FORTEO (teriparatide [rDNA origin] injection) Efficacy: In a median of 19 months, FORTEO significantly reduced the risk of vertebral and nonvertebral fractures*†2
Number needed to treat11= 11
n=448 (placebo); with ≥1 new vertebral fracture(s): 64
n=444 (FORTEO); with ≥1 new vertebral fracture(s): 22
(RR, 0.35; 95% CI, 0.22—0.55)
(AR: placebo 14.3%; FORTEO 5.0%, P≤0.001)
Number needed to treat12 = 34
n=544 (placebo); with ≥1 new nonvertebral fracture(s): 30
n=541 (FORTEO); with ≥1 new nonvertebral fracture(s): 14
(RR, 0.47; 95% CI, 0.25—0.88)
(AR: placebo 5.5%; FORTEO 2.6%, P<0.05)
Approximately 90% of patients in the Fracture Prevention Trial had a prevalent vertebral fracture2
*Fracture Prevention Trial: Multicenter, prospective, double-blind trial of FORTEO 20 mcg/day (n=541) vs. placebo (n=544). 1,637 postmenopausal women with osteoporosis, of whom 90% had a prevalent vertebral fracture at baseline, were evaluated. Mean age: 69. Median duration of exposure to therapy: 19 months (maximum 24 months). All received 1,000 mg/day of calcium and 400-1,200 IU/day of vitamin D.2,9
**A post hoc analysis of the vertebral fracture data from the Fracture Prevention Trial using a combination of quantititive vertebral morphometry measurements (QM) and qualitative visual semiquantitative (SQ) grading to assess lateral spine radiographs showed that vertebral fracture relative risk reduction for FORTEO was 84%§14
§A post hoc analysis was conducted on a subset of 892 women who had a baseline and enpoint spine radiograph (FORTEO n-444, placebo n=448). Primary analysis was the comparison of the proportions of women with new vertebral fractures as defined by the combination of group-blinded quantitative vertebral morphometry measurements and confirmation of the results of qualitative visual semiquantitative grading by Neer et al, using a Fishers’ exact test.14
†Nonvertebral fracture risk reduction was obtained from pooling data from the following sites: ankle/foot, hip, humerus, pelvis, ribs, wrist, and other sites.
‡Fragility fractures were defined as fractures occurring with minimal trauma (eg, falling from standing height).
FORTEO Select Safety Information
In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. The clinical relevance of the rat osteosarcoma finding to humans is unknown.
FORTEO may help increase bone mineral density
In postmenopausal women with osteoporosis treated with FORTEO2*:
- Hip and femoral neck BMD were significantly increased at endpoint
- 96% had an increase in lumbar spine BMD
- Lumbar spine BMD was significantly increased above baseline at 3 months through end point
- In a population of patients for whom data were available at every time point (FORTEO [n=129], placebo [n=137]), FORTEO significantly increased lumbar spine BMD by 11.8% at 18 months†10
- In a separate analysis of the data using the last observation carried forward (FORTEO [n=541], placebo [n=544]), FORTEO significantly increased lumbar spine BMD by 9.7%‡2
* Fracture Prevention Trial: Multicenter, prospective, double-blind trial of FORTEO 20 mcg/day (n=541) vs. placebo (n=544). 1,637 postmenopausal women with osteoporosis, of whom 90% had a prevalent vertebral fracture at baseline, were evaluated. Mean age: 69. Median duration of exposure to therapy: 19 months (maximum 24 months). All received 1,000 mg/day of calcium and 400—1,200 IU/day of vitamin D.2,9
†P‹0.001 for FORTEO vs. placebo at each postbaseline time point.
‡P‹0.001 for FORTEO compared with placebo at endpoint.
FORTEO Select Safety Information
Prescribe FORTEO only for patients for whom the potential benefits are considered to outweigh the potential risks. FORTEO should not be prescribed for patients at increased baseline risk for osteosarcoma, including those with Paget’s disease of bone, unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy. Additionally, patients with bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or pre-existing hypercalcemia should not receive FORTEO.
VERO – The first trial in osteoporosis research that has shown a significant vertebral fracture risk reduction outcome as a primary endpoint in a head-to-head, active comparator study.13
FORTEO® (teriparatide) demonstrated a statistically significant reduction in the incidence of new vertebral fragility fractures at 24 months vs a bisphosphonate.13
The effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO) trial. A multicenter, double-blind, double-dummy, randomized controlled trial of teriparatide (FORTEO) 20mcg/day (n=680) vs. risedronate 35mg once weekly (n=680). 1,366 postmenopausal women with severe osteoporosis (≥1 prevalent vertebral fracture at baseline) of whom 72.1% received at least one prior osteoporosis medication, most commonly a bisphosphonate, were enrolled. The mean age was 72.1. Median (IRQ) duration of therapy was 23.9 (18.8 to 24.1) months for FORTEO and 23.7 (22.8 to 24.0) months for risedronate. All patients received 500 - 1,000 mg/day of calcium and 400 - 800 IU/day of vitamin D.13
There were no statistically significant differences between the 2 groups in the proportion of patients with 1 or more treatment-emergent adverse events in VERO: ≥1 adverse event (72.8% FORTEO vs. 73.5% risedronate).13
The Fracture Prevention Trial, FORTEO’s pivotal trial, showed that, in a median of 19 months, FORTEO 20 mcg/day significantly reduced the risk of vertebral fracture by 9.3% ARR or 65% RRR vs placebo [FORTEO n=444, Placebo n=448]. Mean age: 69; 90% had prevalent vertebral fracture at baseline; all received 1,000 mg/day calcium and 400-1,200 IU/day vitamin D.9
The most common adverse reactions in FORTEO clinical trials include: arthralgia (10.1% FORTEO vs. 8.4% placebo), pain (21.3% FORTEO vs. 20.5% placebo), and nausea (8.5% FORTEO vs. 6.7% placebo).9
2. FORTEO package insert. Indianapolis, IN: Eli Lilly and Company; 2012., 9. Neer RM, et al. N Engl J Med. 2001;344:1434-1441., 10. Data on file, Lilly Research Laboratories (FOR20090922A)., 11. Data on file, Lilly Research Laboratories (FOR20110608A)., 12. Data on file, Lilly Research Laboratories (FOR20111019A)., 13. Kendler DL et al. The Lancet 2017. DOI: https://doi.org/10.1016/S0140-6736(17)32137-2, 14. Prevrhal S. Curr Med Res Opin. 2009;25:921-928.