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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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).

Detailed Summary:

The incidence rate of pelvic fractures increases dramatically with age, from 5.4 and 3.8 per 10,000 person-years in women and men aged 65 to 69 years to 93.5 and 44.5 per 10,000 person-years in women and men aged 90 years and older, respectively. Pelvic fractures are accompanied by severe pain, chronic immobility and loss of function and independence in the elderly. Pelvic fractures consume substantial healthcare resources, and based on administrative claims data, they are one of the most costly osteoporosis related fractures. Un-healed fractures, occurring in one-third of pelvic fracture patients at 3 months, can cause continued pain and impact mobility. With aging of the population, and expected concomitant increase in the incidence of pelvic fractures, there is a pressing need to find effective treatments that will accelerate healing. Fracture of the pubic ramus is most relevant and practical for randomized double-blinded placebo controlled study as this fracture is accompanied by severe pain and immobility in elderly, is associated with delayed fracture healing, and is almost always treated non-operatively. The current standard of care for pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. The investigators hypothesize that development of a successful adjunctive therapy to accelerate fracture healing would lead to improved care and reduce both direct and indirect costs from pelvic fractures. 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 cortic
   Sponsor: Helen Hayes Hospital
   

   Current Primary Outcome: Evidence of cortical bridging for fracture healing [ Time Frame: 3 months ]

   Evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT,
   
   
   

   Original Primary Outcome: Same as current
   
   

   Current Secondary Outcome:

   • Faster reduction in pain by numeric rating scale [ Time Frame: 3 months ]
     Leads to a faster reduction in pain as assessed by the Numeric Rating Scale
   • Faster reduction in pain by reduced use of narcotics [ Time Frame: 3 months ]
     Leads to a faster reduction in pain as assessed by a reduction in the use of narcotics
   • more rapidly improved functional outcome using a battery that includes walking speed, repeated chair stands, and balance [ Time Frame: 3 months ]
     More rapidly improved functional outcome using a short physical performance battery to assess lower extremity function (walking speed, repeated chair stands, and balance) at 3 months.
   • Physical Function at 12 months using a battery that includes walking speed, repeated chair stands, and balance [ Time Frame: 12 months ]
     More rapidly improved functional outcome using a short physical performance battery to assess lower extremity function (walking speed, repeated chair stands, and balance) at 12 months.
   • Pain at 12 months based on the numeric rating scale [ Time Frame: 12 months ]
     Pain at 12 months as assessed by both the Numeric Rating Scale
   
   
   

   Original Secondary Outcome: Same as current
   
   Information By: Helen Hayes Hospital
   

   Dates:
   Date Received: November 18, 2016
   Date Started: January 2017
   Date Completion: November 2021
   Last Updated: November 21, 2016
   Last Verified: November 2016