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

NCT ID: NCT00741182

Last Updated: 2015-03-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Fractures Trochanteric Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Femur PTH(1-34)

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

Group Type EXPERIMENTAL

rhPTH(1-34)

Intervention Type DRUG

Injection of 20 micrograms per day in eight weeks

Femur Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Humerus PTH(1-34)

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

Group Type EXPERIMENTAL

rhPTH(1-34)

Intervention Type DRUG

Injection of 20 micrograms per day in eight weeks

Humerus Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rhPTH(1-34)

Injection of 20 micrograms per day in eight weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Forsteo Forteo Teriparatide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Danish Medical Research Council

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Glostrup University Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Schwarz, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Center for Ageing and Osteoporosis, Glostrup University Hospital

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT 2008-000094-37

Identifier Type: -

Identifier Source: secondary_id

FAO_06_011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

7 Day Continuous Parathyroid Hormone IV Infusion
NCT00377312 COMPLETED EARLY_PHASE1
Open Label Extension Study of PREOS
NCT00172133 COMPLETED PHASE3