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Trial · Interventional

CompletedPhase 2Registry data

Abaloparatide and Pelvic Fracture Healing

NCTNCT04249232 (opens ClinicalTrials.gov in a new tab)Other id2019-1978
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
48 participants (actual)
Sponsor
Hospital for Special Surgery, New York · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
17 Sept 2020
Primary completion
25 Apr 2024
Completion
25 Apr 2024
First posted
30 Jan 2020
Last update posted
14 Jun 2024
Conditions
Fracture of Pelvis (Disorder)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. Ph 2

    Abaloparatide and Pelvic Fracture Healing

    NCT04249232

    17 Sept 2020 to 25 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Abaloparatide 80 micrograms per Pen doseDrug
  • Placebo prefilled injector penDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy for fracture healing- Measured by participant cortical bridging scores

    Time frame · 3 months

    Registry description

    Score for cortical bridging on a CT exam at 3 months in abaloparatide versus placebo groups.

Secondary outcomes(6)

  1. Efficacy measure of participant pain score as assessed by the Numeric Rating Scale

    Time frame · 8 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2026

7 results

Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial.

Nieves et al. 2026Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

PMID 42618812DOI 10.1007/s00198-026-08176-2PUB-42618812

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Animal study · 2019

10 results

Abaloparatide, a PTH receptor agonist with homology to PTHrP, enhances callus bridging and biomechanical properties in rats with femoral fracture.

Lanske et al. 2019Journal of orthopaedic research : official publication of the Orthopaedic Research Societycited by 21

PMID 30790359DOI 10.1002/jor.24254PUB-30790359

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Observational study · 2018

8 results

Abaloparatide versus teriparatide: a head to head comparison of effects on fracture healing in mouse models.

Bernhardsson et al. 2018Acta orthopaedicacited by 31

PMID 30334479PMC6300720DOI 10.1080/17453674.2018.1523771PUB-30334479

CC BY8 results
Download PDFSee results (8)

Indexing hint: Randomized controlled trial · 2010

3 results

Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.

Aspenberg et al. 2010Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 368

PMID 19594305DOI 10.1359/jbmr.090731PUB-19594305

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2016

Corrected

Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial.

Miller et al. 2016JAMAcited by 632

PMID 27533157DOI 10.1001/jama.2016.11136PUB-27533157

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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