Sunday, June 15, 2025
6/15/2025
Planning for PTH(1-34) and Pelvic Fracture Healing - Randomized Controlled Trial - DESCRIPTION (provided by applicant): The incidence of pelvic fractures increases with age, with 92/100,000 per year in patients >60 years [1] and 446/100,000 per year in patients >85 years [2]. Pelvic fracture rates are higher in women [3] and 94% of pelvic fractures in patients >60 years of age are defined as osteoporosis-related fractures [1]. Pelvic fractures are the most common, relevant, and practical for this proposed randomized placebo controlled study. This fracture is accompanied by severe pain, chronic immobility and loss of function and independence in the elderly [4]. The current treatment strategy for pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. These fractures consume substantial healthcare resources, and from analysis of administrative claims data, they are one of the most costly osteoporosis related fractures [6]. 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. The goal of this U34 research is to prepare for a clinical trial where we plan to evaluate in patients >65 years of age with acute osteoporosis-related pelvic fractures, whether treatment with daily subcutaneous TPTD 20 mcg/day combined with standard care (pain management, bed rest and prevention of complications from comorbid conditions), compared with placebo injections and standard care is effective in enhancing fracture healing. During the one-year planning period, we will assess the willingness of this patient population to initiate therapy and feasibility of participation in the planned trial. The final protocol, Manual of Operations and safety plan, and IRB approvals will be completed. Fracture of the pubic ramus is most relevant and practical for this proposed 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 development of a successful adjunctive therapy available to accelerate fracture healing would lead to improved care and reduced costs for pelvic fractures. We 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 our future randomized, blinded trial in patient with acute pelvic fracture, we will address 3 specific aims over 3 months of treatment: 1. To determine if TPTD versus placebo (with standard care) results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a novel low radiation exposure CT technique. 2.To determine if TPTD versus placebo (with standard care) leads to a faster reduction in pain as assessed by both the Visual Analog Scale and a reduction in the use of narcotics. 3. To determine if TPTD versus placebo (with standard care) leads more rapidly to improved functional outcome using a short physical performance battery to assess lower extremity function.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).