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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT01105832 (opens ClinicalTrials.gov in a new tab)Other id2009-017320-29Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
University Hospital, Linkoeping · Other
Design
Randomized · Single masking
Countries
1 country

Sweden

Start
Apr 2010
Primary completion
Feb 2014
Completion
Sept 2014
First posted
19 Apr 2010 (estimated)
Last update posted
10 Dec 2014 (estimated)
Conditions
Humeral Fracture

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012201320142015
  1. Ph 4

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

    NCT01105832

    Apr 2010 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug

Arms2

  • Experimental

    Proximal humeral fracture - intervention

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

  • No intervention

    Proximal humeral fracture

    20 patients will receive standard treatment (physiotherapy)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment

    Time frame · 7 weeks

Secondary outcomes(2)

  1. Function

    Time frame · 7 weeks and 3 months

    Registry description

    The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group

  2. Pain

    Time frame · 7 weeks and 3 months

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

4 results

PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients.

Johansson et al. 2016Acta orthopaedicacited by 41

PMID 26179771PMC4940597DOI 10.3109/17453674.2015.1073050PUB-26179771

Free to read · publisher termsCC BY-NC-ND4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2010

3 results

Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.

Aspenberg et al. 2010Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 368

PMID 19594305DOI 10.1359/jbmr.090731PUB-19594305

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2010

Corrected

Teriparatide improves early callus formation in distal radial fractures.

Aspenberg et al. 2010Acta orthopaedicacited by 99

PMID 20367417PMC2895344DOI 10.3109/17453671003761946PUB-20367417

CC BY
Download PDFRead the notice

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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