Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Hum... | NCT02090244

Studies
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?

NCT02090244

Sponsor

University Hospital, Linkoeping

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

34Actual

Phase

Phase 4

Conditions

Spinal Stenosis

Interventions

Teriparatide

Countries

Sweden

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
2011-002917-12	EudraCT Number

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012Actual

Primary Completion Date

May 2018Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Mar 16, 2014

First Submission Date that Met QC Criteria

Mar 16, 2014

First Posted Date

Mar 18, 2014Estimated

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

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Name	Class
Medical Research Council of Southeast Sweden	OTHER_GOV

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

Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.

Detailed Description

100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control.

Primary outcome: The rate of healing at 6 months on CT Scans. Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Standard care postoperatively.
Teriparatide	Experimental	One injection daily for 4 weeks	Drug: Teriparatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teriparatide	Drug	Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks	Teriparatide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of bone healing after spinal stenosis surgery	A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.	6 months + more than 2 years postoperatively.

Secondary Outcomes

Measure	Description	Time Frame
Pain	Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.	At 3 and 6 months.
Function	Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

Exclusion Criteria:

•dementia or psychiatric disorder
- known malignancy < 5 years prior to fracture
- calcium above reference value
- signs of liver disease
- creatinine over ref. value
- inflammatory joint disease
- alcohol or drug abuse
- oral corticosteroid medication
- long-term NSAID-treatment (=> 3 months prior to fracture)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Ottesen, MD	Ryggkliniken, US Linköping	Principal Investigator
Patrik Bernestrå, MD	Ortopedkliniken, Kalmar, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ortopedkliniken		Kalmar			Sweden
Ryggkliniken, US Linköping

Condition Browse Module

MeSH Terms

ID	Term
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

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