Treatment With PTH After Sternotomy in Cardiac Surgery Patients

NCT01466829 | Completed Phase 3 DMC

• 2 other identifiers: 2011/3862011-004465-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study is to compare healing time and quality of newly formed bone in cardiac surgery patients treated with PTH post-surgically and a control group treated with saline.

Conditions

Disruption or Dehiscence of Closure of Sternum or Sternotomy

Keywords

sternotomy; parathyroid hormone; bone healing

Outcome Measures

Primary Outcomes (1)

• Computer Tomography

  Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.

  6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)

Secondary Outcomes (2)

• Questionnaires

  Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)

• Journal parameters

  Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)

Study Arms (2)

Control

PLACEBO COMPARATOR

Control patients treated with placebo.

Drug: Placebo

Intervention

ACTIVE COMPARATOR

Daily injection with Parathyroid hormone

Drug: Parathyroid hormone

Interventions

Parathyroid hormone DRUG

100 microgram daily. S.c

Also known as: Preotact®

Intervention

Placebo DRUG

Placebo; saline injection.

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full sternotomy
• Not in chronic, systemic corticosteroid treatment.
• No Plavix treatment 5 days prior to surgery
• No known bone metabolic diseases.
• Replete vitamin D status (plasma 25-hydroxyvitamin D \>50 nmol/l)
• Normal serum levels of Calcium, Phosphate, inorganic, alkaline phosphatase (within reference interval).
• No known risk of osteosarcoma.
• Ability to understand and cooperate with the planned examinations.
• Ability to speak and understand Danish.

You may not qualify if:

• Re-operation
• Use of bone wax during surgery
• Prior radiation therapy involving the skeleton
• Severely impaired renal function.
• Known allergic reactions to any of the compounds in the trial medication.
• Current treatment with digoxin
• Major medical or social problems that will be likely to preclude participation
• Severely impaired lever function
• Unknown raised levels of bone specific alkaline phosphatase.

Sponsors & Collaborators

• University of Aarhus: lead
• Takeda: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

MeSH Terms

Interventions

Parathyroid Hormone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Per Nielsen, MD

  Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 8, 2011
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2013-08

Locations

DK (1)