Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?

Study Overview
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Brief Summary
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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.

Official Title
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Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?

Conditions
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Humeral Fracture

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal humeral fracture - intervention<br>20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo) | Drug: Teriparatide<br>* Teriparatide (Forsteo) 20 micrograms daily during four weeks<br>|
| No Intervention: Proximal humeral fracture<br>20 patients will receive standard treatment (physiotherapy) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group | 7 weeks and 3 months | 
| Pain | 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 | 7 weeks and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teriparatide, fracture healing, proximal humeral fractures