Study Summary
This trial is testing whether the drug abaloparatide can help heal fractures in postmenopausal women and men over 50. The study will last for 3 months, with participants taking either the drug or a placebo. The trial will be extended for 9 months to see if there are any differences between the groups.
Eligible Conditions
- Pelvic Fracture
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 12 months
12 months
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
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
Efficacy for fracture healing- Measured by participant cortical bridging scores
Efficacy measure of the time for participants to complete the Timed Up and Go Test.
8 weeks
Participant (percent) reporting narcotic use for pain
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
abaloparatide prefilled syringe
1 of 2
Placebo prefilled syringe
1 of 2
Active Control
Non-Treatment Group
78 Total Participants · 2 Treatment Groups
Primary Treatment: abaloparatide prefilled syringe · Has Placebo Group · Phase 2
Placebo prefilled syringe
Drug
PlaceboComparator Group · 1 Intervention: Placebo prefilled injector pen · Intervention Types: Drugabaloparatide prefilled syringe
Drug
ActiveComparator Group · 1 Intervention: Abaloparatide 80 micrograms per Pen dose · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
Weill Medical College of Cornell UniversityOTHER
990 Previous Clinical Trials
1,339,291 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
780 Previous Clinical Trials
483,052 Total Patients Enrolled
New York UniversityOTHER
205 Previous Clinical Trials
313,686 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
225 Previous Clinical Trials
60,676 Total Patients Enrolled
Westchester Medical CenterOTHER
6 Previous Clinical Trials
623 Total Patients Enrolled
Joseph Lane, MDPrincipal InvestigatorHospital for Special Surgery, New York
Jeri W Nieves, PhDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
35 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lanske, Beate, Heidi Chandler, Allen Pierce, Jeffery Brown, Michael Ominsky, Paul Kostenuik, and Gary Hattersley. 2019. “Abaloparatide, a PTH Receptor Agonist with Homology to Pthrp, Enhances Callus Bridging and Biomechanical Properties in Rats with Femoral Fracture”. Journal of Orthopaedic Research. Wiley. doi:10.1002/jor.24254.
- Benzinger, Petra, Clemens Becker, Ngaire Kerse, Florian Bleibler, Gisela Büchele, Andrea Icks, and Killian Rapp. 2013. “Pelvic Fracture Rates in Community-living People with and Without Disability and in Residents of Nursing Homes”. Journal of the American Medical Directors Association. Elsevier BV. doi:10.1016/j.jamda.2013.03.012.
- Peichl, Peter, Lukas A. Holzer, Richard Maier, and Gerold Holzer. 2011. “Parathyroid Hormone 1-84 Accelerates Fracture-healing in Pubic Bones of Elderly Osteoporotic Women”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.01379.
- Prieto-Alhambra, D., F. F. Avilés, A. Judge, T. Van Staa, X. Nogués, N. K. Arden, A. Díez-Pérez, C. Cooper, and M. K. Javaid. 2012. “Burden of Pelvis Fracture: A Population-based Study of Incidence, Hospitalisation and Mortality”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s00198-012-1907-z.
- Aspenberg, Per, Harry K Genant, Torsten Johansson, Antonio J Nino, Kyoungah See, Kelly Krohn, Pedro A García-Hernández, et al.. 2009. “Teriparatide for Acceleration of Fracture Repair in Humans: A Prospective, Randomized, Double-blind Study of 102 Postmenopausal Women with Distal Radial Fractures”. Journal of Bone and Mineral Research. Wiley. doi:10.1359/jbmr.090731.
- Alnaib, M., S. Waters, Y. Shanshal, N. Caplan, S. Jones, A. St Clair Gibson, and D. Kader. 2012. “Combined Pubic Rami and Sacral Osteoporotic Fractures: A Prospective Study”. Journal of Orthopaedics and Traumatology. Springer Science and Business Media LLC. doi:10.1007/s10195-012-0182-2.
- Bernhardsson, Magnus, and Per Aspenberg. 2018. “Abaloparatide Versus Teriparatide: A Head to Head Comparison of Effects on Fracture Healing in Mouse Models”. Acta Orthopaedica. Medical Journals Sweden AB. doi:10.1080/17453674.2018.1523771.
- Kannus, P., M. Palvanen, S. Niemi, J. Parkkari, and M. Järvinen. 2000. “Epidemiology of Osteoporotic Pelvic Fractures in Elderly People in Finland: Sharp Increase in 1970-1997 and Alarming Projections for the New Millennium”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s001980070112.
- Miller, Paul D., Gary Hattersley, Bente Juel Riis, Gregory C. Williams, Edith Lau, Luis Augusto Russo, Peter Alexandersen, et al.. 2016. “Effect of Abaloparatide Vs Placebo on New Vertebral Fractures in Postmenopausal Women with Osteoporosis”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.11136.
- Andrich, Silke, Burkhard Haastert, Elke Neuhaus, Kathrin Neidert, Werner Arend, Christian Ohmann, Jürgen Grebe, et al.. 2015. “Epidemiology of Pelvic Fractures in Germany: Considerably High Incidence Rates Among Older People”. Edited by Tuan Van Nguyen. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0139078.
- Demetriades, Demetrios, Marios Karaiskakis, George C. Velmahos, Kathleen Alo, James Murray, and Linda Chan. 2003. “Pelvic Fractures in Pediatric and Adult Trauma Patients”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ta.0000044352.00377.8f.
- Goldhahn, J., J.-M. Féron, J. Kanis, S. Papapoulos, J.-Y. Reginster, R. Rizzoli, W. Dere, B. Mitlak, Y. Tsouderos, and S. Boonen. 2012. “Implications for Fracture Healing of Current and New Osteoporosis Treatments: An ESCEO Consensus Paper”. Calcified Tissue International. Springer Science and Business Media LLC. doi:10.1007/s00223-012-9587-4.
- Krappinger, Dietmar, Christian Kammerlander, David J. Hak, and Michael Blauth. 2010. “Low-energy Osteoporotic Pelvic Fractures”. Archives of Orthopaedic and Trauma Surgery. Springer Science and Business Media LLC. doi:10.1007/s00402-010-1108-1.
- Ellegaard, M., N. R. Jørgensen, and P. Schwarz. 2010. “Parathyroid Hormone and Bone Healing”. Calcified Tissue International. Springer Science and Business Media LLC. doi:10.1007/s00223-010-9360-5.
- 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. Erratum In: JAMA. 2017 Jan 24;317(4):442.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jeri Nieves, PhD 2020. "Abaloparatide and Pelvic Fracture Healing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04249232.
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