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: FunctionPain
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
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