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Amgen Presents Several Sub-Analyses At ASBMR From The Ongoing Open-Label Extension Study Of The Pivotal Phase 3 Prolia Fracture Trial
"The data presented provide additional insight into the long-term clinical profile of Prolia," said
SELECTED ABSTRACTS OF INTEREST INCLUDE:
Abstracts are available on the ASBMR website at www.asbmr.org and updated data have been presented at the meeting.
- Relationship Between Changes in Bone Mineral Density (BMD) and Incidence of Fracture with 6 Years of Denosumab Treatment
Lead Author: PD Miller, M.D.,
University of Colorado Health Science Centerand Colorado Center for Bone Research
(Abstract No. 1099; Oral Presentation;
- Nearly all women who received six years of denosumab treatment showed gains in BMD at the lumbar spine, total hip or femoral neck: 95 percent demonstrated gains of greater than six percent at any of these sites. The risk for new or worsening vertebral fracture and nonvertebral fracture decreased with increasing percentage change in total hip BMD over six years.
- Long-term Denosumab Treatment Maintains Low Incidence of Fracture in Postmenopausal Women >75 Years with Osteoporosis
Lead Author: S. Papapoulos, M.D.,
Leiden University Medical Center
(Abstract No. FR0391; Plenary Poster;
- Despite the increase in age of the patients during the pivotal Phase 3 fracture study extension, denosumab treatment continued to be associated with a low incidence of new vertebral, nonvertebral and hip fractures.
- The incidence of fractures in patients > 75 years in the study extension was similar to what was originally observed in women older than 75 years in the original pivotal Phase 3 fracture study.
- Effects of 5 Years of Denosumab on Bone Histology and Histomorphometry: FREEDOM Study Extension
Lead Author: JP Brown, M.D.,
Laval Universityand CHUQ
(Abstract No. 1134; Oral Presentation;
- Denosumab treatment through five years resulted in normal bone quality with reduced bone turnover, consistent with its mechanism of action.
Osteoporosis, which causes more than 2 million bone breaks each year, is a growing concern among health professionals as more than 40 million people are either living with, or at risk for developing, the disease.
In 2005, osteoporosis-related fractures were responsible for an estimated
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients with prostate cancer, Prolia reduced the incidence of vertebral fractures.
Prolia is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia is approved in the
Prolia is approved in the U.S.,
Prolia is administered as a single subcutaneous injection of 60 mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit: www.prolia.com.
Important U.S. Safety Information
Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Prolia is contraindicated in women who are pregnant and may cause fetal harm. Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Patients receiving Prolia should not receive XGEVA® (denosumab), as both Prolia and XGEVA contain the same active ingredient, denosumab.
Hypocalcemia may worsen with the use of Prolia, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D. In the pivotal Phase 3 study of women with postmenopausal osteoporosis (n=7808), serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the Prolia-treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.
In clinical trials in women with postmenopausal osteoporosis, Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical fractures and delayed fracture healing. ONJ and atypical femoral fractures have been reported in patients with Prolia. Patients should be monitored for these adverse outcomes. The most common adverse reactions (>5 percent and more common than placebo) in patients with postmenopausal osteoporosis were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia and cystitis. The most common adverse reactions in men with osteoporosis were back pain, arthralgia and nasopharyngitis. Pancreatitis has also been reported with Prolia in patients with osteoporosis. The most common (per patient incidence >10 percent) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
The extent to which Prolia is present in seminal fluid is unknown. For men treated with Prolia, there is a potential for fetal exposure if the sexual partner is pregnant. While the risk is likely to be low, patients should be advised of this potential risk.
Important EU Safety Information
The most common adverse reactions with Prolia were urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash and pain in extremity. The most serious adverse reactions were those of skin infections, predominantly cellulitis, reported more commonly in the Prolia group compared with placebo (0.4 percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions of skin infection were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in patients with prostate cancer receiving ADT, an imbalance in cataract adverse events was observed with Prolia compared with placebo (4.7 percent vs. 1.2 percent placebo). No imbalance in cataract adverse events was observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
Prolia may lead to hypocalcaemia. Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. ONJ has been reported rarely in clinical studies in patients receiving denosumab at a dose of 60 mg every 6 months for osteoporosis. In the post-marketing setting, rare events of drug-related hypersensitivity have been reported in patients receiving Prolia.
Denosumab Commercialization Collaborations
In addition, GlaxoSmithKline will register and commercialize denosumab for all indications in countries where
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