Parathyroid Hormone for the Treatment of Humerus Fractures
Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
1 active site
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
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 18, 2012
September 1, 2012
9 months
March 12, 2012
September 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (4)
Changes in Oxford Shoulder Score
5, 8, 11, 23, and 104 weeks.
Changes in bone formation evaluated by X-ray.
5, 8, 11, 23, and 104 weeks.
Changes in biochemical bone markers
0, 5, 25 weeks
Changes in regulatory T lymphocytes
0, 8, 24 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORParathyroid hormone
EXPERIMENTALInterventions
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
Eligibility Criteria
You may qualify if:
- proximal humeral fracture eligible for conservative treatment.
- able to understand the protocol
- signs an informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Takedacollaborator
Study Sites (1)
Hvidovre Hospital
Hvidovre, 2650, Denmark
Related Publications (2)
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.
PMID: 19594305BACKGROUNDPeichl 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.
PMID: 21915572BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 12, 2012
First Posted
September 18, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
September 18, 2012
Record last verified: 2012-09