NCT07036003进行中（未招募）1 期
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial
Dr. David Wasserstein1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Feasibility of the medication administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 - 65 years old.
- •Diagnosis of isolated knee osteoarthritis for greater than 6 months.
排除标准
- •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
- •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.
研究组 & 干预措施
Bacteriostatic Saline
Placebo Comparator
Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.
干预措施: bacteriostatic saline placebo (Drug)
Recombinant Human Growth Hormone (rHGH)
Experimental
Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.
干预措施: Somatropin (recombinant human growth hormone) (Drug)
结局指标
主要结局
Feasibility of the medication administration
时间窗: 6 weeks after treatment begins.
Participant adheres to self-administration of injections once daily for 6 weeks.
次要结局
- Clinical Outcomes: Kinematic Gait Analysis(At baseline, 6 weeks and 6 months study visits.)
- Knee Injury and Osteoarthritis Score (KOOS)(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- 20-Item Short Form Survey (SF-20)(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Tegner Activity Scale(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Thigh circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Clinical Outcomes: thigh muscle strength(At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.)
- Mid-calf circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Abdominal circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Range of motion of both knees(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Clinical Outcomes: knee extension strength(At 6 weeks and 24 months time points after enrolment)
- Clinical Outcome: knee flexion strength(At 24 months after enrolment.)
- Clinical Outcomes: thigh muscle strength(At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.)
- Clinical Outcomes: Kinematic Gait Analysis(At baseline, 6 weeks and 6 months study visits.)
- Thigh circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Mid-calf circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Abdominal circumference(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Range of motion of both knees(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- 6 Minute Walk Test (6MWT)(At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.)
- Activity Count(From enrolment to the 12-week study visit.)
- Knee Injury and Osteoarthritis Score (KOOS)(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- 20-Item Short Form Survey (SF-20)(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
- Tegner Activity Scale(At baseline, 6 weeks, 3, 6, 12 and 24 months study visits)
研究者
Dr. David Wasserstein
Assistant Professor - University of Toronto; Associate Scientist - Sunnybrook Research Institute
Sunnybrook Health Sciences Centre
研究点 (1)
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