PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial
Condition: Osteoporotic Fractures
MeSH terms: Fractures, Bone; Osteoporotic Fractures; Hip Fractures
Intervention: Teriparatide Prefilled Syringe; Placebo
Intervention description: TPTD 20 mcg; Matching placebo as a prefilled syringe with all inactive ingredients
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: pelvic fracture; healing; teriparatide

Summary:

      In the proposed trial the investigators will recruit women and men >65 years of age with
      acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of
      treatment in a placebo controlled double blind study to determine if standard care and
      teriparatide 20 mcg/day versus placebo for pelvic fractures:

        1. Results in earlier evidence of cortical bridging on routine radiographs followed by
           confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans
           (primary outcome).

        2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a
           reduction in the use of narcotics (secondary outcome).

        3. Leads more rapidly to improved functional outcome using a short physical performance
           battery to assess lower extremity function (secondary outcome).
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal women and men >65 years of age with acute pelvic fractures, occurring with
        minimal trauma, presenting to Helen Hayes Hospital, Hospital for Special Surgery, or New
        York Hospital (Cornell Medical). Patients that have either one or multiple pelvic fractures
        or sacral and pelvic fractures will be included in the study. Subjects must start treatment
        within one month of hip fracture.

        Exclusion Criteria:

          1. Persons unable to complete the NRS and other surveys based on their mini-mental status
             score (≤18; consistent with moderate and severe cognitive impairment)

          2. Previously (prior to fracture) non-ambulatory subjects

          3. Exclusion criteria related to contraindication or intolerance to TPTD:

               1. Hypersensitivity to TPTD

               2. Patients with increased risk of osteosarcoma: Paget's disease, history of
                  radiation exposure

               3. Patients with active hypercalcemia

               4. Current hyperparathyroidism and other metabolic bone disease including
                  osteogenesis imperfecta

               5. History of multiple renal calculi or renal calculus within the last 2 years

               6. Normal alkaline phosphatase levels will not be used as an entrance criterion
                  because most fracture patients will have elevations due to the acute fracture.
                  However, the investigators will attempt to obtain lab tests from the period prior
                  to fracture to determine if they were normal. If unexplained elevations in
                  alkaline phosphatase are found in labs prior to the fracture we will exclude that
                  subject.

               7. Evidence of metastatic cancer or history of bone cancer or any active cancer
                  other than basal or squamous cell carcinoma.