NCT02091492

Brief Summary

This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

March 13, 2014

Last Update Submit

September 16, 2015

Conditions

Osteoporosis, Age-RelatedHumeral Fractures

Keywords

Proximal humerus fracture, teriparatide

Outcome Measures

Primary Outcomes (1)

  • Identification of bone and callus patterns in the CT data at the fracture site

    As a basis for change quantification, we will identify 3D micro-architecture patterns that occur in the study CT data. These patterns are either learned based on annotated examples, manual segmentation of specific regions in a number of reference examples, or in a data-driven fashion (computer based identification of pattern classes).

    12 weeks

Secondary Outcomes (1)

  • Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data

    12 weeks

Other Outcomes (1)

  • Tracking geometry during bone healing

    12 weeks

Study Arms (2)

Teriparatide

ACTIVE COMPARATOR

Teriparatide 20µg daily subcutaneous injection for 12 weeks after proximal humerus fracture

Drug: Teriparatide

Placebo-Teriparatide

PLACEBO COMPARATOR

Placebo-Teriparatide 20 µg daily subcutaneous injection for 12 weeks after proximal humerus fracture

Drug: Placebo

Interventions

TeriparatideDRUG

Teriparatide 20 µg sc (subcutaneous injection) each day for 12 weeks

Also known as: Forteo
Teriparatide
PlaceboDRUG

Placebo teriparatide sc (subcutaneous injection) each day for 12 weeks

Placebo-Teriparatide

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recent proximal 2-segment humerus fracture (0-8 days post fracture)
  • no surgical treatment at fractured site
  • signed informed consent
  • postmenopausal female and male patients aged 60 - 85 years
  • established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip

You may not qualify if:

  • Hypersensitivity to the active substance or to any of the excipients.
  • Pre-existing hypercalcemia
  • Severe renal impairment (eGFR\< 35ml/min)
  • Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
  • Unexplained elevations of alkaline phosphatase
  • Prior external beam or implant radiation therapy to the skeleton
  • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
  • any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
  • any prior strontium ranelate therapy
  • any prior TPTD of PTH 1-84 therapy
  • malignancies ≤ 5 years except basalioma
  • hypo-/hypercalcemia
  • baseline 25-OH vitamin D3 level ≤10 ng/ml
  • prosthesis at fractured and contralateral humerus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna; St. Vincent Hospital

Vienna, Vienna, 1060, Austria

Location

Related Publications (1)

  • Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.

    PMID: 20367417BACKGROUND

MeSH Terms

Conditions

OsteoporosisHumeral Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Christian Muschitz, M.D.

    Medical University Vienna, St. Vincent Hospital Vienna, Austria

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant for Internal Medicine

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 19, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

AU(1)