pertrocanteric femur fractures or collum humerus fractures in osteoporotic postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10017082 Term: Fracture due to osteoporosis
Conditions
Interventions
Trade Name: Forsteo
Pharmaceutical Form: Injection*
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232674
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration num
Sponsors
Glostrup University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute new osteoporotic hip fracture or collum chirurgicum fracture Age 50-85 years Female Postmenopause 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Calcium metabolic disease other than osteoporosis Diseases known to affect calcium homeostasis Dementia Hypersensitivity to drug or other components of medication Pre-existing hypercalcemia Decreased kidney function Increased alkaline phosphatase Prior external radiation therapy or brachytherapy of the skeleton Skeletal malignancies or bone metastases Alcohol and/or drug abuse Systemic treatment with corticosteroids within the last four weeks Non-cooperating patients Patients who do not speak and understand the Danish language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evaluation of callus formation (callus area) of the fractured bone assessed by x-ray, during and after PTH(1-34)-treatment.;Main Objective: Primary objective of the study is to demonstrate the stimulatory effect of PTH(1-34) on bone healing measured by callus formation (callus area) as determined by x-ray analysis . ;Secondary Objective: The secondary objectives are to determine the effect of PTH(1-34), during fracture healing, on biochemical markers of bone formation (Alkaline phosphatase, s-osteocalcin, s-P1CP) and resorption (s-NTX), bone mineral density (BMD) and bone mineral content (BMC). Furthermore life quality of the patients will be evaluated using SF-36 questionnaire. | — |
Countries
Denmark
Outcome results
None listed