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

NCT00741182 | Withdrawn Phase 2 DMC

• 2 other identifiers: FAO_06_011EudraCT 2008-000094-37
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Fractures; Trochanteric Fractures

Keywords

Fracture; Osteoporosis; Forsteo; Teriparatide; Fracture healing

Outcome Measures

Primary Outcomes (1)

• Radiological evaluation of healing

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

Secondary Outcomes (2)

• 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

Study Arms (4)

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

rhPTH(1-34) DRUG

Injection of 20 micrograms per day in eight weeks

Also known as: Forsteo, Forteo, Teriparatide

Femur PTH(1-34); Humerus PTH(1-34)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute new osteoporotic trochanteric or collum chirurgicum fracture
• Postmenopause

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• The Danish Medical Research Council: collaborator

Study Sites (1)

Research Center for Ageing and Osteoporosis, Glostrup University Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Shoulder Fractures; Hip Fractures; Fractures, Bone; Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Schwarz, MD, DMSci

  Glostrup University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2009-08

Locations

DK (1)