Bone anchored femoral amputation prostheses - Denusomab Trial

Phase 1

• Conditions: leg amputee; MedDRA version: 16.0Level: PTClassification code 10024124Term: Leg amputationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003574-66-DK
• Lead Sponsor: Ortopædkirurgisk Forskning - Aarhus Universitetshospita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-04
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Informed consent,
Age 18-70 years,
candidate for the OI-prosthesis (eg after traumatic amputation or because of tumor),
BMI <30, normal bone structure except for reduced BMD.
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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified