A Phase 3 interventional study of Core decompression/PREOB® implantation and Core decompression/placebo implantation in Osteonecrosis of the Femoral Head, sponsored by Bone Therapeutics S.A. Terminated. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Bone Therapeutics S.A · Phase 3, Interventional, and Treatment
Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.
The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.
Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou \& Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.
This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease.
25 studies on the registry are indexed under Legg-Calve-Perthes Disease; 7 are open to participants now.
This study's enrollment of 68 is above the median of 30 across 15 interventional studies indexed under Legg-Calve-Perthes Disease.
Browse Legg-Calve-Perthes Disease studies →Bone Therapeutics S.A is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of Osteonecrosis:
Exclusion Criteria:
Current symptoms and/or signs related to the disease under study
Safety aspects concerning female patients of
Other exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Core decompression/PREOB® implantation
Drug: Core decompression/placebo implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
Percentage of Treatment Responders
A patient was considered as having responded to treatment if: * the WOMAC VA3.1 pain subscale score (Western Ontario and McMaster Universitie Visual Analogue scale) of the study treated hip improved from baseline by at leat the MCID (minimal clinically important difference ) the WOMAC VA3.1 pain subscale score is Visual score based on 10 cm and * the study treated hip did not progress to fractural stages (ARCO III or higher) as assessed by conventional X-ray
Time frame: 24 months
| Milestone | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| Started | 35 | 33 |
| Completed | 35 | 33 |
| Not completed | 0 | 0 |
| Milestone | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| Started | 35 | 33 |
| Completed | 34 | 30 |
| Not completed | 1 | 3 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| Started | 34 | 30 |
| Completed | 25 | 29 |
| Not completed | 9 | 1 |
| Withdrew: Adverse event | 6 | 0 |
| Withdrew: Other | 3 | 1 |
| Milestone | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| Started | 25 | 29 |
| Completed | 23 | 26 |
| Not completed | 2 | 3 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
A patient was considered as having responded to treatment if: * the WOMAC VA3.1 pain subscale score (Western Ontario and McMaster Universitie Visual Analogue scale) of the study treated hip improved from baseline by at leat the MCID (minimal clinically important difference ) the WOMAC VA3.1 pain subscale score is Visual score based on 10 cm and * the study treated hip did not progress to fractural stages (ARCO III or higher) as assessed by conventional X-ray
| percentage of treatment responders | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| Percentage of Treatment Responders | 60.9 (38.5 to 80.3) | 69.2 (48.2 to 85.7) |
Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core Decompression/PREOB® Implantation | 0/25 (0%) | 16/25 (64%) | 22/25 (88%) |
| Core Decompression/Placebo Implantation | 0/29 (0%) | 18/29 (62.1%) | 25/29 (86.2%) |
| Event | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| disease progressionGeneral disorders | 7/25 | 14/29 |
| Colitis ulcerativeGastrointestinal disorders | 2/25 | 0/29 |
| FallInjury, poisoning and procedural complications | 1/25 | 1/29 |
| Chest painGeneral disorders | 1/25 | 1/29 |
| DiarrhoeaGastrointestinal disorders | 1/25 | 0/29 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/25 | 0/29 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 1/25 | 0/29 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/25 | 0/29 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 1/25 | 0/29 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/25 | 0/29 |
| Event | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/25 | 13/29 |
| NasopharyngitisInfections and infestations | 4/25 | 1/29 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 3/25 | 1/29 |
| Microcytic anaemiaBlood and lymphatic system disorders | 3/25 | 0/29 |
| TendonitisMusculoskeletal and connective tissue disorders | 0/25 | 3/29 |
| InsomniaPsychiatric disorders | 2/25 | 1/29 |
| Back painMusculoskeletal and connective tissue disorders | 1/25 | 2/29 |
| Joint swellingMusculoskeletal and connective tissue disorders | 1/25 | 2/29 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/25 | 2/29 |
| PainGeneral disorders | 1/25 | 2/29 |
| Age, Continuous(years) | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation | Total |
|---|---|---|---|
| Mean | 46.4 ± 9.9 | 45.4 ± 9.7 | 45.9 ± 9.7 |
| Sex: Female, Male(Participants) | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 27 | 26 | 53 |
| Race/Ethnicity, Customized(Participants) | Core Decompression/PREOB® Implantation | Core Decompression/Placebo Implantation | Total |
|---|---|---|---|
| Ethnic origin — Caucasian/White | 30 | 29 | 59 |
| Ethnic origin — Black | 2 | 1 | 3 |
| Ethnic origin — Oriental/Asian | 1 | 0 | 1 |
| Ethnic origin — Hispanic | 0 | 0 | 0 |
| Ethnic origin — Other | 1 | 0 | 1 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Bone Therapeutics S.A