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

Primary Purpose

Shoulder Fractures, Trochanteric Fractures

Status

Withdrawn

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

rhPTH(1-34)

About this trial

This is an interventional treatment trial for Shoulder Fractures focused on measuring Fracture, Osteoporosis, Forsteo, Teriparatide, Fracture healing

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Research Center for Ageing and Osteoporosis, Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Femur PTH(1-34)

Femur Control

Humerus PTH(1-34)

Humerus Control

Arm Description

24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment

24 participants with trochanteric fractures will be assigned to "no treatment"

24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment

24 participants with collum chirurgicum fracture will be assigned to "no treatment".

Outcomes

Primary Outcome Measures

Radiological evaluation of healing

Secondary Outcome Measures

Biochemical bone markers

SF-36 questionnaire

Full Information

NCT ID

NCT00741182

First Posted

August 25, 2008

Last Updated

March 17, 2015

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

The Danish Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00741182

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Withdrawn

Study Start Date

October 2008 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

The Danish Medical Research Council

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Fractures, Trochanteric Fractures

Keywords

Fracture, Osteoporosis, Forsteo, Teriparatide, Fracture healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Femur PTH(1-34)

Arm Type

Experimental

Arm Description

24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment

Arm Title

Femur Control

Arm Type

No Intervention

Arm Description

24 participants with trochanteric fractures will be assigned to "no treatment"

Arm Title

Humerus PTH(1-34)

Arm Type

Experimental

Arm Description

24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment

Arm Title

Humerus Control

Arm Type

No Intervention

Arm Description

24 participants with collum chirurgicum fracture will be assigned to "no treatment".

Intervention Type

Drug

Intervention Name(s)

rhPTH(1-34)

Other Intervention Name(s)

Forsteo, Forteo, Teriparatide

Intervention Description

Injection of 20 micrograms per day in eight weeks

Primary Outcome Measure Information:

Title

Radiological evaluation of healing

Time Frame

0, 4, 8, 12, (16) weeks after fracture

Secondary Outcome Measure Information:

Title

Biochemical bone markers

Time Frame

0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture

Title

SF-36 questionnaire

Time Frame

0, 4, 8, 12, (16) weeks after fracture

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Schwarz, MD, DMSci

Organizational Affiliation

Glostrup University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Center for Ageing and Osteoporosis, Glostrup University Hospital

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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