Does postoperative treatment with parathyroidea hormone Forteo®improve the disability inelderly patients undergoing spinal stabilization fusion surgery comparedwith patients treated with placebo. If that is the case, is there a correlationbetween improvement of disability and solid osseous healing?
- Conditions
- Spinal stenosisMedDRA version: 14.1Level: LLTClassification code 10041597Term: Spinal stenosis of lumbar regionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-006152-36-DK
- Lead Sponsor
- Middelfart Rygsektor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Spinal stenosis verified by MRI
Age 60 or above
No diagnosed dementia
(MMSE 24 of 30 correct answers)
Considerable reduction in walking distance which
has not improved during conservative treatment
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
Contraindication for PTH treatment
Major deformity
Mental illness
Spinal cord compression due to infection or
malignant disease
Resent spinal fracture
hypercalcemia
Reduced kidney function
Metabolic bone disease, including
hypophosphatemia
Untreated anti coagulant treatment
Previous radiation therapy
Haematological disorders
Previously fusion spinal surgery
Age under 60
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method