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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Torsten Johansson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01105832
First received: April 13, 2010
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Humeral Fracture
 Drug: Teriparatide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function [ Time Frame: 7 weeks and 3 months ] [ Designated as safety issue: No ]
    The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group

  • Pain [ Time Frame: 7 weeks and 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105832

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

Publications:

Responsible Party: Torsten Johansson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01105832     History of Changes
Other Study ID Numbers: 2009-017320-29
Study First Received: April 13, 2010
Last Updated: April 25, 2013
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013