Effect of PTH(1-34) Treatment on Fracture Healing in Vivo | NCT00741182

Studies
Effect of PTH(1-34) Treatment on Fracture Healing in Vivo

NCT00741182

Sponsor

Glostrup University Hospital, Copenhagen

Status

Withdrawn

Last Update Posted

Mar 18, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Shoulder Fractures
Trochanteric Fractures

Interventions

rhPTH(1-34)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2008-000094-37

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Sep 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Name	Class
The Danish Medical Research Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Femur PTH(1-34)	Experimental	24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment	Drug: rhPTH(1-34)
Femur Control	No Intervention	24 participants with trochanteric fractures will be assigned to "no treatment"
Humerus PTH(1-34)	Experimental	24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment	Drug: rhPTH(1-34)
Humerus Control	No Intervention	24 participants with collum chirurgicum fracture will be assigned to "no treatment".

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhPTH(1-34)	Drug	Injection of 20 micrograms per day in eight weeks	Femur PTH(1-34) Humerus PTH(1-34)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological evaluation of healing		0, 4, 8, 12, (16) weeks after fracture

Secondary Outcomes

Measure	Description	Time Frame
Biochemical bone markers		0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
SF-36 questionnaire		0, 4, 8, 12, (16) weeks after fracture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute new osteoporotic trochanteric or collum chirurgicum fracture
Postmenopause

Exclusion Criteria:

Calcium metabolic disease other than osteoporosis
Diseases known to affect calcium homeostasis
Dementia
Hypersensitivity to drug or other components of medication
pre-existing hypercalcemia
Decreased kidney function
Increased alkaline phosphatase
Prior external radiation therapy or brachytherapy of the skeleton
Skeletal malignancies or bone metastases
Alcohol and/or drug abuse
Systemic treatment with corticosteroids within the last four weeks
Non-cooperating patients
Patients who do not speak and understand the danish language

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Schwarz, MD, DMSci	Glostrup University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Center for Ageing and Osteoporosis, Glostrup University Hospital		Copenhagen			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures
D006620	Hip Fractures
D050723	Fractures, Bone
D010024	Osteoporosis

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D005264	Femoral Fractures
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019379	Teriparatide

Ancestor Terms

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided