search
Back to results

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

Primary Purpose

Humeral Fracture

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fracture focused on measuring Teriparatide, fracture healing, proximal humeral fractures

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Lasarettet i Motala
  • Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Proximal humeral fracture - intervention

Proximal humeral fracture

Arm Description

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

20 patients will receive standard treatment (physiotherapy)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2010
Last Updated
December 9, 2014
Sponsor
University Hospital, Linkoeping
search

1. Study Identification

Unique Protocol Identification Number
NCT01105832
Brief Title
Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
Official Title
Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fracture
Keywords
Teriparatide, fracture healing, proximal humeral fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proximal humeral fracture - intervention
Arm Type
Experimental
Arm Description
20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)
Arm Title
Proximal humeral fracture
Arm Type
No Intervention
Arm Description
20 patients will receive standard treatment (physiotherapy)
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Intervention Description
Teriparatide (Forsteo) 20 micrograms daily during four weeks
Primary Outcome Measure Information:
Title
Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Function
Description
The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group
Time Frame
7 weeks and 3 months
Title
Pain
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
Time Frame
7 weeks and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Lasarettet i Motala
City
Motala
Country
Sweden
Facility Name
Department of Orthopaedics
City
Norrköping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19594305
Citation
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.
Results Reference
result
PubMed Identifier
20367417
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.
Results Reference
result
PubMed Identifier
26179771
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs