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Forteo ® (teriparatide injection)
20-mcg daily dose in a 2.4-mL prefilled delivery device
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What was the effect of FORTEO® (teriparatide injection) on BMD in the pivotal clinical trials?
Teriparatide 20 mcg/day significantly increased lumbar spine, femoral neck, and total hip BMD from baseline in PMW with osteoporosis and patients with GIO. In men with primary or hypogonadal osteoporosis, it increased lumbar spine and femoral neck BMD.
Detailed Information
The following sections provide a brief overview of the effect of teriparatide 20 mcg/day on bone mineral density (BMD) in the pivotal clinical trials.
Effects of Teriparatide on Bone Mineral Density in Postmenopausal Women With Osteoporosis
Results from a last observation carried forward (LOCF) analysis showed that teriparatide significantly increased baseline to endpoint BMD at the lumbar spine, femoral neck, and total hip in postmenopausal women (PMW) with osteoporosis (Mean Percentage Change in BMD From Baseline to Endpoint in Postmenopausal Women With Osteoporosis Treated With Teriparatide or Placebo for a Median of 19 Months).1
|
Teriparatide n=541 |
Placebo n=544 |
LS BMD |
9.7%b |
1.1% |
FN BMD |
2.8%c |
-0.7% |
TH BMD |
2.6%c |
-1.0% |
Abbreviations: BMD = bone mineral density; FN = femoral neck; LS = lumbar spine; TH = total hip.
aIntent-to-treat analysis, last observation carried forward.
bp<.001 compared with placebo.
cp<.05 compared with placebo.
In a subset of women for whom data were available at every time point (3, 6, 12, and 18 months; n=129), teriparatide significantly increased lumbar spine BMD by 3.9% at 3 months of treatment and 11.8% at 18 months.2
Effects of Teriparatide on Bone Mineral Density in Men With Primary or Hypogonadal Osteoporosis
In men with primary or hypogonadal osteoporosis treated with teriparatide, significant increases in lumbar spine BMD were seen at 3 months and continued throughout the treatment period (median 10 months).1
LOCF analysis showed that teriparatide treatment for a median of 10 months caused a significantly greater increase in BMD compared with placebo from baseline to endpoint at the
- lumber spine (5.9% vs 0.5%, p<.001), and
- femoral neck (1.5% vs 0.3%, p<.05).1
There was no significant difference observed in the change from baseline to endpoint in total hip BMD.1
Effects of Teriparatide on Bone Mineral Density in Men and Women With Glucocorticoid-Induced Osteoporosis
In patients with glucocorticoid-induced osteoporosis, teriparatide significantly increased BMD at the lumbar spine, femoral neck, and total hip by 7.2%, 3.7%, and 3.6%, respectively, from baseline to the 18-month endpoint (p<.001 at all sites).1
Enclosed Prescribing Information
References
1Forteo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 04, 2023