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Osteoporosis Therapy

abaloparatide for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Jason Mendler, M.D.
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age equal to or greater than 18
MDS patients previously treated with disease-modifying chemotherapy (i.e. azacitidine, decitabine, lenalidomide, intensive chemotherapy, and/or an investigational agent) are eligible irrespective of IPSS-R score.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights

Study Summary

This trial is testing a new treatment for Myelodysplastic Syndromes (MDS) that combines abaloparatide with bevacizumab. The goal is to find out if it is safe and effective, and if it improves patients' quality of life.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who experience a therapy-limiting Toxicity (TLT)
Secondary outcome measures
Proportion of patients who responded to therapy

Side effects data

From 2021 Phase 3 trial • 511 Patients • NCT04064411
47%
Injection site erythema
32%
Injection site pain
19%
Injection site pruritus
19%
Injection site swelling
16%
Headache
14%
Nausea
14%
Injection site bruising
12%
Injection site haemorrhage
12%
Injection site oedema
10%
Back pain
9%
Dizziness
8%
Arthralgia
8%
Orthostatic hypotension
8%
Urinary tract infection
7%
COVID-19
7%
Pain in extremity
7%
Palpitations
6%
Hypertension
6%
Application site erythema
6%
Application site pain
6%
Fatigue
4%
Application site pruritus
2%
Administration site erythema
2%
Application site swelling
2%
Hypercalciuria
1%
COVID-19 pneumonia
1%
Pleural effusion
1%
Application site haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abaloparatide-SC
Abaloparatide-sMTS

Trial Design

1Treatment groups
Experimental Treatment
Group I: abaloparatide and bevacizumab treatmentExperimental Treatment2 Interventions
In cycle 1, patients will be treated with single-agent, subcutaneous (SQ) abaloparatide at a dose of 80 mcg/day for 28 days. In cycles 2-4 (each cycle is 28 days), patients will be treated with SQ abaloparatide at a dose of 80 mcg/day and intravenous (IV) bevacizumab 5 mg/kg on days 1 and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
abaloparatide
2019
Completed Phase 3
~540
bevacizumab
2002
Completed Phase 3
~3360

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
833 Previous Clinical Trials
518,124 Total Patients Enrolled
Jason Mendler, M.D.Principal Investigator - University of Rochester
Strong Memorial Hospital
University Of Rochester School Of Medical & Dentistry (Medical School)
Strong Mem Hsp U Rochester (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has abaloparatide been tested in any other research trials previously?

"At this time, there are 361 ongoing trials related to abaloparatide, with 89 of them in Phase 3. The majority of these studies originate from Taibei, Taiwan; however there is research being conducted at 17027 different locations worldwide."

Answered by AI

Is recruitment still ongoing for this medical experiment?

"According to data hosted on clinicaltrials.gov,this medical study has completed its recruitment process and is not presently accepting new patients; the original posting was February 14th 2019 and the last update occurred August 10th 2022. However, there are 1969 other clinical trials actively recruiting individuals at this time."

Answered by AI

How many people are currently participating in this clinical trial?

"Unfortunately, the recruitment process for this trial concluded on August 10th 2022. If you are searching for alternative clinical trials, 1608 studies involving patients with leukemia, myelomonocytic or chronic conditions and 361 studies dealing with abaloparatide are currently open to participants."

Answered by AI

Is abaloparatide a risk-free option for individuals?

"Abaloparatide has been reviewed by our team at Power and deemed to have a safety score of 1 due to the lack of evidence supporting its efficacy in Phase 1 trials."

Answered by AI

To what types of ailments is abaloparatide traditionally allocated?

"Abaloparatide is typically used to battle cancer, including recurrent platinum sensitive primary peritoneal cancer, stage IV epithelial ovarian cancer post-surgical resection, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI
~3 spots leftby Mar 2025