Knee Osteoarthritis (Knee OA)Phase 1/2KORRNCT07036003
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
A Phase 1/2 study testing Somatropin (recombinant human growth hormone) in people with Knee Osteoarthritis (Knee OA) and Knee Osteoarthritis (OA), run by Dr. David Wasserstein at 1 site in Canada.
Trial summary
The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA), Knee Osteoarthritis (OA)
- What is being tested?
- Somatropin (recombinant human growth hormone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2025to Jan 2029
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 - 65 years old.
- Diagnosis of isolated knee osteoarthritis for greater than 6 months.
Who cannot join
- Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament repair/reconstruction, or cartilage transplantation. Patients with remote (>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.
- Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative/complex meniscal tears (>6 months from injury) may be included at the investigators' discretion
- Recent (less than 6 months) intra-articular injection into the involved knee.
- High grade ligamentous knee injury.
- Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.
- BMI of less than 20 or greater than 35.
Show all 13Show fewer
- Documented history of growth disorder of bones or connective tissue, type 1 or 2 diabetes, myopathy, cancer, endocrine disorder, severe hypertension (SBP > 180) or rheumatologic disorder.
- Pregnant or breastfeeding, or actively attempting to get pregnant.
- Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy.
- Would have difficulty with the self-injection schedule or other cognitive/ functional limitations.
- Have taken creatine within 7 days before baseline. Potential participants will be given the option to pause their supplements and then re-screen if they are interested in the study,
- Have taken anabolic steroids within 42 days (6 weeks) before baseline. Potential participants will be given the option to pause their supplements and then rescreen if they are interested in the study,
- Vital signs or routine bloodwork outside of normal range.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial
The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan.
Participants will be asked to:
- Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.
- Complete questionnaires related to their knee pain and activities of daily living.
- Provide blood tests.
- Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.
- Being tested
- Somatropin (recombinant human growth hormone), bacteriostatic saline placebo
- Keywords
- Recombinant Human Growth Hormone, rHGH, Saizen, Knee Osteoarthritis, Knee OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin (recombinant human growth hormone)Drug
Study participants will deliver Somatropin via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks at a dose of 0.5mg/day per body surface area (0.5mg/m2/day).
bacteriostatic saline placeboDrug
Study participants will deliver bacteriostatic saline via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks in an identical delivery device to the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Growth Hormone (rHGH) | Experimental | Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. Receives: Drug: Somatropin (recombinant human growth hormone) |
| Bacteriostatic Saline | Placebo comparator | Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. Receives: Drug: bacteriostatic saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the medication administration
Participant adheres to self-administration of injections once daily for 6 weeks.
Measured: 6 weeks after treatment begins.
Secondary outcomes (13)
Clinical Outcomes: knee extension strength
Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system.
Measured: At 6 weeks and 24 months time points after enrolment
Clinical Outcome: knee flexion strength
Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system.
Measured: At 24 months after enrolment.
Clinical Outcomes: thigh muscle strength
Participants' thigh muscle strength will be measured through hip flexion, hip abduction and knee flexion using a goniometer.
Measured: At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.
Clinical Outcomes: Kinematic Gait Analysis
Participants' kinematic gait analysis will be measured with single/ two leg hop/jump and single/ two leg squat, using the Theia Markerless system before and after treatment.
Measured: At baseline, 6 weeks and 6 months study visits.
Thigh circumference
Participant's measurements of function will be measured by their thigh circumference compared to the contralateral leg, and baseline.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Mid-calf circumference
Participant's measurements of function will be measured by their mid-calf circumference compared to the contralateral leg, and baseline.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Abdominal circumference
Participant's measurements of function will be measured by their abdominal circumference.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Range of motion of both knees
Participant's measurements of function will be measured by Range of motion of both knees.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
6 Minute Walk Test (6MWT)
Participants' distance traveled in the span of 6 minutes will be measured on a treadmill (unit: total meters).
Measured: At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.
Activity Count
Participants' activity count will be measured using a fitness tracker (ActiGraph) worn around the ankle. The total time the fitness tracker is worn will be monitored by the device.
Measured: From enrolment to the 12-week study visit.
Knee Injury and Osteoarthritis Score (KOOS)
Participants will be asked to complete the Knee Injury and Osteoarthritis Score (KOOS) questionnaire to measure their overall well-being.
KOOS uses a Likert scale ranging from 0 (No problems) to 4 (Extreme problems).
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
20-Item Short Form Survey (SF-20)
Participants will be asked to complete the 20-Item Short Form Survey Instrument (SF-20) questionnaire which measures their overall well-being including their physical and social functioning.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Tegner Activity Scale
Participants will be asked to complete the Tegner Activity Scale questionnaire, which measures their level of activity.
A 11-point scale (ranging from 0 - 10) is used where a higher score indicates higher level of activity.
Measured: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start31 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. David Wasserstein
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor-investigator, Dr. David Wasserstein, Sunnybrook Health Sciences Centre
- Investigators
- Dr. David Wasserstein, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036003
- Sponsor's protocol ID
- 6427
- Acronym
- KORR
- Status last verified
- Dec 2025
- First submitted
- 30 May 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Sharing Statement: All data relevant to the study will be included in the final study manuscript or uploaded as supplementary information. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PubMed 14613558Barake M, Klibanski A, Tritos NA. Effects of recombinant human growth hormone therapy on bone mineral density in adults with growth hormone deficiency: a meta-analysis. J Clin Endocrinol Metab. 2014 Mar;99(3):852-60. doi: 10.1210/jc.2013-3921. Epub 2014 Jan 1.
PubMed 24423364Yeo AL, Levy D, Martin FC, Sonksen P, Sturgess I, Wheeler MM, Young A. Frailty and the biochemical effects of recombinant human growth hormone in women after surgery for hip fracture. Growth Horm IGF Res. 2003 Dec;13(6):361-70. doi: 10.1016/j.ghir.2003.08.001.
PubMed 14624771Tavares AB, Micmacher E, Biesek S, Assumpcao R, Redorat R, Veloso U, Vaisman M, Farinatti PT, Conceicao F. Effects of Growth Hormone Administration on Muscle Strength in Men over 50 Years Old. Int J Endocrinol. 2013;2013:942030. doi: 10.1155/2013/942030. Epub 2013 Dec 8.
PubMed 24382963Rahimzadeh P, Imani F, Faiz SH, Alebouyeh MR, Azad-Ehyaei D, Bahari L, Memarian A, Kim KH. Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. Anesth Pain Med. 2016 Oct 19;6(6):e41719. doi: 10.5812/aapm.41719. eCollection 2016 Dec.
PubMed 28975078Dunn AR. Intra-articular growth hormone injections regrow cartilage, increase motion and reduce pain in 93 per cent. of arthritic ankles. Osteoarthritis Cartilage. 2012;20:S295-S296. doi:10.1016/j.joca.2012.02.512
Yang S, Cao L, Cai S, Yuan J, Wang J. A systematic review of growth hormone for hip fractures. Growth Horm IGF Res. 2012 Jun-Aug;22(3-4):97-101. doi: 10.1016/j.ghir.2012.03.002. Epub 2012 Apr 1.
PubMed 22472350Yarasheski KE, Campbell JA, Smith K, Rennie MJ, Holloszy JO, Bier DM. Effect of growth hormone and resistance exercise on muscle growth in young men. Am J Physiol. 1992 Mar;262(3 Pt 1):E261-7. doi: 10.1152/ajpendo.1992.262.3.E261.
PubMed 1550219Dubiel R, Callender L, Dunklin C, Harper C, Bennett M, Kreber L, Auchus R, Diaz-Arrastia R. Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury. Front Endocrinol (Lausanne). 2018 Sep 10;9:520. doi: 10.3389/fendo.2018.00520. eCollection 2018.
PubMed 30250451Abreu ME, Valiati R, Hubler R, Moraes AN, Antonini F, de Oliveira Hdo C, Pagnoncelli RM. Effect of Recombinant Human Growth Hormone on Osseointegration of Titanium Implants: A Histologic and Biomechanical Study in Rabbits. J Oral Implantol. 2015 Aug;41(4):e102-9. doi: 10.1563/aaid-joi-D-13-00306. Epub 2014 Jun 19.
PubMed 24946138Ehrnberg A, Brosjo O, Laftman P, Nilsson O, Stromberg L. Enhancement of bone formation in rabbits by recombinant human growth hormone. Acta Orthop Scand. 1993 Oct;64(5):562-6. doi: 10.3109/17453679308993693.
PubMed 8237325Raschke MJ, Bail H, Windhagen HJ, Kolbeck SF, Weiler A, Raun K, Kappelgard A, Skiaerbaek C, Haas NP. Recombinant growth hormone accelerates bone regenerate consolidation in distraction osteogenesis. Bone. 1999 Feb;24(2):81-8. doi: 10.1016/s8756-3282(98)00158-6.
PubMed 9951774Kim SB, Kwon DR, Kwak H, Shin YB, Han HJ, Lee JH, Choi SH. Additive effects of intra-articular injection of growth hormone and hyaluronic acid in rabbit model of collagenase-induced osteoarthritis. J Korean Med Sci. 2010 May;25(5):776-80. doi: 10.3346/jkms.2010.25.5.776. Epub 2010 Apr 16.
PubMed 20436717Hao Y, Dai K, Guo L, Wang Y, Tang T. Effects of recombinant human growth hormone (r-hGH) on experimental osteoporotic fracture healing. Chin J Traumatol. 2001 May;4(2):102-5.
PubMed 11834155Lubis AMT, Wijaya MT, Priosoeryanto BP, Saleh RF, Farqani S. Comparison of weekly and single dose intraarticular recombinant human growth hormone injection on cartilage degeneration in osteoarthritic model of white New Zealand rabbits. J Exp Orthop. 2022 Feb 21;9(1):19. doi: 10.1186/s40634-022-00458-y. No abstract available.
PubMed 35190919
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07036003
- Acronym / sponsor ID
- KORR / 6427
- Keywords
- Recombinant Human Growth Hormone, rHGH, Saizen, Knee Osteoarthritis, Knee OA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dr. David WassersteinUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 25 Jun 2025 (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.
The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan.
Participants will be asked to:
- Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.
- Complete questionnaires related to their knee pain and activities of daily living.
- Provide blood tests.
- Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Growth Hormone (rHGH) | Experimental | Drug: Somatropin (recombinant human growth hormone)Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. |
| Bacteriostatic Saline | Placebo comparator | Drug: bacteriostatic saline placeboSelf-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 - 65 years old.
- Diagnosis of isolated knee osteoarthritis for greater than 6 months.
Key exclusion criteria (13 listed)
- Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament repair/reconstruction, or cartilage transplantation. Patients with remote (>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.
- Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative/complex meniscal tears (>6 months from injury) may be included at the investigators' discretion
- Recent (less than 6 months) intra-articular injection into the involved knee.
- High grade ligamentous knee injury.
- Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.
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 |
|---|---|---|
| Somatropin (recombinant human growth hormone)Study participants will deliver Somatropin via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks at a dose of 0.5mg/day per body surface area (0.5mg/m2/day). | Drug | Recombinant Human Growth Hormone (rHGH) |
| bacteriostatic saline placeboStudy participants will deliver bacteriostatic saline via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks in an identical delivery device to the experimental arm. | Drug | Bacteriostatic Saline |
Primary outcome
Feasibility of the medication administration
Time frame: 6 weeks after treatment begins.
Participant adheres to self-administration of injections once daily for 6 weeks.
13 secondary outcomes
Clinical Outcomes: knee extension strength
Time frame: At 6 weeks and 24 months time points after enrolment
Clinical Outcome: knee flexion strength
Time frame: At 24 months after enrolment.
Clinical Outcomes: thigh muscle strength
Time frame: At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.
Clinical Outcomes: Kinematic Gait Analysis
Time frame: At baseline, 6 weeks and 6 months study visits.
Thigh circumference
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Mid-calf circumference
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Abdominal circumference
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Range of motion of both knees
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
6 Minute Walk Test (6MWT)
Time frame: At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.
Activity Count
Time frame: From enrolment to the 12-week study visit.
Knee Injury and Osteoarthritis Score (KOOS)
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
20-Item Short Form Survey (SF-20)
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
Tegner Activity Scale
Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits
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 31 Jul 2026.
- Background: PubMed 14613558Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- Background: PubMed 24423364Barake M, Klibanski A, Tritos NA. Effects of recombinant human growth hormone therapy on bone mineral density in adults with growth hormone deficiency: a meta-analysis. J Clin Endocrinol Metab. 2014 Mar;99(3):852-60. doi: 10.1210/jc.2013-3921. Epub 2014 Jan 1.
- Background: PubMed 14624771Yeo AL, Levy D, Martin FC, Sonksen P, Sturgess I, Wheeler MM, Young A. Frailty and the biochemical effects of recombinant human growth hormone in women after surgery for hip fracture. Growth Horm IGF Res. 2003 Dec;13(6):361-70. doi: 10.1016/j.ghir.2003.08.001.
- Background: PubMed 24382963Tavares AB, Micmacher E, Biesek S, Assumpcao R, Redorat R, Veloso U, Vaisman M, Farinatti PT, Conceicao F. Effects of Growth Hormone Administration on Muscle Strength in Men over 50 Years Old. Int J Endocrinol. 2013;2013:942030. doi: 10.1155/2013/942030. Epub 2013 Dec 8.
- Background: PubMed 28975078Rahimzadeh P, Imani F, Faiz SH, Alebouyeh MR, Azad-Ehyaei D, Bahari L, Memarian A, Kim KH. Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. Anesth Pain Med. 2016 Oct 19;6(6):e41719. doi: 10.5812/aapm.41719. eCollection 2016 Dec.
- BackgroundDunn AR. Intra-articular growth hormone injections regrow cartilage, increase motion and reduce pain in 93 per cent. of arthritic ankles. Osteoarthritis Cartilage. 2012;20:S295-S296. doi:10.1016/j.joca.2012.02.512
- Background: PubMed 22472350Yang S, Cao L, Cai S, Yuan J, Wang J. A systematic review of growth hormone for hip fractures. Growth Horm IGF Res. 2012 Jun-Aug;22(3-4):97-101. doi: 10.1016/j.ghir.2012.03.002. Epub 2012 Apr 1.
- Background: PubMed 1550219Yarasheski KE, Campbell JA, Smith K, Rennie MJ, Holloszy JO, Bier DM. Effect of growth hormone and resistance exercise on muscle growth in young men. Am J Physiol. 1992 Mar;262(3 Pt 1):E261-7. doi: 10.1152/ajpendo.1992.262.3.E261.
- Background: PubMed 30250451Dubiel R, Callender L, Dunklin C, Harper C, Bennett M, Kreber L, Auchus R, Diaz-Arrastia R. Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury. Front Endocrinol (Lausanne). 2018 Sep 10;9:520. doi: 10.3389/fendo.2018.00520. eCollection 2018.
- Background: PubMed 24946138Abreu ME, Valiati R, Hubler R, Moraes AN, Antonini F, de Oliveira Hdo C, Pagnoncelli RM. Effect of Recombinant Human Growth Hormone on Osseointegration of Titanium Implants: A Histologic and Biomechanical Study in Rabbits. J Oral Implantol. 2015 Aug;41(4):e102-9. doi: 10.1563/aaid-joi-D-13-00306. Epub 2014 Jun 19.
- Background: PubMed 8237325Ehrnberg A, Brosjo O, Laftman P, Nilsson O, Stromberg L. Enhancement of bone formation in rabbits by recombinant human growth hormone. Acta Orthop Scand. 1993 Oct;64(5):562-6. doi: 10.3109/17453679308993693.
- Background: PubMed 9951774Raschke MJ, Bail H, Windhagen HJ, Kolbeck SF, Weiler A, Raun K, Kappelgard A, Skiaerbaek C, Haas NP. Recombinant growth hormone accelerates bone regenerate consolidation in distraction osteogenesis. Bone. 1999 Feb;24(2):81-8. doi: 10.1016/s8756-3282(98)00158-6.
- Saizen Drug Monograph. Accessed October 15, 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data Sharing Statement: All data relevant to the study will be included in the final study manuscript or uploaded as supplementary information. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Dr. David Wasserstein principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Somatropin (recombinant human growth hormone) in people with Knee Osteoarthritis (Knee OA) and Knee Osteoarthritis (OA), run by Dr. David Wasserstein at 1 site in Canada.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
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?
Feasibility of the medication administration (time frame: 6 weeks after treatment begins.). 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 NCT07036003, which also lists 36 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 31 Jul 2026.