Humeral Fracture
Conditions
Keywords
Teriparatide, fracture healing, proximal humeral fractures
Brief summary
40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS). Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups. The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.
Interventions
DRUGTeriparatide
Teriparatide (Forsteo) 20 micrograms daily during four weeks
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* proximal humeral fracture * postmenopausal woman 50 years or older * non-surgical treatment
Exclusion criteria
* dementia or psychiatric disorder * known malignancy \< 5 years prior to fracture * calcium above reference value * signs of liver disease * creatinine over ref. value * inflammatory joint disease * alcohol or drug abuse * oral corticosteroid medication * long-term NSAID-treatment (=\> 3 months prior to fracture)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment | 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function | 7 weeks and 3 months | The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group |
| Pain | 7 weeks and 3 months | Pain at rest and during activity will be measured using a visual analogue scale (VAS). The experimental group will be compared with the control group |
Countries
Sweden
Outcome results
None listed