increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo. This is the first study, to our knowledge, investigating the effects of perioperative testosterone administration on male patients undergoing total hip arthroplasty.
Participants will be randomly assigned to receive testosterone or placebo treatment. This will be performed using a simple 1:1 randomization and will be provided to the study's designated team member who is not associated with the study, to be referred to as the pharmacist. Except for the statistician performing the randomization and the pharmacist, all individuals involved - including the investigators, study team, surgeon, physical therapist, and patient - will be blinded to the assigned treatment.
Informed consent documentation will include an in-depth discussion of the possible, but uncommon, risks of testosterone including allergic reactions, liver function test alterations, breast tenderness, hair growth or loss, polycythemia, and mood or mental changes. These potential adverse events will be monitored during all study visits.
The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate (also known as Nandrolone) weekly for 8 weeks beginning 2 weeks prior to surgery. The 200 mg per week regimen is being selected with the goal of being a dose sufficient to provide an anabolic stimulus, and low enough to minimize potential adverse effects [10-13]. Control participants in the placebo group will follow the same schedule of injections with an intramuscular dose of saline instead of testosterone. All participants will follow a structured, standard of care, rehabilitation protocol within one week of surgery. All participants will follow a structured, standard of care, rehabilitation protocol within one week of surgery. Common markers of endocrine function will be monitored for potential systemic side effects of testosterone using blood analysis of pituitary hormones including luteinizing hormone (LH) and follicle stimulating hormone (FSH), prostate-specific antigen (PSA), alanine aminotransferase (ALT), hematocrit, hemoglobin, and white blood cell at 2 weeks preoperatively, the day of surgery, and then 2 weeks, 6 weeks, 3 months, and 2 years postoperatively.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Nandrolone decanoate, Saline
- Keywords
- testosterone, hypogonadism, total hip replacement, total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nandrolone decanoateDrug
Nandrolone will be administered to the testosterone group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.
SalineDrug
Saline will be administered to the saline group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone arm | Experimental | The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate (also known as Nandrolone) weekly for 8 weeks beginning 2 weeks prior to surgery. Receives: Drug: Nandrolone decanoate |
| Saline Arm | Placebo comparator | The saline group will receive a 200mg dose of intramuscular saline weekly for 8 weeks beginning 2 weeks prior to surgery. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Harris Hip Score
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome
Measured: 2 years
Secondary outcomes (3)
HOS-SSS
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome
Measured: 2 years
iHOT-12
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome
Measured: 2 years
Total lean body mass
Measuring total lean body mass via Lunar IDXA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study startJan 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Hip Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608914
- Sponsor's protocol ID
- AHI-005
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.
PubMed 11701431Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G. Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA. 2000 Feb 9;283(6):763-70. doi: 10.1001/jama.283.6.763.
PubMed 10683055Basaria S, Wahlstrom JT, Dobs AS. Clinical review 138: Anabolic-androgenic steroid therapy in the treatment of chronic diseases. J Clin Endocrinol Metab. 2001 Nov;86(11):5108-17. doi: 10.1210/jcem.86.11.7983.
PubMed 11701661Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.
PubMed 20592293Sattler FR, Castaneda-Sceppa C, Binder EF, Schroeder ET, Wang Y, Bhasin S, Kawakubo M, Stewart Y, Yarasheski KE, Ulloor J, Colletti P, Roubenoff R, Azen SP. Testosterone and growth hormone improve body composition and muscle performance in older men. J Clin Endocrinol Metab. 2009 Jun;94(6):1991-2001. doi: 10.1210/jc.2008-2338. Epub 2009 Mar 17.
PubMed 19293261Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101.
PubMed 8637535Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.
PubMed 12366624Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
PubMed 28840147Serra C, Bhasin S, Tangherlini F, Barton ER, Ganno M, Zhang A, Shansky J, Vandenburgh HH, Travison TG, Jasuja R, Morris C. The role of GH and IGF-I in mediating anabolic effects of testosterone on androgen-responsive muscle. Endocrinology. 2011 Jan;152(1):193-206. doi: 10.1210/en.2010-0802. Epub 2010 Nov 17.
PubMed 21084444White JP, Baltgalvis KA, Sato S, Wilson LB, Carson JA. Effect of nandrolone decanoate administration on recovery from bupivacaine-induced muscle injury. J Appl Physiol (1985). 2009 Nov;107(5):1420-30. doi: 10.1152/japplphysiol.00668.2009. Epub 2009 Sep 10.
PubMed 19745189Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.
PubMed 21475673Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Beck EC, Nwachukwu BU, Krivicich LM, Malloy P, Suppauksorn S, Jan K, Nho SJ. Preoperative Hip Extension Strength Is an Independent Predictor of Achieving Clinically Significant Outcomes After Hip Arthroscopy for Femoroacetabular Impingement Syndrome. Sports Health. 2020 Jul/Aug;12(4):361-372. doi: 10.1177/1941738120910134. Epub 2020 May 11.
PubMed 32392094
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06608914
- Acronym / sponsor ID
- AHI-005
- Conditions
- Osteoarthritis, Hip
- Keywords
- testosterone, hypogonadism, total hip replacement, total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- American Hip InstituteUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- 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.
It is often observed that patients following total hip replacement have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. The goal of this study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass, as well as to see if it will improve their outcomes after surgery. The main question this study aims to answer is: Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo?
Researchers will compare patients who were administered testosterone to standard of care (no administration of testosterone) to see if there is a difference in their recovery and outcomes.
Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery. Participants will have to answer questionnaires on how they are doing, as well as will do other testing during this time.
Detailed description
The purpose of this double blinded, randomized controlled trial is to determine if weekly intramuscular testosterone administration can prevent short-term catabolic loss of lean mass in patients undergoing total hip arthroplasty in addition to improving functional and patient-reported outcome scores. It is hypothesized that perioperative testosterone administration will increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo. This is the first study, to our knowledge, investigating the effects of perioperative testosterone administration on male patients undergoing total hip arthroplasty.
Participants will be randomly assigned to receive testosterone or placebo treatment. This will be performed using a simple 1:1 randomization and will be provided to the study's designated team member who is not associated with the study, to be referred to as the pharmacist. Except for the statistician performing the randomization and the pharmacist, all individuals involved - including the investigators, study team, surgeon, physical therapist, and patient - will be blinded to the assigned treatment.
Informed consent documentation will include an in-depth discussion of the possible, but uncommon, risks of testosterone including allergic reactions, liver function test alterations, breast tenderness, hair growth or loss, polycythemia, and mood or mental changes. These potential adverse events will be monitored during all study visits.
The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate (also known as Nandrolone) weekly for 8 weeks beginning 2 weeks prior to surgery. The 200 mg per week regimen is being selected with the goal of being a dose sufficient to provide an anabolic stimulus, and low enough to minimize potential adverse effects [10-13]. Control participants in the placebo group will follow the same schedule of injections with an intramuscular dose of saline instead of testosterone. All participants will follow a structured, standard of care, rehabilitation protocol within one week of surgery. All participants will follow a structured, standard of care, rehabilitation protocol within one week of surgery. Common markers of endocrine function will be monitored for potential systemic side effects of testosterone using blood analysis of pituitary hormones including luteinizing hormone (LH) and follicle stimulating hormone (FSH), prostate-specific antigen (PSA), alanine aminotransferase (ALT), hematocrit, hemoglobin, and white blood cell at 2 weeks preoperatively, the day of surgery, and then 2 weeks, 6 weeks, 3 months, and 2 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone arm | Experimental | Drug: Nandrolone decanoateThe testosterone group will receive a 200mg dose of intramuscular testosterone cypionate (also known as Nandrolone) weekly for 8 weeks beginning 2 weeks prior to surgery. |
| Saline Arm | Placebo comparator | Drug: SalineThe saline group will receive a 200mg dose of intramuscular saline weekly for 8 weeks beginning 2 weeks prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients over the age of 18 with a diagnosis of osteoarthritis or dysplasia that are undergoing total hip replacement will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of osteoarthritis or dysplasia, age 18 and older, and hypogonadism, defined as a testosterone level \<300ng/dL or clinical signs of hypogonadism including reduced muscle mass and strength, decreased libido, erectile dysfunction, loss of body hair, low bone mineral density, infertility, gynecomastia, or incomplete or delayed sexual development.
Key exclusion criteria (1 listed)
- Major exclusion criteria include previous arthroplasty of the affected hip, previous spine surgery, a past medical history significant for allergy to testosterone, prostate cancer, PSA \>4 ng/ml, breast cancer, polycythemia, diabetes mellitus with a HbA1c \> 7, BMI \<18 or \> 40, and preoperative motion or strength limitations that will affect postoperative rehabilitation.
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 |
|---|---|---|
| Nandrolone decanoateNandrolone will be administered to the testosterone group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery. | Drug | Testosterone arm |
| SalineSaline will be administered to the saline group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery. | Drug | Saline Arm |
Primary outcome
modified Harris Hip Score
Time frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome
3 secondary outcomes
HOS-SSS
Time frame: 2 years
iHOT-12
Time frame: 2 years
Total lean body mass
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 11701431Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.
- Background: PubMed 10683055Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G. Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA. 2000 Feb 9;283(6):763-70. doi: 10.1001/jama.283.6.763.
- Background: PubMed 11701661Basaria S, Wahlstrom JT, Dobs AS. Clinical review 138: Anabolic-androgenic steroid therapy in the treatment of chronic diseases. J Clin Endocrinol Metab. 2001 Nov;86(11):5108-17. doi: 10.1210/jcem.86.11.7983.
- Background: PubMed 20592293Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.
- Background: PubMed 19293261Sattler FR, Castaneda-Sceppa C, Binder EF, Schroeder ET, Wang Y, Bhasin S, Kawakubo M, Stewart Y, Yarasheski KE, Ulloor J, Colletti P, Roubenoff R, Azen SP. Testosterone and growth hormone improve body composition and muscle performance in older men. J Clin Endocrinol Metab. 2009 Jun;94(6):1991-2001. doi: 10.1210/jc.2008-2338. Epub 2009 Mar 17.
- Background: PubMed 8637535Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101.
- Background: PubMed 12366624Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.
- Background: PubMed 28840147Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
- Background: PubMed 21084444Serra C, Bhasin S, Tangherlini F, Barton ER, Ganno M, Zhang A, Shansky J, Vandenburgh HH, Travison TG, Jasuja R, Morris C. The role of GH and IGF-I in mediating anabolic effects of testosterone on androgen-responsive muscle. Endocrinology. 2011 Jan;152(1):193-206. doi: 10.1210/en.2010-0802. Epub 2010 Nov 17.
- Background: PubMed 19745189White JP, Baltgalvis KA, Sato S, Wilson LB, Carson JA. Effect of nandrolone decanoate administration on recovery from bupivacaine-induced muscle injury. J Appl Physiol (1985). 2009 Nov;107(5):1420-30. doi: 10.1152/japplphysiol.00668.2009. Epub 2009 Sep 10.
- Background: PubMed 21475673Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nandrolone decanoate and Saline in people with Osteoarthritis, Hip, run by American Hip Institute.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Domb, MD (8338724477, drdomb@americanhipinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Harris Hip Score (time frame: 2 years). 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 NCT06608914, which also lists 13 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 1 Jan 2025.