PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helen Hayes Hospital; Hospital for Special Surgery, New York
• Collaborators: Hospital for Special Surgery, New York; Weill Medical College of Cornell University
• Treatments: Teriparatide

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.