Teriparatide for fracture repair of proximal humerus fracture

Conditions: Osteoporotic humerus fracture - accelerated fracture repair
MedDRA version: 17.0Level: LLTClassification code 10031288Term: Osteoporosis with fractureSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-002154-39-AT

Lead Sponsor: Vinforce - Institut für Osteoporoseforschung

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•recent proximal 2-segment humerus fracture (0-8 days post fracture)
•no surgical treatment at fractured site
•informed consent
•postmenopausal female and male patients aged 60 – 85 years
•established osteoporosis as defined by BMD measured with DXA-technology with a T-score = -2.0 spine or hip

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

•any contraindication against teriparatide (TPTD, rhPTH 1-34)
oHypersensitivity to the active substance or to any of the excipients.
oPre-existing hypercalcemia
oSevere renal impairment (eGFR< 35ml/min)
oMetabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
oUnexplained elevations of alkaline phosphatase
oPrior external beam or implant radiation therapy to the skeleton
oPatients 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