Bone anchored femoral amputation prostheses - Denusomab Trial

Osseointegrated transdermal femoral amputation prostheses - Denusomab Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003574-66-DK

Enrollment

Registered

2013-01-04

Start date

2013-01-04

Completion date

Unknown

Last updated

2018-01-08

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

Conditions

leg amputee MedDRA version: 16.0 Level: PT Classification code 10024124 Term: Leg amputation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Prolia Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent, Age 18-70 years, candidate for the OI-prosthesis (eg after traumatic amputation or because of tumor), BMI =65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: Diabetes or metabolic disease, atherosclerosis, smoking, drug abuse, treatment with NSAIDs or active treatment with cytotoxic drugs, active cancer, liver or renal impairment, dementia, pregnancy, decreased hip movement on the affected side> 10 degrees, body weight> 100 kg.

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the possibility to optimize patients' rehabilitation progress through the assessment of BMD at the OI-prosthesis and prescription of denusomab H1: BMD increases in the group Denusomab (DXA) compared to controls.;Secondary Objective: H2: Improved prosthetic fixation (RSA) in Denusomab group. H3: Better early mobilization (up to 1 year) H4: bone activity increases within three days post-operative;Primary end point(s): 1.BMD measured pre-and postoperative in the lumbar spine and bilaterally in the femoral neck prosthesis with DXA (primary endpoint).;Timepoint(s) of evaluation of this end point: First patient, first visit february 2013. Last patient last visit february 2016	—

Measure

Time frame

Main Objective: Investigate the possibility to optimize patients' rehabilitation progress through the assessment of BMD at the OI-prosthesis and prescription of denusomab H1: BMD increases in the group Denusomab (DXA) compared to controls.;Secondary Objective: H2: Improved prosthetic fixation (RSA) in Denusomab group. H3: Better early mobilization (up to 1 year) H4: bone activity increases within three days post-operative;Primary end point(s): 1.BMD measured pre-and postoperative in the lumbar spine and bilaterally in the femoral neck prosthesis with DXA (primary endpoint).;Timepoint(s) of evaluation of this end point: First patient, first visit february 2013. Last patient last visit february 2016

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Secondary

Measure	Time frame
Secondary end point(s): 2.Stability (security parameter, a secondary endpoint) studied using stereo x-ray analysis (RSA). 3. Oxygen consumption and gait velocity tested with gait analysis. 4.Postoperative cell activity (CTX (resorption) and PINP and BASP (formation) and OPG and RANKL) and growth factors monitored by collecting samples via microdialysis catheter;Timepoint(s) of evaluation of this end point: First patient, first visit february 2013. Last patient last visit february 2016	—

Measure

Time frame

Secondary end point(s): 2.Stability (security parameter, a secondary endpoint) studied using stereo x-ray analysis (RSA). 3. Oxygen consumption and gait velocity tested with gait analysis. 4.Postoperative cell activity (CTX (resorption) and PINP and BASP (formation) and OPG and RANKL) and growth factors monitored by collecting samples via microdialysis catheter;Timepoint(s) of evaluation of this end point: First patient, first visit february 2013. Last patient last visit february 2016

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Countries

Denmark

Contacts

Public ContactRehne Hansen

Ortopædkirurgisk Forskning

00457846 7471

Outcome results

None listed

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