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

Information source: University Hospital, Linkoeping
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Humeral Fracture

Intervention: Teriparatide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Linkoeping

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.

Clinical Details

Official title: Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Function

Pain

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

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)

Locations and Contacts

Lasarettet i Motala, Motala, Sweden

Department of Orthopaedics, Norrköping, Sweden

Additional Information

Starting date: April 2010
Last updated: December 9, 2014

Page last updated: August 20, 2015

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