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

NCT ID: NCT01105832

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Humeral Fracture

Keywords

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Teriparatide fracture healing proximal humeral fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Proximal humeral fracture - intervention

20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

Teriparatide (Forsteo) 20 micrograms daily during four weeks

Proximal humeral fracture

20 patients will receive standard treatment (physiotherapy)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Teriparatide

Teriparatide (Forsteo) 20 micrograms daily during four weeks

Intervention Type DRUG

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)
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Torsten Johansson

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lasarettet i Motala

Motala, , Sweden

Site Status

Department of Orthopaedics

Norrköping, , Sweden

Site Status

Countries

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Sweden

References

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Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez 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-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.

Reference Type RESULT
PMID: 19594305 (View on PubMed)

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.

Reference Type RESULT
PMID: 20367417 (View on PubMed)

Johansson T. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients. Acta Orthop. 2016 Feb;87(1):79-82. doi: 10.3109/17453674.2015.1073050. Epub 2015 Jul 15.

Reference Type DERIVED
PMID: 26179771 (View on PubMed)

Other Identifiers

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2009-017320-29

Identifier Type: -

Identifier Source: org_study_id