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

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ClinicalTrials.gov Identifier: NCT02972424
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Hospital for Special Surgery, New York
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Jeri Nieves, Ph.D., Helen Hayes Hospital

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).

Condition or disease Intervention/treatment Phase
Osteoporotic Fractures Drug: Teriparatide Prefilled Syringe Drug: Placebo Phase 2

Detailed Description:

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 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).

The investigators will extend this study with 9 months of open label TPTD to determine if any potential differences between the placebo and TPTD groups during the 3 months of treatment are evident and persist over time, even in patients who use TPTD after the three month placebo controlled intervention. If TPTD can improve fracture healing, this study will have an impact on the treatment of persons with pelvic fracture who are not surgical candidates and often face severe pain, chronic immobility, and loss of function in the elderly. A positive finding of accelerated healing of pelvic fractures would also encourage study of TPTD for treatment of other osteoporotic fractures.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Teriparatide Prefilled Syringe
TPTD is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.
Drug: Teriparatide Prefilled Syringe
TPTD 20 mcg
Other Name: Forteo

Placebo Comparator: Placebo
Placebo is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.
Drug: Placebo
Matching placebo as a prefilled syringe with all inactive ingredients
Other Name: Placebo prefilled syringe




Primary Outcome Measures :
  1. Evidence of cortical bridging for fracture healing [ Time Frame: 3 months ]
    Evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT,


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972424


Contacts
Contact: Kerry Canavan, R.N. 845-786-4802 canavank@helenhayeshosp.org

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Mariya Redko    212-606-1604    redkom@hss.edu   
Sponsors and Collaborators
Helen Hayes Hospital
Hospital for Special Surgery, New York
Weill Medical College of Cornell University
Investigators
Principal Investigator: Jeri W Nieves, PhD Helen Hayes Hospital

Responsible Party: Jeri Nieves, Ph.D., Associate Professor of Clinical Epidemiology, Helen Hayes Hospital
ClinicalTrials.gov Identifier: NCT02972424     History of Changes
Other Study ID Numbers: #15-04
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will make the data available for sharing 6-months after the publication of the primary paper. SAS datasets, a data dictionary, images of case report forms, SAS format library, the SAS program in which source data is recoded for analysis and data table summary descriptive statistics for data validation cross-check will be made available on an encrypted USB drive. A data sharing agreement is required.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeri Nieves, Ph.D., Helen Hayes Hospital:
pelvic fracture
healing
teriparatide

Additional relevant MeSH terms:
Fractures, Bone
Osteoporotic Fractures
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs