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Clinical Trials/EUCTR2012-003574-66-DK
EUCTR2012-003574-66-DK
Active, Not Recruiting
Phase 1

Osseointegrated transdermal femoral amputation prostheses - Denusomab Trial

Ortopædkirurgisk Forskning - Aarhus Universitetshospita0 sites14 target enrollmentJanuary 4, 2013
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DrugsProlia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Ortopædkirurgisk Forskning - Aarhus Universitetshospita
Enrollment
14
Status
Active, Not Recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 4, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Ortopædkirurgisk Forskning - Aarhus Universitetshospita

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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