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

Glostrup University Hospital, Copenhagen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Shoulder Fractures Trochanteric Fractures

Interventions

rhPTH(1-34)DRUG

Injection of 20 micrograms per day in eight weeks

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Center for Ageing and Osteoporosis, Glostrup University Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Radiological evaluation of healing

Time frame: 0, 4, 8, 12, (16) weeks after fracture

Secondary Outcomes

Biochemical bone markers

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

SF-36 questionnaire

Time frame: 0, 4, 8, 12, (16) weeks after fracture

Data from ClinicalTrials.gov

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