The treatment protocol has been previously reported.3 (link) Subjects received teriparatide 20 μg/day (Forteo [a registered trade name of Eli Lilly and Company], Indianapolis, IN, USA), or placebo, administered subcutaneously, for a maximum of 24 months. All subjects received 610 mg calcium and 400 IU vitamin D supplementation daily (a dosage chosen to meet dietary reference values recommended by the Japanese health authorities) from the start of the screening phase and throughout the study. Male subjects were randomized at a 2:1 ratio to receive teriparatide or placebo, while female subjects were stratified based on BMD at the lumbar spine <65%, 65%–70%, or 70%–80% of YAM, and were then randomized at a 2:1 ratio using dynamic allocation within each stratum. Upon completing the 12-month double-blind treatment period, all subjects received teriparatide during a 12-month open-label treatment period. Thus, responses in the teriparatide 20 μg/day and placebo groups were compared through 12 months. In addition, the response through 24 months of teriparatide 20 μg/day dosing was assessed for subjects randomized to teriparatide who continued in the open-label period, as well as for subjects originally randomized to placebo who entered the open-label teriparatide treatment period (placebo-teriparatide group).3 (link)
Forteo
Manufactured by Eli Lilly
Sourced in United States
Forteo is a laboratory instrument designed for the administration of teriparatide, a synthetic form of the parathyroid hormone. It is used to measure and deliver precise doses of teriparatide for therapeutic purposes.
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Lab products found in correlation
10 protocols using forteo
1
Teriparatide Treatment for Osteoporosis
2
Synthesis and Characterization of Abaloparatide and Teriparatide
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Abaloparatide and teriparatide were chemically synthesized (LifeTein, NJ) and purified by reverse‐phase chromatography (>95% pure). The molecular mass of the peptide was verified by mass spectrometry, and the net peptide content and composition were confirmed by amino acid analysis. It is not possible to use the commercially available teriparatide (Forteo, Lilly) and abaloparatide (Tymlos, Radius) in animals due to the low concentration formulation for human use and the prohibitively high cost of the commercial products for human use. Tissue culture media were purchased from GE Healthcare Life Sciences HyClone Laboratories (Logan, Utah). Fetal bovine serum (FBS) (Cat number 900–108, lot number A47D) was from Geminibio‐Products (West Sacramento, CA). Penicillin‐streptomycin (PS, Cat number MT‐30‐001‐CI), Trypsin (0.05%, Cat number 25‐300‐054), and phosphate‐buffered saline (PBS, Cat number 10‐010‐072) were from Lifescience Technologies (Grand Island, NY). 3‐isobutyl‐1‐methylxanthine (IBMX) (Cat number I5879) was from Sigma‐Aldrich (St. Louis, MO). Tissue culture plates and other supplies were from Corning (Oneonta, NY) and Fisher Scientific (Pittsburgh, PA).
3
Osteoporosis and PTH Treatment in Rabbits
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Fifteen 17-week-old female New Zealand White rabbits (3.0-3.5 kg body weight) were used in this study. The experimental design is shown in Figure 1 . All animals initially underwent ovariectomy, and, 2 weeks later, they received intramuscular injections of methylprednisolone acetate (0.5 mg/kg/day) (Depo-Medrol®, Pfizer, New York, New York, USA) for 4 consecutive weeks to induce osteoporosis3 ,4 . Seven weeks after ovariectomy, the animals were divided into three groups. The first group received subcutaneous PTH (40 μg/day, 5 days/week) (Forteo®, Eli Lilly, Indianapolis, Indiana, USA) for 4 weeks (PTH1 group) until implant placement, then saline was administrated for 4 weeks. The second group received subcutaneous PTH for 4 weeks before and after implant placement (PTH2 group), and the third group received saline vehicle solution for 4 weeks before and after implant placement as osteoporosis (control group). The study end point was at 4 weeks after implant placement.
4
Comparative Phase 3 Trial of RGB-10 and Teriparatide
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A multicenter, randomized, active comparator-controlled, rater-blinded, parallel-group phase 3 study (JapicCTI-163208) was conducted at 34 sites in Japan. After a screening period of 2 weeks, patients were randomly assigned 1:1 to receive either RGB-10 (manufactured by Gedeon Richter Plc, Debrecen, Hungary) or reference teriparatide (Forteo®; Eli Lilly Japan K.K., Kobe, Japan) 20 μg once daily via subcutaneous self-injection for a treatment period of 52 weeks, followed by a follow-up period of 2 weeks. A multi-dose pen injector (ServoPen Fix®; Ypsomed AG, Burgdorf, Switzerland) was used for injection of RGB-10. This device has the same injection procedure as that of reference teriparatide and was confirmed to have a similar dose accuracy. All patients received daily oral supplementation of 610 mg calcium and 400 IU vitamin D as basal treatment throughout the screening and treatment period. Concomitant use of medication that can affect bone metabolism or cause secondary osteoporosis, such as bisphosphonates and systemic corticosteroids, was prohibited.
5
Teriparatide Treatment for 24 Months
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Patients were prescribed teriparatide 20 μg daily (Forteo®, Eli Lilly and Company, Indianapolis, IN, USA) by subcutaneous injection for a maximum of 24 months. Patients were followed for 24 months after index teriparatide prescription.
6
Teriparatide vs. Alendronate for MSC Mobilization
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Fifty-four patients were randomly divided into 2 groups receiving either teriparatide (Forteo®, Eli Lilly and Co., Indianapolis, IN, USA) or alendronate (Fosamax®, Merck & Co., Kenilworth, NJ, USA) therapy for 12 months (Table 1 ). The teriparatide group (n=28; age, 61.7±6.6 years) received teriparatide 20 μg once daily via a self-administered subcutaneous injection and the alendronate group (n=26; age, 62.8±7.3 years) received oral alendronate 70 mg tablet once weekly. In both groups, to minimize the risk of hypercalcemia or hypercalciuria, patients received daily supplements of calcium (1 g/day) and vitamin D (800 IU/day). Patients visited our clinic at 0, 1, 3, 6, and 12 months. After a rest of 20 minutes, whole-blood samples were collected from all participants, from a superficial brachial vein, with care to avoid stasis, hemolysis, and contamination by tissue fluids or exposure to glass. Flow cytometry analysis was performed to determine the number of circulating MSCs.
Six patients were randomly selected from the 28 women in the teriparatide group for collection of peripheral blood samples at baseline (control group) and 1 month (PTH group) for isolating circulating MSCs and evaluating their osteogenic differentiation potential.
Six patients were randomly selected from the 28 women in the teriparatide group for collection of peripheral blood samples at baseline (control group) and 1 month (PTH group) for isolating circulating MSCs and evaluating their osteogenic differentiation potential.
7
Intermittent vs Continuous PTH (1-34) Treatment
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The recombinant form of Human Parathyroid hormone N-terminus 1–34 amino acid; PTH (1–34) was purchased as Teriparatide (Forteo®) (Lilly, Indianapolis, IN, USA). PTH (1–34) treatment on hMSCs were divided into two groups: Intermittent (I) and Continuous (C). For intermittent treatment, hMSCs under OIM were treated with PTH (1–34) for two hours every day for seven days. After 2 h of treatments, the cells were washed and replaced with fresh OIM. For continuous treatment, hMSCs were treated with PTH (1–34) for two days in OIM for seven days. PTH (1–34) titration was initially performed using various concentrations (0.2, 1, 10, and 50 nM) to determine the optimum concentration to be used for subsequent assays. Phosphate-buffered saline (PBS) was used as vehicle-control group.
8
Genetic and Immunological Analysis of Hypoparathyroidism
9
Bone Regeneration with rhBMP-2 and PTH
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A total of 72 male Sprague–Dawley rats (8–10 weeks old; CLEA Japan, Inc., Tokyo, Japan) were divided into four groups. Group I (n = 12) included animals that were implanted with control carrier alone. Group II (n = 12) included animals that were implanted with carrier containing 1 μg of rhBMP-2. Group III (n = 12) included animals that were implanted with carrier alone, followed by injections of PTH 1-34 (Forteo; Eli Lilly and Company, Indianapolis, IN). Group IV (n = 12) included animals that were implanted with carrier containing 1 μg of rhBMP-2, followed by injections of PTH 1-34. Group V included animals that were implanted with carrier containing 10 μg of rhBMP-2. Group VI included animals that were implanted with carrier containing 10 μg rhBMP-2, followed by injections of PTH 1-34.
10
Teriparatide's Effect on Bone Metabolism
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This report presents a retrospective analysis of data from a previously published trial of the effect of treatment of postmenopausal women with teriparatide (Forteo, Eli Lilly, Indianapolis, IN, USA), a synthetic parathyroid hormone with bone anabolic properties, on bone metabolic flux at the hip [7 (link)]. Written informed consent was obtained from all participants and the study was approved by the St Thomas’ Hospital Research Ethics Committee (Reference number 09/H0802/117) and UK Administration of Radioactive Substances Advisory Committee. In brief, 30 treatment-naïve women with osteopenia (defined as a bone mineral density T-score at the spine or hip between −1 and −2.5) were randomised into two groups. One group received calcium and vitamin D (control group, n = 15) and the other group received 20 μg/day teriparatide (TPT) daily plus calcium and vitamin D for 12 weeks (TPT group, n = 15). Three subjects (2 from the TPT group and 1 from the control group) withdrew consent after randomisation and prior to treatment, so data from these subjects were excluded from the analysis.
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