Parathyroid Hormone for the Treatment of Humerus Fractures
Primary Purpose
Shoulder Fractures
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
1-84 parathyroid hormone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Fractures focused on measuring proximal humeral fracture
Eligibility Criteria
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.
Sites / Locations
- Hvidovre HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Parathyroid hormone
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in Oxford Shoulder Score
Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
Changes in bone formation evaluated by X-ray.
Changes in biochemical bone markers
sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
Changes in regulatory T lymphocytes
Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
Full Information
NCT ID
NCT01687374
First Posted
March 12, 2012
Last Updated
September 13, 2012
Sponsor
Hvidovre University Hospital
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT01687374
Brief Title
Parathyroid Hormone for the Treatment of Humerus Fractures
Official Title
Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fractures
Keywords
proximal humeral fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Parathyroid hormone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
1-84 parathyroid hormone
Intervention Description
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline injection daily for 8 weeks.
Primary Outcome Measure Information:
Title
Changes in constant score
Description
Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.
Time Frame
5, 8, 11, 23, and 104 weeks.
Secondary Outcome Measure Information:
Title
Changes in Oxford Shoulder Score
Description
Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
Time Frame
5, 8, 11, 23, and 104 weeks.
Title
Changes in bone formation evaluated by X-ray.
Time Frame
5, 8, 11, 23, and 104 weeks.
Title
Changes in biochemical bone markers
Description
sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
Time Frame
0, 5, 25 weeks
Title
Changes in regulatory T lymphocytes
Description
Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
Time Frame
0, 8, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Hyldstrup, MDSc
Email
hyld@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich C Bang, M.D.
Email
ulrichbangbang@gmail.com
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Hyld, DMSc
Email
hyld@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Ulrich C Bang, M.D.
Email
ulrichbangbang@gmail.com
First Name & Middle Initial & Last Name & Degree
Ulrich C Bang, M.D.
First Name & Middle Initial & Last Name & Degree
Aage Vestergaard, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19594305
Citation
Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez 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.
Results Reference
background
PubMed Identifier
21915572
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.
Results Reference
background
Learn more about this trial
Parathyroid Hormone for the Treatment of Humerus Fractures
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