Teriparatide + Zoledronic Acid Does Not Reduce Fracture Risk in Osteogenesis Imperfecta

In continuation of my update on Teriparatide and  Zoledronic Acid

Zoledronic Acid

Teriparatide

Among adults with osteogenesis imperfecta, teriparatide plus zoledronic acid does not reduce fracture risk compared with standard care, according to a study published online May 14 in the Journal of the American Medical Association.

Jannie Dahl Hald, Ph.D., from Aarhus University Hospital in Denmark, and colleagues examined whether the parathyroid hormone analogue teriparatide followed by zoledronic acid reduces the risk for fractures in adults with osteogenesis imperfecta in a multicenter randomized clinical trial. Participants were randomly assigned to receive 20 μg of teriparatide daily by subcutaneous injection for two years, followed by 5 mg zoledronic acid infusion (176 participants), or to standard care, in which bisphosphonates and other bone-targeted medicines could be used (174 participants).

Most of the participants had type I osteogenesis imperfecta caused by pathogenic variants in the type 1 collagen genes. The researchers found that 36.9 and 36.4 percent of patients in the teriparatide plus zoledronic acid group and the standard care group, respectively, had incident fractures. There was significantly more of an increase in lumbar spine and total hip bone mineral density with teriparatide plus zoledronic acid than standard care. Teriparatide plus zoledronic acid was favored in several quality-of-life measures. The groups reported similar adverse events.

"We have been using drugs to increase bone density for decades in the hope that they might prevent fractures but the TOPaZ trial clearly shows that these medicines simply do not work," lead author Stuart Ralston, M.D., from the University of Edinburgh Institute of Genetics and Cancer in the United Kingdom, said in a statement.

Ref : https://jamanetwork.com/journals/jama/fullarticle/2849063

https://en.wikipedia.org/wiki/Zoledronic_acid

https://en.wikipedia.org/wiki/Teriparatide

Teriparatide + Zoledronic Acid Does Not Reduce Fracture Risk in Osteogenesis Imperfecta - Drugs.com MedNews

FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis

In continuation of my update on teriparatide

Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA) has approved the new drug application (“NDA”) for Bonsity (PF708) submitted under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture. 

“The FDA’s approval of Bonsity marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.

Pfenex is also asking the FDA to designate PF708 as therapeutically equivalent (“A” rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states. To further support an “A” rating, Pfenex is conducting a comparative human factors study between PF708 and Forteo as requested by FDA. Pfenex anticipates submitting the final study report to the FDA as early as the second half of October 2019 and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF708.

“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market. To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating,” concluded Mr. Schimmelpennink.

https://en.wikipedia.org/wiki/Teriparatide

Steroid-induced osteoporosis can now be treated with Teriparatide

Steroid-induced osteoporosis can now be treated with Teriparatide

Investigational drug abaloparatide-SC may help increase bone mineral density in postmenopausal women

 

The investigational drug abaloparatide-SC (subcutaneous) may help increase bone mineral density in postmenopausal women and reduce their risk of fracture, new industry-sponsored research suggests. The results of the subgroup analysis within the ACTIVE clinical trial will be presented Friday, April 1, at ENDO 2016, the annual meeting of the Endocrine Society in Boston.

"Abaloparatide-SC increased bone mineral density and reduced the risk of vertebral and nonvertebral fractures consistently in postmenopausal women with osteoporosis regardless of their baseline patient characteristics, including age, bone mineral density, and whether or not they had prior fractures," said lead study author Felicia Cosman, MD, endocrinologist and osteoporosis specialist at Helen Hayes Hospital in West Haverstraw, New York, and professor of clinical medicine at Columbia University in New York City.

"If approved by the Food and Drug Administration (FDA), abaloparatide-SC may have the potential to reduce the risk of fractures in postmenopausal women with osteoporosis across a broad range of patient characteristics," said Cosman, who is also a consultant to Radius Health, Inc., in Waltham, Massachusetts.

The researchers investigated patients enrolled in the randomized, double-blind, multinational phase 3 ACTIVE trial to evaluate the efficacy and safety of 80 micrograms of abaloparatide-SC in preventing fractures in otherwise healthy, ambulatory, postmenopausal women with osteoporosis. Overall, 2,463 patient between 49 and 86 years of age were randomized to take one of three medications for 18 months: 80 micrograms of abaloparatide-SC, 20 micrograms of subcutaneous teriparatide (an FDA-approved prescription drug known to increase bone density and strength), or placebo.

Investigational drug abaloparatide-SC may help increase bone mineral density in postmenopausal women