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

Glostrup University Hospital, Copenhagen

Status and phase: Withdrawn; Phase 2

Conditions: Shoulder Fractures; Trochanteric Fractures

Treatments: Drug: rhPTH(1-34)

Study type: Interventional

Funder types: Other

Identifiers

NCT00741182

EudraCT 2008-000094-37

FAO_06_011

Details and patient eligibility

About

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.

Sex: Female

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Femur PTH(1-34)

Experimental group

Description:

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

Treatment:

Drug: rhPTH(1-34)

Femur Control

No Intervention group

Description:

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

Humerus PTH(1-34)

Experimental group

Description:

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

Treatment:

Drug: rhPTH(1-34)

Humerus Control

No Intervention group

Description:

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