Teriparatide for Fracture Repair in Humans

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• recent proximal 2-segment humerus fracture (0-8 days post fracture)

• no surgical treatment at fractured site

• signed informed consent

• postmenopausal female and male patients aged 60 - 85 years

• established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip

Exclusion Criteria:

• Hypersensitivity to the active substance or to any of the excipients.

• Pre-existing hypercalcemia

• Severe renal impairment (eGFR< 35ml/min)

• Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.

• Unexplained elevations of alkaline phosphatase

• Prior external beam or implant radiation therapy to the skeleton

• Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.

• any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)

• any prior strontium ranelate therapy

• any prior TPTD of PTH 1-84 therapy

• malignancies ≤ 5 years except basalioma

• hypo-/hypercalcemia

• baseline 25-OH vitamin D3 level ≤10 ng/ml

• prosthesis at fractured and contralateral humerus