Shoulder Fractures, Trochanteric Fractures
Conditions
Keywords
Fracture, Osteoporosis, Forsteo, Teriparatide, Fracture healing
Brief summary
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
Interventions
DRUGrhPTH(1-34)
Injection of 20 micrograms per day in eight weeks
Sponsors
The Danish Medical Research Council
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute new osteoporotic trochanteric or collum chirurgicum fracture * Postmenopause
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 |
|---|---|
| Radiological evaluation of healing | 0, 4, 8, 12, (16) weeks after fracture |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical bone markers | 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture |
| SF-36 questionnaire | 0, 4, 8, 12, (16) weeks after fracture |
Countries
Denmark
Outcome results
None listed