Second study on the Effect of Teriparatide on Hip Fracture Healing

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1220

Inclusion Criteria

-Community dwelling men and postmenopausal women aged = 50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or non-displaced)
-Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years
-Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not a part of this protocol)
-Have given written informed consent (patient or proxy) after being informed of the risks, medications and study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 610
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 610

Exclusion Criteria

-Increased baseline risk of osteosarcoma; this includes patients with
Paget's diseaseof the bone, previous primary skeletal malignancy, or
skeletal exposure to therapeutic irradiation, including external beam
therapy or brachytherapy. As elevation of serum alkaline phosphatase
may indicate the presence of Paget's disease, an unexplained elevation
of this enzyme is also exclusionary.
-History of unresolved skeletal diseases affecting bone metabolism other
than primary osteoporosis including renal dystrophy, osteomalacia,
including glucocorticoid-induced osteoporosis, hyperparathyroidism
(uncorrected), and intestinal malabsorption
-Abnormally elevated values of serum calcium at baseline defined as =
10,6 mg/dL, except for clinically insignificant values as determined by
the investigator in conjunction with the Lilly clinical research physician
-Abnormally elevated values of serum intact parathyroid hormone (PTH)
(1-84) at baseline defined as >72 pg/mL
-Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin
D levels <9,2 ng/mL
-Active liver disease or jaundice
-Significantly impaired renal function at baseline based on serum
creatinine and/or measured or calculated creatininethat, in the opinion
of investigator, indicates significant renal impairment
-Abnormal thyroid function not corrected by therapy
-History of malignant neoplasm in the 5 years prior to Visit 1, with the
exception of superficial basal cell carcinoma or squamous cell carcinoma
of the skin that has been definitively treated. Patients with carcinoma in
situ of the uterine cervix treated definitively more than 1 year prior to
screening may enter the study.
-History of bone marrow or solid-organ transplantation
-History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior
to Visit 1
-Previous treatment with the following bone active drugs is allowed but
must be discontinued at Visit 1: oral bisphosphonates, selective estrogen
receptor modulators, calcitonin, estrogen (oral, transdermal or
injectable), progestin, estrogen analog, estrogen agonist, estrogen
antagonist or tibolone, and active Vit D analogues. Androgen or other
anabolic steroid use must be discontinued, except for use of physiologic
replacement testosterone.
-Previous treatment with the following bone active drugs is
exclusionary, if the stated treatment durations have been met: strontium
ranelate for any duration, intravenous bisphosphonates in the 12 months
preceding Visit 1, and/or denosumab in the 6 months preceding Visit 1
-Prior treatment with PTH, teriparatide, or other PTH analogs, or prior
participation in any other clinical trial studying PTH, teriparatide or other
PTH analogs
-Local or systemic treatment with bone morphogenic proteins or any
other growth factor
-Previous fracture(s) or bone surgery in the currently fractured hip
-Soft-tissue infection at the operation site
-Treatment with bone grafting or osteotomies
-Treatment with augmentation using any type of degradable cement,
hydroxyapatite-coated implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of
the foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis:
dislocations of the ankle, knee, or hips.