Second Study of the Effect of Teriparatide on Hip Fracture Healing
Condition: Femur Neck Fracture
MeSH terms: Fractures, Bone; Femoral Neck Fractures
Intervention: Teriparatide; Placebo; Calcium supplementation; Vitamin D supplementation
Intervention description: Administered by SC injection; Administered by SC injection; Administered orally; Administered orally
Intervention MeSH terms: Vitamin D; Teriparatide; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,
      will improve the healing of hip (femoral neck) fractures that are repaired during surgery
      using certain types of orthopedic screws. The study will enroll men and postmenopausal women
      at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for
      example, fall from standing height or less).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community dwelling men and postmenopausal women who were ambulatory before sustaining
             a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)

          -  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 performed as part of this study)

          -  Have given written informed consent (participant or proxy) after being informed of the
             risks, medications, and study procedures

        Exclusion Criteria:

          -  Increased baseline risk of osteosarcoma

          -  History of unresolved skeletal diseases affecting bone metabolism other than primary
             osteoporosis

          -  Abnormally elevated serum calcium at screening

          -  Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening

          -  Severe vitamin D deficiency at screening

          -  Active liver disease or jaundice

          -  Significantly impaired renal function

          -  Abnormal thyroid function not corrected by therapy

          -  History of malignant neoplasm in the 5 years prior to screening

          -  History of bone marrow or solid organ transplantation

          -  History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
             screening

          -  Previous treatment with the following bone active drugs is allowed but must be
             discontinued at screening: oral bisphosphonates, selective estrogen receptor
             modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
             progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
             active vitamin D3 analogs. 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 screening, and/or denosumab in the 6 months
             preceding screening

          -  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 hip