"These findings are especially important because they show romosozumab provided significant improvements in hip bone strength in a population that remained at high risk of fracture despite bisphosphonate therapy," said
The trial included 436 women, averaging 72 years of age, with postmenopausal osteoporosis, a history of non-vertebral fracture after the age of 50, or vertebral fracture and treatment with bisphosphonate therapy for a minimum of three years prior to transitioning to romosozumab or teriparatide therapy. The women were randomly assigned to receive either subcutaneous romosozumab 210 mg once monthly (n=218) or subcutaneous teriparatide 20 mcg daily for 12 months (n=218).
The results showed that the percent change from baseline in BMD at the total hip through month 12 (the primary endpoint, an average of the percent change from baseline at month six and 12), was significantly greater with romosozumab compared with teriparatide: 2.6 percent versus –0.6 percent, respectively (p<0.0001), for a mean difference between the two groups of 3.2 percent (p<0.0001). The measurement was based on the standard method of dual-energy x-ray absorptiometry (DXA).
For the secondary endpoints, patients treated with romosozumab had significantly larger increases from baseline in BMD and strength compared with those taking teriparatide, with mean differences ranging from 3.1 percent to 4.6 percent (all p-values <0.0001):
|
Percent change from baseline |
Romosozumab |
Teriparatide |
Mean Difference |
|
Total hip BMD changes by DXA at six months |
2.3 percent |
–0.8 percent |
3.1 percent |
|
Total hip BMD changes by DXA at 12 months |
2.9 percent |
–0.5 percent |
3.4 percent |
|
Femoral neck BMD changes by DXA at six months |
2.1 percent |
–1.1 percent |
3.2 percent |
|
Femoral neck BMD changes by DXA at 12 months |
3.2 percent |
–0.2 percent |
3.4 percent |
|
Lumbar spine BMD changes by DXA at six months |
7.2 percent |
3.5 percent |
3.8 percent |
|
Lumbar spine BMD changes by DXA at 12 months |
9.8 percent |
5.4 percent |
4.4 percent |
|
Total hip integral BMD changes by quantitative computed tomography (QCT) at six months |
2.3 percent |
–0.8 percent |
3.1 percent |
|
Total hip integral BMD changes by QCT at 12 months |
3.4 percent |
–0.2 percent |
3.6 percent |
|
Total hip cortical BMD changes by QCT at six months |
0.7 percent |
–2.7 percent |
3.4 percent |
|
Total hip cortical BMD changes by QCT at 12 months |
1.1 percent |
–3.6 percent |
4.6 percent |
|
Total hip estimated strength by finite element analysis (FEA) at six months |
2.1 percent |
–1.0 percent |
3.1 percent |
|
Total hip estimated strength by FEA at 12 months |
2.5 percent |
–0.7 percent |
3.2 percent |
The overall incidence of adverse events was generally balanced between the two study arms. Incidence of all adverse events in patients treated with romosozumab was 75.2 percent compared to 69.2 percent with teriparatide. Serious adverse events occurred in 7.8 percent of patients treated with romosozumab compared to 10.7 percent for teriparatide. Adverse events reported in the romosozumab arm greater than or equal to 10 percent of patients were arthralgia and nasopharyngitis. Injection site reactions were reported in 7.8 percent.
About Romosozumab
Romosozumab is an investigational bone-forming agent and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis.
About the STRUCTURE study (NCT01796301)
STRUCTURE (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy) was a Phase 3, multi-center, international, randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. The trial included 436 postmenopausal women averaging 72 years of age who had postmenopausal osteoporosis and a history of bone fracture; patients were treated with bisphosphonate therapy for a minimum of three years prior to screening, with treatment with alendronate (70 mg weekly or equivalent) during the year immediately prior to screening. The women received daily calcium and vitamin D and were randomly assigned to receive either subcutaneous romosozumab 210 mg once monthly (n=218), administered by a healthcare professional, or self-administered subcutaneous teriparatide 20 mcg daily for 12 months (n=218).
The primary endpoint was percent change from baseline in total hip BMD by DXA through month 12 (average of the changes at months six and 12). Key secondary endpoints included percent change from baseline at months six and 12 in total hip BMD by DXA; hip integral and cortical BMD by quantitative computed tomography (QCT), a method to measure BMD changes in three dimensions; and estimated hip strength by finite element analysis (FEA). FEA is a validated method that utilizes QCT scans to simulate compression overload to estimate vertebral strength, and a sideways fall to estimate femoral strength. Other secondary endpoints included lumbar spine and femoral neck BMD by DXA at months six and 12.
About Osteoporosis
Osteoporosis affects many women after menopause as their ability to form new bone cannot counter balance the rate at which bone is being removed.1,2 This bone loss leads to weakened bones over time, increasing the potential for a break.3
It is estimated that one in three women over the age of 50 will experience an osteoporotic fracture.4,5 Patients who experience an osteoporosis-related fracture are twice as likely to experience a future fracture.6
About Amgen
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
About UCB
UCB,
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There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
CONTACT:
CONTACT: UCB, Brussels
T +32.2.559.9178, france.nivelle@ucb.com
T+32.2.559.92.64, Laurent.schots@ucb.com
T +32.2.559.94.14, antje.witte@ucb.com
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