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Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061995
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Erasme University Hospital

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Severe Osteoporosis Drug: PREOB® Intravenous Infusion Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study
Actual Study Start Date : December 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: PREOB® Intravenous Infusion Drug: PREOB® Intravenous Infusion
Each patient will undergo a single intravenous administration of PREOB®.

Primary Outcome Measures :
  1. Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan [ Time Frame: 72 hours ]
  2. 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 ]

Secondary Outcome Measures :
  1. Pain measured by the Visual Analogue Scale [ Time Frame: 12 months ]
  2. Well-being score using SF-36 questionnaire [ Time Frame: 12 months ]
  3. Occurrence of new vertebral fractures as assessed by X-ray [ Time Frame: 12 months ]
  4. Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA) [ Time Frame: 12 months ]
  5. Measurement of bone formation and resorption markers [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061995

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Investigating site BE01
Anderlecht, Belgium
Sponsors and Collaborators
Erasme University Hospital
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Responsible Party: Erasme University Hospital Identifier: NCT02061995    
Other Study ID Numbers: PREOB-OP1
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: February 2014
Keywords provided by Erasme University Hospital:
Bone Diseases
Metabolic Bone Diseases
Bone Fractures
Osteoporotic Fractures
Musculoskeletal Diseases
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases