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

Phase 4

Completed

• Conditions: Humeral Fracture
• Interventions: Drug: Teriparatide

• Registration Number: NCT01105832
• Lead Sponsor: University Hospital, Linkoeping

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 Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-19
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proximal humeral fracture - intervention	Teriparatide	20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)

Primary Outcome Measures

Name	Time	Method
Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment	7 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Lasarettet i Motala; 🇸🇪 Motala, Sweden

Department of Orthopaedics; 🇸🇪 Norrköping, Sweden