Does bisfosfonat preserve the bone volume in transplanted bone in the jaw?

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003817-28-SE

Enrollment

Registered

2015-03-20

Start date

2015-09-21

Completion date

Unknown

Last updated

2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw abnormality

Interventions

Trade Name: Bondronat Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IBANDRONIC ACID CAS Number: 114084-78-5 Concentration unit: µg microgram(s) Concentration type: up

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: At least 18 years old Healthy patients or patients with mild systemic disease (ASA I and II) Jaw abnormality Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient with severe systemic disorder (ASA>III) Patients medicating with systemic bifosfonates Pregnant women (positive pregnancy test) Hypersensitivity agains the substance or any other reagents. Hypocalcemi

Design outcomes

Primary

Measure	Time frame
Main Objective: The volume reduction is 25% less in bone transplant which has received Bondronat compared to bone transplant which has received placebo at 6 month postoperative.;Secondary Objective: 1, Does the bone density of the transplanted bone treated with Bandronate increase between 2 and 26 weeks? 2, Does the transplanted bone treated with bandonate seem to heal better? ;Primary end point(s): The bone voulme measured with Cone Beam Computed Tomography 2 weeks and 26 weeks postoperative by (CBCT) ;Timepoint(s) of evaluation of this end point: 2 weeks postoperative and 26 weeks postoperative	—

Measure

Time frame

Main Objective: The volume reduction is 25% less in bone transplant which has received Bondronat compared to bone transplant which has received placebo at 6 month postoperative.;Secondary Objective: 1, Does the bone density of the transplanted bone treated with Bandronate increase between 2 and 26 weeks? 2, Does the transplanted bone treated with bandonate seem to heal better? ;Primary end point(s): The bone voulme measured with Cone Beam Computed Tomography 2 weeks and 26 weeks postoperative by (CBCT) ;Timepoint(s) of evaluation of this end point: 2 weeks postoperative and 26 weeks postoperative

—

Secondary

Measure	Time frame
Secondary end point(s): 1, The bone density measured by Cone Beam Computed Tomography (CBCT) 2 weeks and 26 weeks postoperative Healaing of the bone tissue will be observed by Clinical examination at whole study period;Timepoint(s) of evaluation of this end point: 1, 2 and 26 weeks postoperative 2, 2weeks, 4 weeks, 8 weeks and 26 weeks.	—

Countries

Sweden

Contacts

Public ContactKäkkliniken

Region Östergötland

jahan.aspenberg@regionostergotland.se00461038551

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026