Severe OsteoporosisPhase 2NCT02061995
Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis
A Phase 2 study testing PREOB® Intravenous Infusion in people with Severe Osteoporosis, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Severe Osteoporosis
- What is being tested?
- PREOB® Intravenous Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe osteoporosis
- Non-response to anti-osteoporotic treatment for over 2 years
- Normal hematology function
- Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
Who cannot join
- Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
- Current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator
- Severe renal or hepatic impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture.
Osteoporosis is one of the most common and debilitating chronic diseases, and a global health concern with a high prevalence not only in Western countries, but also in Asia and Latin America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent. Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of pharmacological treatments, osteoporosis remains a significant health problem for patients who do not respond to the available treatments or fail to comply with their regimens.
The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic patients who do not respond to pharmacological treatments.
- Conditions
- Severe Osteoporosis
- Being tested
- PREOB® Intravenous Infusion
- Keywords
- Bone Diseases, Metabolic Bone Diseases, Osteoporosis, Bone Fractures, Osteoporotic Fractures, Musculoskeletal Diseases
- Medical subject headings
- Osteoporosis, Bone Diseases, Bone Diseases, Metabolic, Fractures, Bone, Osteoporotic Fractures, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREOB® Intravenous InfusionDrug
Each patient will undergo a single intravenous administration of PREOB®.
| Study group | Role | What they receive |
|---|---|---|
| PREOB® Intravenous Infusion | Experimental | Not described Receives: Drug: PREOB® Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan
Measured: 72 hours
Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements
Measured: 12 months
Secondary outcomes (5)
Pain measured by the Visual Analogue Scale
Measured: 12 months
Well-being score using SF-36 questionnaire
Measured: 12 months
Occurrence of new vertebral fractures as assessed by X-ray
Measured: 12 months
Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)
Measured: 12 months
Measurement of bone formation and resorption markers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe OsteoporosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061995
- Sponsor's protocol ID
- PREOB-OP1
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study
- ClinicalTrials.gov ID
- NCT02061995
- Acronym / sponsor ID
- PREOB-OP1
- Conditions
- Severe Osteoporosis
- Keywords
- Bone Diseases, Metabolic Bone Diseases, Osteoporosis, Bone Fractures, Osteoporotic Fractures, Musculoskeletal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Feb 2014 (estimated)
- 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.
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture.
Osteoporosis is one of the most common and debilitating chronic diseases, and a global health concern with a high prevalence not only in Western countries, but also in Asia and Latin America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent. Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of pharmacological treatments, osteoporosis remains a significant health problem for patients who do not respond to the available treatments or fail to comply with their regimens.
The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic patients who do not respond to pharmacological treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREOB® Intravenous Infusion | Experimental | Drug: PREOB® Intravenous Infusion |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of severe osteoporosis
- Non-response to anti-osteoporotic treatment for over 2 years
- Normal hematology function
- Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
Key exclusion criteria (3 listed)
- Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
- Current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator
- Severe renal or hepatic impairment
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 |
|---|---|---|
| PREOB® Intravenous InfusionEach patient will undergo a single intravenous administration of PREOB®. | Drug | PREOB® Intravenous Infusion |
Primary outcome
Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan
Time frame: 72 hours
Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements
Time frame: 12 months
5 secondary outcomes
Pain measured by the Visual Analogue Scale
Time frame: 12 months
Well-being score using SF-36 questionnaire
Time frame: 12 months
Occurrence of new vertebral fractures as assessed by X-ray
Time frame: 12 months
Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)
Time frame: 12 months
Measurement of bone formation and resorption markers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PREOB® Intravenous Infusion in people with Severe Osteoporosis, run by Erasme University Hospital at 1 site in Belgium.
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 3 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 28 Aug 2019. 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 Belgium. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.