NCT04249232|CompletedPhase 2DMCFDA Drug
Abaloparatide and Pelvic Fracture Healing
Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
Loading search results
Sponsor study identifier
interventional
48
1 country
3
Study Start
September 17, 2020
Actual (reported)Primary Completion
April 25, 2024
Actual (reported)Study Completion
April 25, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2020
Actual (reported)January 30, 2020
Actual (reported)September 17, 2020
Actual (reported)April 25, 2024
Actual (reported)April 25, 2024
Actual (reported)Efficacy for fracture healing- Measured by participant cortical bridging scores
Score for cortical bridging on a CT exam at 3 months in abaloparatide versus placebo groups.
3 months
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
8 weeks
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
12 months
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.
3 months
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.
12 months
Participant (percent) reporting narcotic use for pain
8 weeks
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.
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.
prefilled injector pen to deliver 80 micrograms daily subcutaneously
prefilled injector pen to deliver inactive solution daily subcutaneously
Hospital for Special Surgery
New York, New York, 10021, United States
Mount Sinai
New York, New York, 10029, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Prieto-Alhambra D, Aviles FF, Judge A, Van Staa T, Nogues X, Arden NK, Diez-Perez A, Cooper C, Javaid MK. Burden of pelvis fracture: a population-based study of incidence, hospitalisation and mortality. Osteoporos Int. 2012 Dec;23(12):2797-803. doi: 10.1007/s00198-012-1907-z. Epub 2012 Feb 4.
Kannus P, Palvanen M, Niemi S, Parkkari J, Jarvinen M. Epidemiology of osteoporotic pelvic fractures in elderly people in Finland: sharp increase in 1970-1997 and alarming projections for the new millennium. Osteoporos Int. 2000;11(5):443-8. doi: 10.1007/s001980070112.
Jeri W Nieves, PhD
Hospital for Special Surgery, New York
Joseph Lane, MD
Hospital for Special Surgery, New York
48 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2020
First Posted
January 30, 2020
Study Start
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, Grebe J, Vogt A, Jungbluth P, Rosler G, Windolf J, Icks A. Epidemiology of Pelvic Fractures in Germany: Considerably High Incidence Rates among Older People. PLoS One. 2015 Sep 29;10(9):e0139078. doi: 10.1371/journal.pone.0139078. eCollection 2015.
Benzinger P, Becker C, Kerse N, Bleibler F, Buchele G, Icks A, Rapp K. Pelvic fracture rates in community-living people with and without disability and in residents of nursing homes. J Am Med Dir Assoc. 2013 Sep;14(9):673-8. doi: 10.1016/j.jamda.2013.03.012. Epub 2013 May 13.
Melton LJ 3rd, Sampson JM, Morrey BF, Ilstrup DM. Epidemiologic features of pelvic fractures. Clin Orthop Relat Res. 1981 Mar-Apr;(155):43-7.
Alnaib M, Waters S, Shanshal Y, Caplan N, Jones S, St Clair Gibson A, Kader D. Combined pubic rami and sacral osteoporotic fractures: a prospective study. J Orthop Traumatol. 2012 Jun;13(2):97-103. doi: 10.1007/s10195-012-0182-2. Epub 2012 Mar 6.
Krappinger D, Kammerlander C, Hak DJ, Blauth M. Low-energy osteoporotic pelvic fractures. Arch Orthop Trauma Surg. 2010 Sep;130(9):1167-75. doi: 10.1007/s00402-010-1108-1. Epub 2010 Jun 3.
Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
Ellegaard M, Jorgensen NR, Schwarz P. Parathyroid hormone and bone healing. Calcif Tissue Int. 2010 Jul;87(1):1-13. doi: 10.1007/s00223-010-9360-5. Epub 2010 Apr 29.
Goldhahn J, Feron JM, Kanis J, Papapoulos S, Reginster JY, Rizzoli R, Dere W, Mitlak B, Tsouderos Y, Boonen S. Implications for fracture healing of current and new osteoporosis treatments: an ESCEO consensus paper. Calcif Tissue Int. 2012 May;90(5):343-53. doi: 10.1007/s00223-012-9587-4. Epub 2012 Mar 28.
Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136.
Bernhardsson M, Aspenberg P. Abaloparatide versus teriparatide: a head to head comparison of effects on fracture healing in mouse models. Acta Orthop. 2018 Dec;89(6):674-677. doi: 10.1080/17453674.2018.1523771. Epub 2018 Oct 18.
Lanske B, Chandler H, Pierce A, Brown J, Ominsky M, Kostenuik P, Hattersley G. Abaloparatide, a PTH receptor agonist with homology to PTHrP, enhances callus bridging and biomechanical properties in rats with femoral fracture. J Orthop Res. 2019 Apr;37(4):812-820. doi: 10.1002/jor.24254. Epub 2019 Mar 21.
Nieves JW, Cosman F, McMahon D, Berman H, Bartolotta RJ, Kazam JJ, Hentschel I, Egol K, Forsh D, Zhu YS, Yoo JE, Lane J. Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial. Osteoporos Int. 2026 Aug 20. doi: 10.1007/s00198-026-08176-2. Online ahead of print.
September 17, 2020
Primary Completion
April 25, 2024
Actual (reported)Study Completion
April 25, 2024
Actual (reported)Last Updated
June 14, 2024
Record last verified: 2024-06
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: