Bone Abstracts

It has been previously reported that prolonged treatment with rhPTH(1–34) or rhPTH(1–84) in rats is associated with the development of bone neoplasms including osteosarcomas. However, to date there has been no evidence of an increased osteosarcoma risk of in patients treated with rhPTH(1–34) or rhPTH(1–84), or in diseases associated with chronic PTH elevation. Abaloparatide (ABL) is a novel analog of PTHrP(1–34) currently being developed as a treatment...

Background: Treatments that result in greater increases in bone mass of normal quality by increasing bone formation rather than decreasing resorption are needed. Abaloparatide is a synthetic analog of PTHrP1-34 that has shown strong efficacy to increase bone mass and bone strength in animals. We conducted two phase 2 placebo-controlled studies both of which included abaloparatide 80 μg sc daily (ABL) in postmenopausal women with osteoporosis. Study 1 also inclu...

see PP352....

Abaloparatide (ABL) is a novel analog of hPTHrP (1–34) in clinical development for treatment of osteoporosis. This study evaluated the long-term effects of ABL on BMD and bone strength in aged osteopenic, ovariectomized (OVX) monkeys. Four groups of ≥9-year-old female cynomolgus monkeys underwent OVX and one group underwent Sham surgery. After a 9-month bone depletion period, increases in bone markers and decreases in BMD by DXA and pQCT were observed for OVX groups...

A randomized, placebo-controlled phase 2 study evaluated the safety and efficacy of BA058, an analog of hPTHrP(1–34), in postmenopausal women with severe osteoporosis. 221 patients were randomized to received BA058 20, 40, and 80 μg, placebo or teriparatide (TP) 20 μg, by daily s.c. injection. 184 (83%) patients completed an initial 24 weeks of treatment. The mean percent change in lumbar spine BMD at 24 weeks was 1.6% with placebo, 6.7% with BA058 80 μg, a...

see PP351....

Abaloparatide (BA058) is a synthetic analog of PTHrP1–34 which greatly increases bone mass and bone strength with preservation of normal bone quality in animal models of osteoporosis. Daily s.c. abaloparatide (ABLSC) at doses of up to 80 μg daily in postmenopausal women with osteoporosis for up to 48 weeks were associated with increases in spine and femoral neck BMD of up to 12.9 and 4.1% respectively and good safety and tolerability. The increa...

BA058 is being developed as an anabolic therapy for the treatment of osteoporosis. Daily BA058 SC injection has produced promising safety and efficacy results in early clinical studies, and is currently enrolling in a Phase 3 fracture prevention study. There is, however, a significant need for an alternative to injection that improves patient convenience and compliance. We have investigated the use of a solid Microstructured Transdermal System (3M) for transdermal (TD) deliver...