Parathyroid Hormone for the Treatment of Humerus Fractures

NCT ID: NCT01687374

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Fractures

Keywords

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proximal humeral fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline injection daily for 8 weeks.

Parathyroid hormone

Group Type EXPERIMENTAL

1-84 parathyroid hormone

Intervention Type DRUG

100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.

Interventions

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1-84 parathyroid hormone

100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.

Intervention Type DRUG

Placebo

Saline injection daily for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Bang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lars Hyldstrup, MDSc

Role: CONTACT

Email: [email protected]

Ulrich C Bang, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Lars Hyld, DMSc

Role: primary

Ulrich C Bang, M.D.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19594305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21915572 (View on PubMed)

Other Identifiers

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HvH-2011-545-1

Identifier Type: -

Identifier Source: org_study_id