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

Condition(s) targeted: Shoulder Fractures; Trochanteric Fractures

Intervention: rhPTH(1-34) (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Glostrup University Hospital, Copenhagen

Official(s) and/or principal investigator(s):
Peter Schwarz, MD, DMSci, Principal Investigator, Affiliation: Glostrup University Hospital

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Radiological evaluation of healing

Secondary outcome:

Biochemical bone markers

SF-36 questionnaire

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Female.

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

Research Center for Ageing and Osteoporosis, Glostrup University Hospital, Copenhagen, Denmark

Starting date: October 2008
Last updated: March 17, 2015