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The effect of Preotact on the healing of fracture of the upper arm bone.

The effect of 1-84 parathyroidhormone in the treatment of proximal fracture of the humerus. - PTHumerus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005801-54-DK
Enrollment
Unknown
Registered
2012-02-14
Start date
2012-02-22
Completion date
Unknown
Last updated
2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of proximal humerus MedDRA version: 14.1 Level: PT Classification code 10020462 Term: Humerus fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Preotact Product Name: Preotact Pharmaceutical Form: Injection INN or Proposed INN: PARATHYROID HORMONE CAS Number: 9002-64-6 Current Sponsor code: Preotact Other descriptive name: Parathy

Sponsors

Hvidovre Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 65-85 Fracture of the proximal humerus assessed with X-ray that can be treated conservatively. Understand the protocol and what participation involves. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Metabolic bone disease A history with malignant diesase except baso-cellular carcinoma. History with x-ray therapy of the sceleton. Treatment with orally administered antiresorptive medication within the last 3 months. Treatment with intravenously administered bisphosphonates within the last 12 months. Treatment with denusomab within the last 6 months. Pathological fracture. Glumerular filtration rate 1.40 mmol/l Pregnancy Allergy to study medication

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the value of treatment with Preotact in patients with humerus fracture.;Secondary Objective: To assess the healing of humerus with x-ray. ;Primary end point(s): Constant shoulder score.;Timepoint(s) of evaluation of this end point: Week 0, 5, 8, 11, 25, 103.—

Secondary

MeasureTime frame
Secondary end point(s): X-ray of the shoulder. 25-hydroxy vitamin D. Bone markers (CTx, P1NP). Quality of Life (SF-12). Bone mineral density at hip at lumbar site. Grip strength. ;Timepoint(s) of evaluation of this end point: Week 0, 5, 8, 11, 25, 103.—

Countries

Denmark

Contacts

Public ContactUlrich Bang

Hvidovre Hospital

ulrichbangbang@gmail.com4538622124

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026