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Completed

NCT Number: NCT01105832

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

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.

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Key information

Conditions

Humeral Fracture Arm Injuries Fractures, Bone Humeral Fractures Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lasarettet i Motala, Motala, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Teriparatide

Drug

Teriparatide (Forsteo) 20 micrograms daily during four weeks

Primary outcomes

  1. Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment

    Time frame: 7 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2010
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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