Clinical Trial: Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?
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.
Detailed Summary:
Sponsor: University Hospital, Linkoeping
Current Primary Outcome: Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment [ Time Frame: 7 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Function [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome: Same as current
Information By: University Hospital, Linkoeping
Dates:
Date Received: April 13, 2010
Date Started: April 2010
Date Completion:
Last Updated: December 9, 2014
Last Verified: December 2014
