New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis
- Category: Proteins and Peptides
- Published on Friday, 10 November 2017 08:46
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First trial in osteoporosis research that has shown a significant fracture reduction outcome as a primary endpoint in a head-to-head, active-drug comparative study.
INDIANAPOLIS, IN, USA I November 9, 2017 I Eli Lilly and Company (NYSE: LLY) today announced new data showing that treatment with FORTEO® for 24 months was associated with significantly fewer vertebral and clinical fractures (a composite of painful vertebral and non-vertebral fractures) compared with risedronate, a widely used oral bisphosphonate, in postmenopausal women with severe osteoporosis in the VERO clinical trial. Study results are published in the November 9 issue of The Lancet.1
Results from the study's primary endpoint showed that at 24 months, fewer patients taking FORTEO® had new vertebral fractures as compared to patients taking risedronate (5.4% vs. 12.0%, p <0.0001).
The two year randomized, double-blind, double-dummy clinical trial compared subcutaneous daily teriparatide (20 μg) with oral weekly risedronate (35 mg) in 1,360 women with at least two moderate or one severe vertebral fracture and low bone mass.
"The VERO study data reinforces the efficacy of FORTEO® in reducing fractures and can help physicians make informed prescribing decisions," said David L. Kendler, Professor of Endocrinology in the University of British Columbia, Vancouver and first author of the article.
This is the first trial in osteoporosis research that has shown a significant fracture reduction outcome as a primary endpoint in a head-to-head, active-drug comparative study.
After 24 months of treatment:
- New vertebral fractures occurred in 5.4% of patients in the teriparatide group, as compared with 12.0% in the risedronate group after 24 months (a relative risk reduction of 56%; p<0.001).
- The reduction in new vertebral fractures with teriparatide was observed as early as 12 months of treatment, with 3.1% of patients in the teriparatide group compared with 6.0% in the risedronate group having had at least one new vertebral fracture (a relative risk reduction of 48%; p<0.05).
- New and worsening vertebral fractures occurred in 6.0% of the patients in the teriparatide group, as compared with 12.9% of the patients in the risedronate group (a relative risk reduction of 54%; p<0.001).
- Clinical fractures (a composite endpoint of non-vertebral plus painful vertebral fractures) occurred in 4.8% of patients in the teriparatide group, compared with 9.8% in the risedronate group (a relative risk reduction of 52%; p<0.001).
- No statistically significant difference between groups in the incidence of non-vertebral fractures was observed: non-vertebral fragility fractures occurred in 4.0% of patients in the teriparatide group and 6.1% in the risedronate group (p=0.10).
- There were no statistically significant differences between treatment groups in the change from baseline in back pain and quality of life, although both groups showed an improvement compared to baseline.
- Adverse events and safety laboratory findings were consistent with the known safety profile of each drug. More patients treated with teriparatide had at least one high value of serum calcium or uric acid, and lower levels of serum magnesium and vitamin D.
FORTEO® is a prescription medication used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones, or fractures.2 FORTEO® is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones, or fractures. FORTEO® can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
During the drug testing process, the medicine in FORTEO® caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took FORTEO®, and it is unknown if people who take FORTEO® have a higher chance of getting the disease. Before patients take FORTEO®, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy. For more information about FORTEO®, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.
About the Study "Effects of 24 months treatment of teriparatide compared with risedronate on new fractures in postmenopausal women with severe osteoporosis: a randomized, double-dummy, clinical trial" (Study B3D-EW-GHDW [VERO Study]) was a Phase 4, multinational, multicenter, prospective, randomized, parallel, active comparator, clinical trial.
The primary endpoint was the incidence of new vertebral fractures after two years assessed by quantitative morphometry. Secondary outcomes were clinical fractures, non-vertebral fractures, other spine fractures endpoints, height loss, back pain, quality of life (EQ-5D) and safety. Adverse events and safety laboratory findings were consistent with the known safety profile of each drug.
1,360 patients were randomized to receive either teriparatide 20 μg/day injection (FORTEO®) plus weekly oral placebo or oral risedronate 35 mg/week plus daily placebo injection for a 24-month, double-blind, double dummy treatment phase in study sites from 14 participant countries in Europe, North America (USA and Canada) and South America (Argentina and Brazil). Patients were postmenopausal women over 45 years of age with a BMD T-score <-1.5 standard deviations at the femoral neck, total hip or lumbar spine, and at least two moderate or one severe prevalent vertebral fragility fractures.
Overall, 72·1% of patients had received at least one prior osteoporosis medication, most commonly a bisphosphonate.
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1 The Lancet, Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomized controlled trial. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32137-2/fulltext?elsca1=tlxpr. Accessed November 9, 2017. 2 FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf
SOURCE: Eli Lilly