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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01105832
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : December 10, 2014
Information provided by (Responsible Party):
Torsten Johansson, 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.

Condition or disease Intervention/treatment Phase
Humeral Fracture Drug: Teriparatide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?
Study Start Date : April 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Proximal humeral fracture - intervention
20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)
Drug: Teriparatide
Teriparatide (Forsteo) 20 micrograms daily during four weeks
No Intervention: Proximal humeral fracture
20 patients will receive standard treatment (physiotherapy)

Primary Outcome Measures :
  1. Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Function [ Time Frame: 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

  2. Pain [ Time Frame: 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

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01105832

Lasarettet i Motala
Motala, Sweden
Department of Orthopaedics
Norrköping, Sweden
Sponsors and Collaborators
University Hospital, Linkoeping

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Torsten Johansson, MD, PhD, University Hospital, Linkoeping Identifier: NCT01105832     History of Changes
Other Study ID Numbers: 2009-017320-29
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Torsten Johansson, University Hospital, Linkoeping:
fracture healing
proximal humeral fractures

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries
Bone Density Conservation Agents
Physiological Effects of Drugs