Fracture of Pelvis (Disorder)Phase 2NCT04249232
Abaloparatide and Pelvic Fracture Healing
A Phase 2 study testing Abaloparatide 80 micrograms per Pen dose in people with Fracture of Pelvis (Disorder), run by Hospital for Special Surgery, New York at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fracture of Pelvis (Disorder)
- What is being tested?
- Abaloparatide 80 micrograms per Pen dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Sep 2020to 25 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Persons unable to complete the NRS and other surveys based on assessment by the study doctor.
- Previously (prior to fracture) non-ambulatory subjects
- Exclusion criteria related to contraindication or intolerance to ABALOPARATIDE:
- Hypersensitivity to ABALOPARATIDE
- Patients with increased risk of osteosarcoma: Paget's disease, history of radiation treatment
- Patients with active hypercalcemia based on serum calcium above the upper limit of normal.
Show all 11Show fewer
- Serum creatinine cannot be elevated more than 1.5 times above upper normal limit for age
- Current diagnosis of hyperparathyroidism and other metabolic bone disease including osteogenesis imperfecta
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital for Special Surgery
New York, New York, 10021
Mount Sinai
New York, New York, 10029
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
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.
Read the detailed description
By 2030 over 25% of the entire US population will be older than 65 years of age. Pelvic fracture rates are higher in women. Over 90% of pelvic fractures in patients >60 years are defined as osteoporosis related fractures. In a recent study in Germany, the rate of all first pelvic fractures in persons over 60 was 22.4 [95% CI 22.0-22.9] per 10,000 person-years. The incidence rate 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. This is in agreement with studies in the US and Finland, also showing an increase in incidence of pelvic fractures with age. Pelvic fractures are most often a result of low-energy trauma, such as a fall from standing height. Pelvic fractures are the most relevant for this proposed randomized placebo-controlled study. This fracture is accompanied by severe pain, chronic immobility and loss of function and independence in the elderly. The current treatment strategy of pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. In a review of six studies with over 500 patients, the mean length of hospital stay was 13.4 days and the average 1-year mortality was 16.3%. Mortality rates in 1300 pelvic fracture patients were still elevated at 3 years. Pelvic fractures are associated with slow healing and a delayed return to full function and normal activity. 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. There are strong preclinical data, as well as clinical evidence, that administration of parathyroid hormone (PTH) receptor agonists may improve bone union, hasten fracture healing and improve physical function. In one nonrandomized, un-blinded study, 100% of pelvic fracture patients given 1-84PTH were healed within 12 weeks compared to 68% of the controls. However, there is not sufficient evidence at this time to recommend routine use of PTH receptor agonists for fracture healing. Pelvic fractures are ideal to study for the impact of abaloparatide on rate of fracture healing because there are no surgical repairs for the vast majority of the fractures. Prior studies of teriparatide on wrist fracture healing were limited and confounded by the increased prevalence of surgical fixation to treat these fractures. Strong evidence of pelvic fracture healing that may result from this study may not only have an impact on pelvic fractures but perhaps may indicate a potential use for other fractures as well.
In the proposed randomized, double blind, placebo controlled clinical trial in patients >50 years of age with acute pelvic fracture, the investigators plan to evaluate whether treatment with daily subcutaneous ABALOPARATIDE 80 mcg/day compared with placebo, in addition to standard treatment (pain management, bed rest and prevention of complications from comorbid conditions), is effective in accelerating fracture healing in women and men compared to standard treatment alone. The investigators hypothesize that development of a successful adjunctive therapy (ABALOPARATIDE) will accelerate radiographic evidence of fracture healing and speed functional recovery. If this hypothesis holds true, it would lead to a change in clinical practice and an improved quality of care for pelvic fracture patients. Evidence of an impact on the healing of pelvic fractures may also extend to a potential to improve healing of other osteoporosis-related fractures. In the planned trial the investigators will recruit women and men with acute pelvic fractures and address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if ABALOPARATIDE in addition to standard care versus placebo and standard care:
- Results in evidence of more complete cortical bridging at 3 months using focus CT to reduce radiation exposure from CT scans (primary outcome).
- 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).
- Leads more to a more rapidly improved functional outcome using measures to assess lower extremity function (Continuous Summary Physical Performance Score and Timed Up and Go- secondary outcomes).
Although the primary analysis will be based on data from 0 to 3 months, whether the benefit of ABALOPARATIDE on fracture healing wanes over time is unclear, making a longer follow-up important to extend knowledge on the persistence of early ABALOPARATIDE effect on these outcomes. Therefore, the investigators will extend this study 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.
If ABALOPARATIDE 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 ABALOPARATIDE for treatment of other osteoporotic fractures.
- Conditions
- Fracture of Pelvis (Disorder)
- Being tested
- Abaloparatide 80 micrograms per Pen dose, Placebo prefilled injector pen
- Keywords
- abaloparatide
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abaloparatide 80 micrograms per Pen doseDrug
Also called Tymlos
prefilled injector pen to deliver 80 micrograms daily subcutaneously
Placebo prefilled injector penDrug
Also called placebo
prefilled injector pen to deliver inactive solution daily subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| abaloparatide prefilled syringe | Active comparator | 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. Receives: Drug: Abaloparatide 80 micrograms per Pen dose |
| Placebo prefilled syringe | Placebo comparator | 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. Receives: Drug: Placebo prefilled injector pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
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.
Measured: 8 weeks
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 12 months
Participant (percent) reporting narcotic use for pain
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.
Measured: 8 weeks
Efficacy measure of the time for participants to complete the Timed Up and Go Test.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start17 Sep 2020
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fracture of Pelvis (Disorder)Studies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, New York University, Westchester Medical Center
- Responsible party
- Principal investigator, Jeri Nieves, PhD, Hospital for Special Surgery, New York
- Investigators
- Jeri W Nieves, PhD, Principal investigator, Hospital for Special Surgery, New YorkJoseph Lane, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249232
- Sponsor's protocol ID
- 2019-1978
- Status last verified
- Jun 2024
- First submitted
- 27 Jan 2020
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22310957Kannus 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.
PubMed 10912847Andrich 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.
PubMed 26418971Benzinger 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.
PubMed 23680402Melton LJ 3rd, Sampson JM, Morrey BF, Ilstrup DM. Epidemiologic features of pelvic fractures. Clin Orthop Relat Res. 1981 Mar-Apr;(155):43-7.
PubMed 7226629Alnaib 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.
PubMed 22391943Krappinger 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.
PubMed 20521061Peichl 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.
PubMed 21915572Ellegaard 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.
PubMed 20428858Goldhahn 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.
PubMed 22451221Aspenberg 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.
PubMed 19594305Miller 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.
PubMed 27533157Bernhardsson 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.
PubMed 30334479Lanske 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.
PubMed 30790359Nieves 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.
PubMed 42618812
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04249232
- Acronym / sponsor ID
- 2019-1978
- Conditions
- Fracture of Pelvis (Disorder)
- Keywords
- abaloparatide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, New York University, Westchester Medical Center
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By 2030 over 25% of the entire US population will be older than 65 years of age. Pelvic fracture rates are higher in women. Over 90% of pelvic fractures in patients >60 years are defined as osteoporosis related fractures. In a recent study in Germany, the rate of all first pelvic fractures in persons over 60 was 22.4 [95% CI 22.0-22.9] per 10,000 person-years. The incidence rate 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. This is in agreement with studies in the US and Finland, also showing an increase in incidence of pelvic fractures with age. Pelvic fractures are most often a result of low-energy trauma, such as a fall from standing height. Pelvic fractures are the most relevant for this proposed randomized placebo-controlled study. This fracture is accompanied by severe pain, chronic immobility and loss of function and independence in the elderly. The current treatment strategy of pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. In a review of six studies with over 500 patients, the mean length of hospital stay was 13.4 days and the average 1-year mortality was 16.3%. Mortality rates in 1300 pelvic fracture patients were still elevated at 3 years. Pelvic fractures are associated with slow healing and a delayed return to full function and normal activity. 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. There are strong preclinical data, as well as clinical evidence, that administration of parathyroid hormone (PTH) receptor agonists may improve bone union, hasten fracture healing and improve physical function. In one nonrandomized, un-blinded study, 100% of pelvic fracture patients given 1-84PTH were healed within 12 weeks compared to 68% of the controls. However, there is not sufficient evidence at this time to recommend routine use of PTH receptor agonists for fracture healing. Pelvic fractures are ideal to study for the impact of abaloparatide on rate of fracture healing because there are no surgical repairs for the vast majority of the fractures. Prior studies of teriparatide on wrist fracture healing were limited and confounded by the increased prevalence of surgical fixation to treat these fractures. Strong evidence of pelvic fracture healing that may result from this study may not only have an impact on pelvic fractures but perhaps may indicate a potential use for other fractures as well.
In the proposed randomized, double blind, placebo controlled clinical trial in patients >50 years of age with acute pelvic fracture, the investigators plan to evaluate whether treatment with daily subcutaneous ABALOPARATIDE 80 mcg/day compared with placebo, in addition to standard treatment (pain management, bed rest and prevention of complications from comorbid conditions), is effective in accelerating fracture healing in women and men compared to standard treatment alone. The investigators hypothesize that development of a successful adjunctive therapy (ABALOPARATIDE) will accelerate radiographic evidence of fracture healing and speed functional recovery. If this hypothesis holds true, it would lead to a change in clinical practice and an improved quality of care for pelvic fracture patients. Evidence of an impact on the healing of pelvic fractures may also extend to a potential to improve healing of other osteoporosis-related fractures. In the planned trial the investigators will recruit women and men with acute pelvic fractures and address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if ABALOPARATIDE in addition to standard care versus placebo and standard care:
- Results in evidence of more complete cortical bridging at 3 months using focus CT to reduce radiation exposure from CT scans (primary outcome).
- 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).
- Leads more to a more rapidly improved functional outcome using measures to assess lower extremity function (Continuous Summary Physical Performance Score and Timed Up and Go- secondary outcomes).
Although the primary analysis will be based on data from 0 to 3 months, whether the benefit of ABALOPARATIDE on fracture healing wanes over time is unclear, making a longer follow-up important to extend knowledge on the persistence of early ABALOPARATIDE effect on these outcomes. Therefore, the investigators will extend this study 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.
If ABALOPARATIDE 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 ABALOPARATIDE for treatment of other osteoporotic fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment with randomization
| Arm | Type | Receives |
|---|---|---|
| abaloparatide prefilled syringe | Active comparator | Drug: Abaloparatide 80 micrograms per Pen doseAbaloparatide-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 prefilled syringe | Placebo comparator | Drug: Placebo prefilled injector penFor 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- Persons unable to complete the NRS and other surveys based on assessment by the study doctor.
- Previously (prior to fracture) non-ambulatory subjects
- Exclusion criteria related to contraindication or intolerance to ABALOPARATIDE:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abaloparatide 80 micrograms per Pen doseAlso: Tymlosprefilled injector pen to deliver 80 micrograms daily subcutaneously | Drug | abaloparatide prefilled syringe |
| Placebo prefilled injector penAlso: placeboprefilled injector pen to deliver inactive solution daily subcutaneously | Drug | Placebo prefilled syringe |
Primary outcome
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.
6 secondary outcomes
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
Time frame: 8 weeks
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Participant (percent) reporting narcotic use for pain
Time frame: 8 weeks
Efficacy measure of the time for participants to complete the Timed Up and Go Test.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 22310957Prieto-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.
- Background: PubMed 10912847Kannus 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.
- Background: PubMed 26418971Andrich 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.
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- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeri W Nieves, PhD principal investigator
Hospital for Special Surgery, New York
Joseph Lane, MD principal investigator
Hospital for Special Surgery, New York
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abaloparatide 80 micrograms per Pen dose in people with Fracture of Pelvis (Disorder), run by Hospital for Special Surgery, New York at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy for fracture healing- Measured by participant cortical bridging scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249232, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.