Tymlos (abaloparatide) / Radius, Ipsen, Teijin, Pharmbio - LARVOL DELTA

Abaloparatide Before Total Knee Arthroplasty (clinicaltrials.gov) - P4 | N=58 | Completed | Sponsor: University of Wisconsin, Madison | Active, not recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

Abaloparatide and Pelvic Fracture Healing: A Phase 2 Randomized Controlled Trial (AAOS 2025) - P2 | "Abaloparatide (Tymlos) is currently FDA approved for the treatment of osteoporosis in the US... In this small randomized, blinded study, there was a trend toward improvement in radiographic healing (CT at 3 months) in ABL vs. PBO whether looking at healing of individual fractures or healing by person. However, there was significant benefit of ABL vs."

Clinical • P2 data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial • Osteoporosis • Rheumatology

PTH Analog Type II Odontoid Fracture (clinicaltrials.gov) - P2 | N=22 | Terminated | Sponsor: David Lunardini | Recruiting ➔ Terminated; Study terminated early due to low recruitment rate.

Trial termination • Musculoskeletal Diseases • Orthopedics

Drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Osteoporosis • Rheumatology

Comparison table: Some drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Osteoporosis • Rheumatology

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone (clinicaltrials.gov) - P4 | N=70 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Jan 2023 ➔ Jun 2026 | Trial primary completion date: Jul 2022 ➔ Apr 2026

Trial completion date • Trial primary completion date • Osteoporosis • Rheumatology

Abaloparatide and Pelvic Fracture Healing (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Hospital for Special Surgery, New York | Active, not recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases • Orthopedics

Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Hospital for Special Surgery, New York | N=72 ➔ 96 | Trial completion date: Oct 2024 ➔ Sep 2026 | Trial primary completion date: Oct 2024 ➔ Sep 2026

Enrollment change • Surgery • Trial completion date • Trial primary completion date

Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women (clinicaltrials.gov) - P=N/A | N=22054 | Completed | Sponsor: Radius Health, Inc. | Active, not recruiting ➔ Completed | N=16000 ➔ 22054

Enrollment change • Real-world • Real-world effectiveness • Real-world evidence • Trial completion • Cardiovascular • Osteoporosis • Rheumatology

Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women Receiving Initial Spinal Fusion Surgery (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Jan 2024 ➔ Oct 2024 | Trial primary completion date: Jan 2024 ➔ Oct 2024

Surgery • Trial completion date • Trial primary completion date

Abaloparatide and Pelvic Fracture Healing (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Hospital for Special Surgery, New York | Recruiting ➔ Active, not recruiting | N=78 ➔ 48 | Trial primary completion date: Jan 2024 ➔ May 2024

Enrollment change • Enrollment closed • Trial primary completion date • Musculoskeletal Diseases • Orthopedics

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe. (PubMed, Ther Innov Regul Sci) - "Prior to the planned resubmission in the EU, national Scientific Advice (SA) was sought on the proposed clinical program, specifically on the relevance of Real-World Data (RWD) derived from an observational study to support and complement the efficacy and safety data already available from prospective randomized clinical trials. This case study demonstrates successful use of RWE to address a previously identified gap raised by the CHMP during the review of an earlier MAA, which led to the approval of Eladynos for the treatment of osteoporosis in the EU."

Clinical • HEOR • Journal • Real-world • Real-world evidence • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

The Safety and Efficacy of Abaloparatide on Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis. (PubMed, Clin Ther) - "Abaloparatide has a protective effect on women with postmenopausal osteoporosis. It could reduce their risk for vertebral fracture; increase their BMD of the lumbar spine, femoral neck, and hip; and alleviate symptoms and complications of postmenopausal osteoporosis with considerable safety. Limitations of this study include not searching the gray literature and not performing a subgroup analysis. PROSPERO Registration No.: CRD42022370944."

Journal • Retrospective data • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • COL1A2

Abaloparatide Before Total Knee Arthroplasty (clinicaltrials.gov) - P4 | N=58 | Active, not recruiting | Sponsor: University of Wisconsin, Madison

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=60 | Not yet recruiting | Sponsor: Pharmbio Korea Co., Ltd.

New P3 trial • Osteoporosis • Rheumatology

Abaloparatide Before Total Knee Arthroplasty (clinicaltrials.gov) - P4 | N=58 | Active, not recruiting | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Active, not recruiting

Enrollment closed • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

Efficacy and safety of transdermal abaloparatide in postmenopausal women with osteoporosis: a randomized study. (PubMed, J Bone Miner Res) - P3 | "Few new clinical fractures occurred in either group. Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups."

Journal • Dermatology • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Abaloparatide Before Total Knee Arthroplasty (clinicaltrials.gov) - P4 | N=58 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology

A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: University of Rochester | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2022

Trial completion • Trial completion date • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Abaloparatide and Pelvic Fracture Healing (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics

Osteoporosis: A Review of Novel Agents. (PubMed, Orthop Nurs) - "This article summarizes two specific agents that were approved by the Food and Drug Administration within the last few years: abaloparatide (Tymlos) and romosozumab (Evenity). This article also highlights the crucial role that nursing staff may play in the management of osteoporosis."

Journal • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

The Efficacy and Safety of Abaloparatide-SC in Men with Osteoporosis: A Randomized Clinical Trial. (PubMed, J Bone Miner Res) - P3 | "During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies. These results suggest abaloparatide can be considered as an effective anabolic treatment option for men with osteoporosis."

Clinical • Journal • Cardiovascular • Hypertension • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoporosis • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Abaloparatide Increases Lumbar Spine and Hip BMD in Japanese Patients With Osteoporosis: The Phase 3 ACTIVE-J Study. (PubMed, J Clin Endocrinol Metab) - "In Japanese patients with postmenopausal and male osteoporosis with high fracture risk, abaloparatide for 78 weeks robustly increased LS, TH, and FN BMDs, suggesting a similar efficacy in Japanese patients vs the ACTIVE study population."

Clinical • Journal • P3 data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: University of Rochester | Trial completion date: Jun 2022 ➔ Dec 2022

Trial completion date • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology