Parathyroid Hormone for the Treatment of Humerus Fractures

Shoulder Fractures Clinical Trial

Official title:

Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01687374
• Other study ID #: HvH-2011-545-1
• Status: Recruiting
• Phase: Phase 4
• First received: March 12, 2012
• Last updated: September 13, 2012
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Hvidovre University Hospital
• Contact: Lars Hyldstrup, MDSc
• Email: hyld[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Hypothesis:

The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• proximal humeral fracture eligible for conservative treatment.

• able to understand the protocol

• signs an informed consent

Exclusion Criteria:

• liver disease

• kidney disease

• severe osteoporosis

• malignant disease

• bone metabolic disease

• oral treatment with bisphosphonates during the last 3 months.

• treatment with Denosumab during the last 6 months.

• intravenous treatment with bisphosphonates during the last 12 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Shoulder Fractures

Intervention

Drug:
• 1-84 parathyroid hormone
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
• Placebo
Saline injection daily for 8 weeks.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Takeda

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, García-Hernández PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731. — View Citation

Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in constant score	Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.	5, 8, 11, 23, and 104 weeks.	No
Secondary	Changes in Oxford Shoulder Score	Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.	5, 8, 11, 23, and 104 weeks.	No
Secondary	Changes in bone formation evaluated by X-ray.		5, 8, 11, 23, and 104 weeks.	No
Secondary	Changes in biochemical bone markers	sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.	0, 5, 25 weeks	Yes
Secondary	Changes in regulatory T lymphocytes	Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.	0, 8, 24 weeks	No