Cancer of BoneNCT06720142
Mg OSTEOCRETE Post-Treatment Outcomes
An observational study of Cancer of Bone and Trauma, run by Santiago Lozano-Calderon at 1 site in United States.
Trial summary
Mg OSTEOCRETE is a bone substitute used to fill a defect in bone caused by excision of a tumor, orthopaedic hardware that has become loosened, or a trauma-related condition. The aim of this study is to determine the amount of time it takes for bone to heal after treatment with Mg OSTEOCRETE, and to better understand… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Bone, Trauma, Aseptic Loosening of Orthopaedic Hardware
- What is being tested?
- Mg OSTEOCRETE as a bone void filler
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 17 Mar 2028
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients who are 18 years or older and receive Mg OSTEOCRETE™ as bone void filler as a component of their treatment.
Who may be able to join
- 18 years of age and older on the day of surgery
- has received or will receive Mg OSTEOCRETE as a component of their treatment at this institution in accordance with Instructions for Use for the implanted product
- Mg OSTEOCRETE is indicated for one of the following reasons:
- as a bone void filler following bone tumor resection, or;
- as an augment for defects causing aseptic loosening of orthopaedic implants, or;
- to help substitute bone for trauma-related conditions
Who cannot join
- any contraindication as per Instructions for Use for Mg OSTEOCRETE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Santiago A Lozano-Calderon, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Shreya Halur, BS, 617-726-4932, shalur@mgh.harvard.edu
About this study
Official title: Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE
Mg OSTEOCRETE is a bone substitute used to fill a defect in bone caused by excision of a tumor, orthopaedic hardware that has become loosened, or a trauma-related condition. The aim of this study is to determine the amount of time it takes for bone to heal after treatment with Mg OSTEOCRETE, and to better understand the efficacy of this treatment through clinical and patient-reported outcomes.
Read the detailed description
Bone voids in the skeletal system can result from trauma, infection, surgery, or oncologic disease. If these voids are not treated, they may lead to issues such as pathological fractures, treatment or hardware failure, and recurrence of disease. Various methods exist for addressing bone voids, primarily through the use of grafting materials. Autograft-bone harvested from another part of the same patient and transplanted into the void-is considered the "gold standard" because they fulfill all three criteria of the "ideal" void filler: they are osteoconductive, osteoinductive, and osteogenic. However, their use can be limited by availability and potential donor site complications, with up to 39% of patients reporting pain at the donor site.
Due to concerns with traditional bone grafting methods, there is growing interest in alternative options. While allografts carry a risk of disease transmission and xenografts are prone to immune rejection, synthetic bone graft substitutes offer a promising alternative. These substitutes, made from materials like calcium sulfate or calcium phosphate, address many issues associated with autografts and allografts. With improved understanding of their performance post-implantation, ongoing advancements are being made. This Clinical Investigation Plan outlines an observational study to evaluate clinical and radiographic outcomes with a particular synthetic bone graft substitute (Mg OSTEOCRETE™; Alliant Biotech, LLC; Grand Rapids, MI).
Mg OSTEOCRETE™ is a moldable/injectable magnesium-based void filler that provides stability while also increasing cell proliferation. Use of Mg OSTEOCRETE™ has been shown to advance the rate of mineralization with a result of enhanced bone regeneration for multiple types of orthopedic applications.
- Being tested
- Mg OSTEOCRETE as a bone void filler
- Keywords
- bone defect, bone substitute, osteocrete
- Medical subject headings
- Bone Neoplasms, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mg OSTEOCRETE as a bone void fillerDevice
Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by bone tumor resection
Mg OSTEOCRETE as a bone void fillerDevice
Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by aseptic loosening of orthopaedic hardware
Mg OSTEOCRETE as a bone void fillerDevice
Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by trauma-related conditions
| Study group | Role | What they receive |
|---|---|---|
| Bone void following bone tumor resection | Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. Receives: Device: Mg OSTEOCRETE as a bone void filler | |
| Bone defect caused by aseptic loosening of orthopaedic implants | Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. Receives: Device: Mg OSTEOCRETE as a bone void filler | |
| Bone defect caused by trauma-related condition | Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. Receives: Device: Mg OSTEOCRETE as a bone void filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete bone remodeling
To determine the time to complete bone remodeling after injection of a magnesium-based bone graft substitute (Mg OSTEOCRETE™), as determined by Hounsfield Units on computed tomography (CT) scan.
Measured: Pre-operatively through one year after surgery
Secondary outcomes (1)
Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE
To collect safety and efficacy data regarding the performance of Mg OSTEOCRETE™. To longitudinally assess the patient-reported clinical outcomes after injection of a magnesium-based bone graft substitute (Mg OSTEOCRETE™).
Measured: Pre-operatively through one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start17 Mar 2025
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cancer of BoneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santiago Lozano-Calderon
- Sponsor type
- University, hospital or other
- Collaborators
- Bone Solutions Inc
- Responsible party
- Sponsor-investigator, Santiago Lozano-Calderon, Massachusetts General Hospital
- Investigators
- Santiago A Lozano-Calderon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720142
- Sponsor's protocol ID
- 2024P003397
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wu F, Wei J, Guo H, Chen F, Hong H, Liu C. Self-setting bioactive calcium-magnesium phosphate cement with high strength and degradability for bone regeneration. Acta Biomater. 2008 Nov;4(6):1873-84. doi: 10.1016/j.actbio.2008.06.020. Epub 2008 Jul 10.
PubMed 18662897Zhang Z., Yang Z., Chen Z., et al. A study on bone cement containing magnesium potassium phosphate for bone repair. Cogent Biol 2018;4(1):1487255. Doi: 10.1080/23312025.2018.1487255.
Waselau M, Samii VF, Weisbrode SE, Litsky AS, Bertone AL. Effects of a magnesium adhesive cement on bone stability and healing following a metatarsal osteotomy in horses. Am J Vet Res. 2007 Apr;68(4):370-8. doi: 10.2460/ajvr.68.4.370.
PubMed 17397291Gulotta LV, Kovacevic D, Ying L, Ehteshami JR, Montgomery S, Rodeo SA. Augmentation of tendon-to-bone healing with a magnesium-based bone adhesive. Am J Sports Med. 2008 Jul;36(7):1290-7. doi: 10.1177/0363546508314396. Epub 2008 Mar 4.
PubMed 18319348Yoshizawa S, Brown A, Barchowsky A, Sfeir C. Magnesium ion stimulation of bone marrow stromal cells enhances osteogenic activity, simulating the effect of magnesium alloy degradation. Acta Biomater. 2014 Jun;10(6):2834-42. doi: 10.1016/j.actbio.2014.02.002. Epub 2014 Feb 7.
PubMed 24512978Diaz-Tocados JM, Herencia C, Martinez-Moreno JM, Montes de Oca A, Rodriguez-Ortiz ME, Vergara N, Blanco A, Steppan S, Almaden Y, Rodriguez M, Munoz-Castaneda JR. Magnesium Chloride promotes Osteogenesis through Notch signaling activation and expansion of Mesenchymal Stem Cells. Sci Rep. 2017 Aug 10;7(1):7839. doi: 10.1038/s41598-017-08379-y.
PubMed 28798480Pernaa K, Koski I, Mattila K, Gullichsen E, Heikkila J, Aho A, Lindfors N. Bioactive glass S53P4 and autograft bone in treatment of depressed tibial plateau fractures - a prospective randomized 11-year follow-up. J Long Term Eff Med Implants. 2011;21(2):139-48. doi: 10.1615/jlongtermeffmedimplants.v21.i2.40.
PubMed 22043972Russell TA, Leighton RK; Alpha-BSM Tibial Plateau Fracture Study Group. Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study. J Bone Joint Surg Am. 2008 Oct;90(10):2057-61. doi: 10.2106/JBJS.G.01191.
PubMed 18829901Heikkila JT, Kukkonen J, Aho AJ, Moisander S, Kyyronen T, Mattila K. Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study. J Mater Sci Mater Med. 2011 Apr;22(4):1073-80. doi: 10.1007/s10856-011-4272-0. Epub 2011 Mar 23.
PubMed 21431354Hofmann A, Gorbulev S, Guehring T, Schulz AP, Schupfner R, Raschke M, Huber-Wagner S, Rommens PM; CERTiFy Study Group. Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study. J Bone Joint Surg Am. 2020 Feb 5;102(3):179-193. doi: 10.2106/JBJS.19.00680.
PubMed 31809394
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE
- ClinicalTrials.gov ID
- NCT06720142
- Acronym / sponsor ID
- 2024P003397
- Keywords
- bone defect, bone substitute, osteocrete
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Santiago Lozano-CalderonUniversity, hospital or other
- Collaborators
- Bone Solutions Inc
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 6 Dec 2024 (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.
Mg OSTEOCRETE is a bone substitute used to fill a defect in bone caused by excision of a tumor, orthopaedic hardware that has become loosened, or a trauma-related condition. The aim of this study is to determine the amount of time it takes for bone to heal after treatment with Mg OSTEOCRETE, and to better understand the efficacy of this treatment through clinical and patient-reported outcomes.
Detailed description
Bone voids in the skeletal system can result from trauma, infection, surgery, or oncologic disease. If these voids are not treated, they may lead to issues such as pathological fractures, treatment or hardware failure, and recurrence of disease. Various methods exist for addressing bone voids, primarily through the use of grafting materials. Autograft-bone harvested from another part of the same patient and transplanted into the void-is considered the "gold standard" because they fulfill all three criteria of the "ideal" void filler: they are osteoconductive, osteoinductive, and osteogenic. However, their use can be limited by availability and potential donor site complications, with up to 39% of patients reporting pain at the donor site.
Due to concerns with traditional bone grafting methods, there is growing interest in alternative options. While allografts carry a risk of disease transmission and xenografts are prone to immune rejection, synthetic bone graft substitutes offer a promising alternative. These substitutes, made from materials like calcium sulfate or calcium phosphate, address many issues associated with autografts and allografts. With improved understanding of their performance post-implantation, ongoing advancements are being made. This Clinical Investigation Plan outlines an observational study to evaluate clinical and radiographic outcomes with a particular synthetic bone graft substitute (Mg OSTEOCRETE™; Alliant Biotech, LLC; Grand Rapids, MI).
Mg OSTEOCRETE™ is a moldable/injectable magnesium-based void filler that provides stability while also increasing cell proliferation. Use of Mg OSTEOCRETE™ has been shown to advance the rate of mineralization with a result of enhanced bone regeneration for multiple types of orthopedic applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bone void following bone tumor resection | – | Device: Mg OSTEOCRETE as a bone void fillerPatients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. |
| Bone defect caused by aseptic loosening of orthopaedic implants | – | Device: Mg OSTEOCRETE as a bone void fillerPatients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. |
| Bone defect caused by trauma-related condition | – | Device: Mg OSTEOCRETE as a bone void fillerPatients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients who are 18 years or older and receive Mg OSTEOCRETE™ as bone void filler as a component of their treatment.
Key inclusion criteria (6 listed)
- 18 years of age and older on the day of surgery
- has received or will receive Mg OSTEOCRETE as a component of their treatment at this institution in accordance with Instructions for Use for the implanted product
- Mg OSTEOCRETE is indicated for one of the following reasons:
Key exclusion criteria (1 listed)
- any contraindication as per Instructions for Use for Mg OSTEOCRETE
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 |
|---|---|---|
| Mg OSTEOCRETE as a bone void fillerPatients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by bone tumor resection | Device | Bone void following bone tumor resection |
| Mg OSTEOCRETE as a bone void fillerPatients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by aseptic loosening of orthopaedic hardware | Device | Bone defect caused by aseptic loosening of orthopaedic implants |
| Mg OSTEOCRETE as a bone void fillerPatients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by trauma-related conditions | Device | Bone defect caused by trauma-related condition |
Primary outcome
Time to complete bone remodeling
Time frame: Pre-operatively through one year after surgery
To determine the time to complete bone remodeling after injection of a magnesium-based bone graft substitute (Mg OSTEOCRETE™), as determined by Hounsfield Units on computed tomography (CT) scan.
1 secondary outcome
Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE
Time frame: Pre-operatively through one year after surgery
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 22 Apr 2026.
- Background: PubMed 18662897Wu F, Wei J, Guo H, Chen F, Hong H, Liu C. Self-setting bioactive calcium-magnesium phosphate cement with high strength and degradability for bone regeneration. Acta Biomater. 2008 Nov;4(6):1873-84. doi: 10.1016/j.actbio.2008.06.020. Epub 2008 Jul 10.
- BackgroundZhang Z., Yang Z., Chen Z., et al. A study on bone cement containing magnesium potassium phosphate for bone repair. Cogent Biol 2018;4(1):1487255. Doi: 10.1080/23312025.2018.1487255.
- Background: PubMed 17397291Waselau M, Samii VF, Weisbrode SE, Litsky AS, Bertone AL. Effects of a magnesium adhesive cement on bone stability and healing following a metatarsal osteotomy in horses. Am J Vet Res. 2007 Apr;68(4):370-8. doi: 10.2460/ajvr.68.4.370.
- Background: PubMed 18319348Gulotta LV, Kovacevic D, Ying L, Ehteshami JR, Montgomery S, Rodeo SA. Augmentation of tendon-to-bone healing with a magnesium-based bone adhesive. Am J Sports Med. 2008 Jul;36(7):1290-7. doi: 10.1177/0363546508314396. Epub 2008 Mar 4.
- Background: PubMed 24512978Yoshizawa S, Brown A, Barchowsky A, Sfeir C. Magnesium ion stimulation of bone marrow stromal cells enhances osteogenic activity, simulating the effect of magnesium alloy degradation. Acta Biomater. 2014 Jun;10(6):2834-42. doi: 10.1016/j.actbio.2014.02.002. Epub 2014 Feb 7.
- Background: PubMed 28798480Diaz-Tocados JM, Herencia C, Martinez-Moreno JM, Montes de Oca A, Rodriguez-Ortiz ME, Vergara N, Blanco A, Steppan S, Almaden Y, Rodriguez M, Munoz-Castaneda JR. Magnesium Chloride promotes Osteogenesis through Notch signaling activation and expansion of Mesenchymal Stem Cells. Sci Rep. 2017 Aug 10;7(1):7839. doi: 10.1038/s41598-017-08379-y.
- Background: PubMed 22043972Pernaa K, Koski I, Mattila K, Gullichsen E, Heikkila J, Aho A, Lindfors N. Bioactive glass S53P4 and autograft bone in treatment of depressed tibial plateau fractures - a prospective randomized 11-year follow-up. J Long Term Eff Med Implants. 2011;21(2):139-48. doi: 10.1615/jlongtermeffmedimplants.v21.i2.40.
- Background: PubMed 18829901Russell TA, Leighton RK; Alpha-BSM Tibial Plateau Fracture Study Group. Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study. J Bone Joint Surg Am. 2008 Oct;90(10):2057-61. doi: 10.2106/JBJS.G.01191.
- Background: PubMed 21431354Heikkila JT, Kukkonen J, Aho AJ, Moisander S, Kyyronen T, Mattila K. Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study. J Mater Sci Mater Med. 2011 Apr;22(4):1073-80. doi: 10.1007/s10856-011-4272-0. Epub 2011 Mar 23.
- Background: PubMed 31809394Hofmann A, Gorbulev S, Guehring T, Schulz AP, Schupfner R, Raschke M, Huber-Wagner S, Rommens PM; CERTiFy Study Group. Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study. J Bone Joint Surg Am. 2020 Feb 5;102(3):179-193. doi: 10.2106/JBJS.19.00680.
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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.
Santiago A Lozano-Calderon, MD, PhD contact
Santiago A Lozano-Calderon, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Bone and Trauma, run by Santiago Lozano-Calderon at 1 site in United States.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Apr 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 United States. 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.
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?
Contact Shreya Halur, BS (617-726-4932, shalur@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete bone remodeling (time frame: Pre-operatively through one year after surgery). 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 NCT06720142, which also lists 10 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 22 Apr 2026.