Bone efficacy

New Bone Formation

In postmenopausal women with osteoporosis at high risk for fracture

Only FORTEO Can Stimulate New Bone Formation

MicroCT images are of paired iliac crest bone biopsies at baseline and after 21 months of treatment with FORTEO. These biopsies are from a postmenopausal patient with a baseline T-score of –2.7 at the total hip who had a BMD response that was representative of the treatment group.1

*In a trial of 1,637 postmenopausal women given the study drug or placebo for a median duration of 19 months (maximum 24 months).

bone_biopsy

FORTEO strengthens bone by2,3:

  • Forming new bone on cortical and trabecular surfaces
  • Increasing skeletal mass
  • Overfilling resorption pits with new, normal quality bone and creating an additional layer over existing bone

1Data on file, Lilly Research Laboratories (FOR20070809A). Jiang Y, Zhao JJ, Mitlak BH, et al. Recombinant Human Parathyroid Hormone (1-34) [Teriparatide] Improves Both Cortical and Cancellous Bone Structure. J Bone Miner Res 2003;18:1932–1941
2N Engl J Med. 2001;344:1434-1441.
3FORTEO Prescribing Information PA005FSHK02.

In postmenopausal women with osteoporosis at high risk for fracture

FORTEO Increases BMD in as Little as 3 Months

Forteo

  • 3.9% increase seen with FORTEO at 3 months*1
  • 11.8% increase at 18 months*1

1Data on file, Lilly Research Laboratories (FOR20090922A). ROBERT MARCUS, OUHONG WANG, JULIE SATTERWHITE, and BRUCE MITLAK. The Skeletal Response to Teriparatide Is Largely Independent of Age,Initial Bone Mineral Density, and Prevalent Vertebral Fractures in Postmenopausal Women With Osteoporosis. JOURNAL OF BONE AND MINERAL RESEARCH. Volume 18, Number 1, 2003. � 2003 American Society for Bone and Mineral Research

In postmenopausal women with osteoporosis at high risk for fracture

FORTEO Reduced Vertebral Fracture Risk in a Median of 19 Months

Reduce fracture risk in your postmenopausal patients in 19 months with FORTEO.1

Graph A

Forteo

n=448 (placebo); with >=1 new vertebral fractures: 64. n=444 (FORTEO); with >=1 new vertebral fractures: 22.
(RR 0.35, 95% Cl, 0.22–0.55)
(AR: placebo 14.3%; FORTEO 5.0%; P<0.001)
*Fracture Prevention Trial: 1,637 postmenopausal women 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.

Graph B

Forteo

n=448 (placebo); with >=2 new vertebral fractures: 22. n=444 (FORTEO); with >=2 new vertebral fractures: 5.
(AR: placebo 4.9%; FORTEO 1.1%)
The data presented are derived from patients who suffered either 2 or >=3 new fractures in the FORTEO group versus placebo group.



FORTEO Reduced Nonvertebral Fracture Risk in a Median of 19 Months.

Graph C

Forteo

n=544 (placebo); with >=1 new nonvertebral fractures: 30.
n=541 (FORTEO); with >=1 new nonvertebral fractures: 14.
(RR 0.47, 95% Cl, 0.25–0.88)
(AR: placebo 5.5%; FORTEO 2.6%, P<0.05)
Fragility fractures were defined as fractures occurring with minimal trauma (eg, falling from standing height).

Non vertebral fracture risk reduction data achieved by pooling data from the following sites:

  • Ankle
  • Foot
  • Ribs
  • Hip
  • Wrist
  • Humerus
  • Other sites
  • Pelvis

1N Engl J Med. 2001;344:1434-1441.
2FORTEO Prescribing Information. PA005FSHK02.

In Patients With Sustained Systemic Glucocorticoid-Induced Osteoporosis at High Risk for Fracture

For patients with osteoporosis associated with sustained, systemic glucocorticoid therapy at high risk for fracture, FORTEO significantly increases BMD.*1

Forteo

*Because of differences in mechanism of action (anabolic vs antiresorptive) and lack of clarity regarding differences in BMD as an adequate predictor of fracture efficacy, data on the active comparator are not presented.

The efficacy of FORTEO for treating glucocorticoid-induced osteoporosis was assessed in a randomized, double-blind, active-controlled trial of 428 men and women treated with a >=5 mg/day prednisone or equivalent for a minimum of 3 months. The duration of the trial was 18 months with 214 patients exposed to FORTEO. In the FORTEO group, the mean (+/- SD) baseline lumbar spine BMD was 0.85 +/- 0.13 g/cm2 and lumbar spine BMD T-score was –2.5 +/- 1. All patients received 1,000 mg of calcium plus 800 IU of vitamin D supplementation per day.


1N Engl J Med. 2007;357:2028-2039
2Statistically significant from baseline, P<0.001.

Forteo

  • Significant increases were also seen with FORTEO at the femoral neck (P=0.029)1

*FORTEO use in Male Patients Phase 3 Trial: 437 men with primary or hypogonadal osteoporosis were evaluated. Mean age: 59. Median duration of exposure to therapy: 10 months (maximum 14 months). All received 1,000 mg/day of calcium and 400–1,200 IU/day of vitamin D.

P<0.001 for FORTEO compared with placebo at each postbaseline time point.


1J Bone Miner Res. 2003;18:9-17.


Last Update: 15 Nov 2016

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