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

University Hospital, Linkoeping

Status and phase: Completed; Phase 4

Conditions: Humeral Fracture

Treatments: Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT01105832

2009-017320-29

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 50+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Proximal humeral fracture - intervention

Experimental group

Description:

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

Treatment:

Drug: Teriparatide

Proximal humeral fracture

No Intervention group

Description:

20 patients will receive standard treatment (physiotherapy)