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

Sponsors and Collaborators:	Glostrup University Hospital,Copenhagen The Danish Medical Research Council
Information provided by:	Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:	NCT00741182

Purpose

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.

Condition	Intervention	Phase
Shoulder Fractures Trochanteric Fractures	Drug: rhPTH(1-34)	Phase II

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Osteoporosis Shoulder Injuries and Disorders

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effect of PTH(1-34) Treatment on Fracture Healing in Vivo

Further study details as provided by Glostrup University Hospital,Copenhagen:

Primary Outcome Measures:

Radiological evaluation of healing [ Time Frame: 0, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biochemical bone markers [ Time Frame: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]
SF-36 questionnaire [ Time Frame: 0, 4, 8, 12, (16) weeks after fracture ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Femur PTH(1-34): Experimental 24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment	Drug: rhPTH(1-34) Injection of 20 micrograms per day in eight weeks
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) Injection of 20 micrograms per day in eight weeks
Humerus Control: No Intervention 24 participants with collum chirurgicum fracture will be assigned to "no treatment".

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741182

Locations

Denmark
Research Center for Ageing and Osteoporosis, Glostrup University Hospital	Recruiting
Copenhagen, Denmark
Contact: Maria Ellegaard, M.sc. +45 43234695 marlar04@glo.regionh.dk
Principal Investigator: Peter Schwarz, MD, DMSci
Sub-Investigator: Tommy K Larsen, MD
Sub-Investigator: Maria Ellegaard, M.sc.
Sub-Investigator: Niklas R Jørgensen, MD,PhD,DMSci

Sponsors and Collaborators

Glostrup University Hospital,Copenhagen

The Danish Medical Research Council

Investigators

Principal Investigator:

Peter Schwarz, MD, DMSci

Glostrup University Hospital

More Information

Responsible Party:	Glostrup University Hospital ( Peter Schwarz, Professor, MD, DMSci )
Study ID Numbers:	FAO_06_011, EudraCT 2008-000094-37
Study First Received:	August 25, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00741182
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency

Keywords provided by Glostrup University Hospital,Copenhagen:

Fracture
Osteoporosis
Forsteo
Teriparatide
Fracture healing

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Teriparatide
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Osteoporosis
Leg Injuries
Arm Injuries
Shoulder Fractures

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Hip Injuries
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009