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

Humeral Fracture Clinical Trial

Official title:

Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105832
• Other study ID #: 2009-017320-29
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2010
• Last updated: December 9, 2014
• Start date: April 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture
• Humeral Fractures
• Shoulder Fractures

Intervention

Drug:
• Teriparatide
Teriparatide (Forsteo) 20 micrograms daily during four weeks

Locations

Country	Name	City	State
Sweden	Lasarettet i Motala	Motala
Sweden	Department of Orthopaedics	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, García-Hernández PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-bli — View Citation

Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946. Erratum in: Acta Orthop. 2010 Oct;81(5):647. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment		7 weeks
Secondary	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
Secondary	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