Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?|
- Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- Function [ Time Frame: 7 weeks and 3 months ] [ Designated as safety issue: No ]The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group
- Pain [ Time Frame: 7 weeks and 3 months ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Proximal humeral fracture - intervention
20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)
Teriparatide (Forsteo) 20 micrograms daily during four weeks
No Intervention: Proximal humeral fracture
20 patients will receive standard treatment (physiotherapy)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105832
|Lasarettet i Motala|
|Department of Orthopaedics|