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Abaloparatide and Pelvic Fracture Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249232
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : January 5, 2023
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
New York University
Westchester Medical Center
Information provided by (Responsible Party):
Jeri Nieves, PhD, Hospital for Special Surgery, New York

Study Description
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Brief Summary:
This is a prospective randomized, double-blinded, placebo-controlled, phase 2, three-month study of the efficacy of abaloparatide in postmenopausal women and men ≥ 50 years of age with acute fractures of the pelvis (n=78). The primary outcome is CT image based evidence of fracture healing. The secondary aims are pain and physical performance measures at 3 months. This study will be extended with 9 months of open label abaloparatide to determine if any potential differences between the placebo and abaloparatide groups during the 3 months of treatment are evident and persist over time, even in patients who use abaloparatide after the three-month placebo controlled intervention.

Condition or disease Intervention/treatment Phase
Fracture of Pelvis (Disorder) Drug: Abaloparatide 80 micrograms per Pen dose Drug: Placebo prefilled injector pen Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment with randomization
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple
Primary Purpose: Treatment
Official Title: Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: abaloparatide prefilled syringe
Abaloparatide-SC is supplied as a liquid, 3120 micrograms per 1.56 milliliter (2000 mcg/mL) in a single patient multi-use prefilled pen. The prefilled pen delivers 30 doses of abaloparatide, each containing 80 mcg of abaloparatide in 40 microliters of a sterile, clear, colorless solution. To be administered subcutaneously daily.
 Drug: Abaloparatide 80 micrograms per Pen dose
prefilled injector pen to deliver 80 micrograms daily subcutaneously
Other Name: Tymlos
Placebo Comparator: Placebo prefilled syringe
For the placebo-SC a prefilled multi-use pen injector cartridge is designed to deliver 30 doses of placebo each in 40 microliters of sterile, clear, colorless solution to be administered subcutaneously daily.
 Drug: Placebo prefilled injector pen
prefilled injector pen to deliver inactive solution daily subcutaneously
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy for fracture healing- Measured by participant cortical bridging scores [ Time Frame: 3 months ]
    Score for cortical bridging on a CT exam at 3 months in abaloparatide versus placebo groups.


Secondary Outcome Measures :
  1. Efficacy measure of participant pain score as assessed by the Numeric Rating Scale [ Time Frame: 8 weeks ]
    Pain score measured by Numeric rating scale that uses a scale from 0 (no pain) to 10 (worst pain imaginable), the subject will report how intense their pain is now and how intense it was on average last week. This will be compared in the abaloparatide versus placebo groups.

  2. Efficacy measure of participant pain score as assessed by the Numeric Rating Scale [ Time Frame: 12 months ]
    Pain score measured by Numeric rating scale that uses a scale from 0 (no pain) to 10 (worst pain imaginable), the subject will report how intense their pain is now and how intense it was on average last week. This will be compared over time in the abaloparatide versus placebo groups.

  3. Participant lower extremity function based on a score from the Continuous Summary Physical Performance Score. The measure of lower extremity physical function is an efficacy variable. [ Time Frame: 3 months ]
    Physical function as an efficacy outcome using a continuous summary physical performance score based on a battery of tests, including walk speed, repeated chair stands and balance.

  4. Participant lower extremity function based on a score from the Continuous Summary Physical Performance Score. The measure of lower extremity physical function is an efficacy variable. [ Time Frame: 12 months ]
    Physical function as an efficacy outcome using a continuous summary physical performance score based on a battery of tests, including walk speed, repeated chair stands and balance.

  5. Participant (percent) reporting narcotic use for pain [ Time Frame: 8 weeks ]
    The use of narcotics will be collected at each visit and will be quantified into morphine equivalents. ABALOPARATIDE versus placebo groups will be compared for morphine equivalents.

  6. Efficacy measure of the time for participants to complete the Timed Up and Go Test. [ Time Frame: 3 months ]

    The test begins by having the subject Stand up from the chair, walk to the line on the floor at a normal pace, turn, walk back to the chair at a normal pace and sit down again. The person administering the test will time the subject using a stopwatch.

    including walk speed, repeated chair stands and balance. In addition,Timed up and go score.



Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women and men >50 years of age with acute pelvic fractures, occurring with minimal trauma, presenting to Mount Sinai, New York University, New York Presbyterian-Queens, Hospital for Special Surgery, or New York Hospital (Cornell Medical) within one month of the onset of symptoms.

Exclusion Criteria:

  1. Persons unable to complete the NRS and other surveys based on assessment by the study doctor.
  2. Previously (prior to fracture) non-ambulatory subjects

  3. Exclusion criteria related to contraindication or intolerance to ABALOPARATIDE:

    1. Hypersensitivity to ABALOPARATIDE
    2. Patients with increased risk of osteosarcoma: Paget's disease, history of radiation treatment
    3. Patients with active hypercalcemia based on serum calcium above the upper limit of normal.
    4. Serum creatinine cannot be elevated more than 1.5 times above upper normal limit for age
    5. Current diagnosis of hyperparathyroidism and other metabolic bone disease including osteogenesis imperfecta
    6. Multiple Kidney stones (calcium oxalate) within the last 10 years or single kidney stone (calcium oxalate) within the last year. If stone type is not known, a 24-hour urine calcium determination can be performed; if not elevated, the patient does not require exclusion.
    7. 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, we will attempt to obtain lab tests from the period prior to fracture to determine if they were normal. If unexplained elevations in alkaline phosphatase (more than 1.5 times above the upper limit of normal) are found in labs prior to the fracture, we will exclude that subject.
    8. Diagnosis of metastatic cancer within the past 10 years; primary bone cancer or multiple myeloma at any time. For other primary active non-skin cancers (diagnosed within the last 5 years), the patient's oncologist should be consulted to determine participant eligibility.
Contacts and Locations
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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): NCT04249232


Contacts
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Contact: Heather Berman 212-606-1604 bermanh@hss.edu
Contact: Jeri Nieves, PhD 212-606-1604 Nievesje@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Heather Berman    212-606-1604    bermanh@hss.edu   
Contact: Joseph Lane, MD    212-606-1604    lanej@hss.edu   
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Richawna Cassie    212-241-6605    richawna.cassie@mountsinai.org   
Contact: David Forsh, MD    212-241-1228    carolina.stocchi@mountsinai.org   
Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
Contact: Blossom Samuels, MD    914-493-6051    blossom.samuels@wmchealth.org   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
New York University
Westchester Medical Center
Investigators
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Principal Investigator: Jeri W Nieves, PhD Hospital for Special Surgery, New York
Principal Investigator: Joseph Lane, MD Hospital for Special Surgery, New York
More Information
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Publications:

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Responsible Party: Jeri Nieves, PhD, Professor of Clinical Epidemiology and Senior Research Scientist, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04249232    
Other Study ID Numbers: 2019-1978
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data is identified by an anonymous study identification. No protected health information is stored in the research database. The possibility of individual subject identification is nil from within the purview of the data. The data will be made available for sharing 12-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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: within one year of study completion
Access Criteria: A data sharing agreement is required. Dr. Nieves and Dr. Lane will give priority to data sharing requests with the stated purpose of a) Teaching, b) replication or reanalysis of results reported in the primary paper, c) subgroup analyses to be used for the design of future research. Other requests will be considered on a caseby- case basis. Hospital for Special Surgery legal office for research will provide details on their policy.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeri Nieves, PhD, Hospital for Special Surgery, New York:
abaloparatide
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
 Leg Injuries
Abaloparatide
Bone Density Conservation Agents
Physiological Effects of Drugs