Synonym |
Teriparatide Acetate |
Species |
Human |
Protein Accession |
P04177 |
Purity |
Greater than 95% |
Endotoxin Level |
Less than 0.1 EU per μg of the protein |
Biological Activity |
The activity was measured by its ability to bind with immobilized PTH1R in a functional ELISA.
|
Expression System |
E. coli |
Fusion Tag |
None |
Predicted Molecular Mass |
4224 Da |
Formulation |
Lyophilized from a 0.2 μm filtered solution of PBS, pH 7.4 |
Reconstitution |
Reconstitute in water to a concentration of 0.1-1.0 mg/ml |
Storage & Stability |
Store lyophilized protein at -20°C to -70°C. Store reconstituted protein at 2-8°C for one week
or in aliquots at -20°C to -70°C for long-term storage. |
FAQ
What is Teriparatide Acetate, and how does it work in the body?\n\nTeriparatide Acetate is a synthetic
form of parathyroid hormone used in the treatment of certain types of osteoporosis. Osteoporosis is a
condition characterized by weakened bones, which increases the risk of fractures. It primarily affects
postmenopausal women, men with hormonal imbalances, and individuals on glucocorticoid therapy.
Teriparatide Acetate works by mimicking the activity of the natural human parathyroid hormone. This
hormone plays a critical role in calcium and phosphate metabolism in bones and kidneys. In healthy
physiology, parathyroid hormone regulates calcium levels in the blood, influences the absorption and
utilization of calcium, and affects bone remodeling. When administered as a medication, Teriparatide
Acetate stimulates osteoblasts—cells responsible for new bone formation. It promotes bone growth by
encouraging the laying down of bone matrix and enhancing the absorption of calcium. Unlike many other
osteoporosis treatments that primarily inhibit bone resorption (the breakdown of bone by cells called
osteoclasts), Teriparatide Acetate's ability to promote new bone growth makes it unique. This dual
action results in an increase in bone mineral density (BMD), which is a crucial factor in reducing the
risk of fractures. By increasing bone strength and density, Teriparatide Acetate effectively reduces the
likelihood of fractures, particularly in the spine and hip areas which are often the most susceptible in
osteoporotic patients. In some clinical studies, patients who took Teriparatide Acetate were seen to
have up to a 65% decrease in vertebral fractures and a nearly 53% decrease in non-vertebral fractures.
This significant reduction highlights the drug's effectiveness and its potential to improve the quality
of life in individuals with severe osteoporosis. It is important to note, however, that Teriparatide
Acetate is typically prescribed for individuals at high risk for fractures and is generally recommended
for use over a limited duration, often up to two years, as extended use carries potential risks that
need to be thoroughly assessed by healthcare providers.\n\nWho can benefit the most from using
Teriparatide Acetate?\n\nTeriparatide Acetate is principally beneficial for individuals who have been
diagnosed with osteoporosis and are at a high risk of fractures. This medication is particularly useful
for postmenopausal women, as they are among the largest demographic with increased osteoporosis risk due
to the significant drop in estrogen levels after menopause. Estrogen is a hormone that helps to maintain
bone density, and its reduction accelerates bone loss, making women more susceptible to osteoporosis.
Similarly, men suffering from osteoporosis due to primary or hypogonadal osteoporosis—conditions
characterized by low bone density linked to hormonal imbalances—can also benefit significantly from
systemic treatment with Teriparatide Acetate. Another group who may gain from this medication are
individuals with osteoporosis induced by long-term glucocorticoid therapy. Glucocorticoids, or steroid
drugs, are often prescribed to reduce inflammation in chronic illnesses such as rheumatoid arthritis or
asthma. However, their prolonged use can lead to decreased bone mass and an increase in fracture risk.
Teriparatide Acetate can play a vital role in counteracting this side effect by promoting new bone
formation and improving bone strength. Those who have not responded well to other osteoporosis
treatments or are unable to take other medications due to contraindications can also consider
Teriparatide Acetate a viable option. Furthermore, patients who have already experienced osteoporotic
fractures can significantly benefit from Teriparatide Acetate to prevent further fractures and
deteriorations in bone health. The drug's ability to both build new bone and improve bone architecture
makes it particularly well-suited to individuals with severe, established osteoporosis where the risk of
breaking bones is exceedingly high. This dual-action is crucial where the enhancement of bone strength
is needed swiftly to prevent further injury. For patients who have already sustained fractures, this
drug offers a chance to rebuild bone density and mitigate further risks. However, it's crucial for
potential candidates to consult their healthcare provider to discuss their specific condition, risk
factors, and the suitability of Teriparatide Acetate as part of their osteoporosis management
plan.\n\nAre there any side effects associated with taking Teriparatide Acetate?\n\nLike any medication,
Teriparatide Acetate is associated with potential side effects, though not everyone will experience
them. It’s crucial for patients and healthcare providers to weigh the benefits of treatment against any
potential risks. The most common side effects observed with Teriparatide Acetate use include nausea, leg
cramps, dizziness, and injection site reactions such as pain, redness, bruising, or swelling. These side
effects are generally mild and may resolve as the body adjusts to the medication. However, some users
might experience more systemic effects such as headache, increased sweating, or a feeling of weakness or
fatigue. A more concerning but rare side effect is the potential for causing excessively high levels of
calcium in the blood, a condition known as hypercalcemia. Symptoms of hypercalcemia may include
confusion, muscle weakness, or abdominal pain. If any of these occur, the patient should seek medical
consultation promptly, as adjustments to their treatment might be necessary. Teriparatide Acetate has
also been associated with orthostatic hypotension—the sudden drop in blood pressure when standing up
from sitting or lying down—which can lead to dizziness or lightheadedness. It is advisable for patients
to rise slowly from sitting or lying positions to minimize this risk. In animal studies, particularly
studies involving rats, there has been a noted incidence of an increase in bone tumors, specifically
osteosarcoma, with long-term use of Teriparatide Acetate. While these results have not been directly
observed in humans, it is a significant consideration for healthcare providers when prescribing the
medication, and it is why the drug is generally not used for more than two years consecutively. Patients
with certain pre-existing conditions like Paget’s disease, unexplained elevations of alkaline
phosphatase, or a history of bone cancer or radiation therapy involving bones should not use
Teriparatide Acetate. Understanding these side effects is critical, and it is important that individuals
taking the medication communicate any new or persistent symptoms to their healthcare provider for
appropriate management, ensuring the ongoing suitability of the treatment.\n\nHow long should a patient
use Teriparatide Acetate?\n\nThe duration of treatment with Teriparatide Acetate is generally capped at
a maximum of two years over a patient's lifetime. This limitation is guided by both the results of
clinical efficacy trials and safety concerns drawn from extended biological studies. Unlike other
osteoporosis treatments that might be taken indefinitely, Teriparatide Acetate builds new bone
significantly over a relatively short period. Most of the benefits of Teriparatide Acetate in increasing
bone mineral density and reducing fracture risk are accrued during this two-year period. After two
years, alternative osteoporosis treatments, such as bisphosphonates, are often considered to help
maintain the gains achieved with Teriparatide Acetate. These subsequent treatments can continue the
prevention of bone resorption, thereby maintaining the density improvements gained from the bone-forming
phase offered by Teriparatide Acetate. Importantly, the finite duration of use is also influenced by
safety considerations. In preclinical studies, particularly those using rodent models, longer durations
of high-dose Teriparatide Acetate raised concerns regarding the risk of developing osteosarcoma, a type
of bone cancer. Although this has never been proven in humans, healthcare providers monitor these
possibilities closely and continually weigh the benefits against potential risks. Thus, to mitigate any
potential long-term risks, the two-year limit is generally adhered to. It's crucial for patients to
maintain regular follow-ups with their healthcare provider to reassess bone health, evaluate treatment
efficacy, and decide on the best subsequent therapy post-Teriparatide Acetate treatment. Every
Osteoporosis management plan is personalized, factoring in the patient's bone density response, overall
health, and risk factors throughout the course of treatment. For some patients, the therapeutic strategy
may shift to other osteoporosis medications, lifestyle changes, dietary adjustments, or a combination of
these to ensure optimal management of bone health. Additionally, during and after treatment with
Teriparatide Acetate, patients are often recommended to maintain an adequate intake of calcium and
vitamin D in their diets to support overall skeletal health and maximize the treatment benefits.\n\nWhat
precautions should patients take while using Teriparatide Acetate?\n\nPatients prescribed Teriparatide
Acetate should adhere to several precautions to ensure safety and maximize the treatment’s efficacy.
Firstly, it’s essential to follow dosing instructions carefully, typically involving subcutaneous
injections once daily into the thigh or abdominal area. Proper administration technique helps to avoid
complications and ensures that the medication is absorbed correctly. Prior to beginning treatment,
patients should inform their healthcare provider of their full medical history, particularly any bone
disorders other than osteoporosis, such as Paget’s disease, a history of bone cancers, or metabolic bone
conditions such as renal osteodystrophy. These conditions could potentially contraindicate Teriparatide
Acetate use. Owing to the potential risk of hypercalcemia, patients should regularly monitor their blood
calcium levels, especially if they experience symptoms such as confusion, nausea, vomiting, or frequent
urination, which might indicate elevated calcium levels. During treatment, maintaining hydration is
important, as it can help mitigate potential side effects such as dizziness or hypotension when changing
positions. This is particularly relevant because Teriparatide Acetate can, in some patients, cause a
drop in blood pressure. Patients should rise slowly from sitting or lying positions to prevent dizziness
or falls. Although there is no specific diet required while on Teriparatide Acetate, maintaining a diet
sufficient in calcium and Vitamin D is advisable, as these nutrients are essential for bone health and
will complement the action of the medication. Any supplements should, however, be taken under the advice
of a healthcare provider to avoid excessive intake. Given that Teriparatide Acetate is associated with
potential tumor risks seen in animal studies and theoretical risks in humans, ongoing monitoring by
healthcare professionals is critical. Patients should have regular consultations to evaluate their
response to treatment, bone density improvements, and adjust therapy as necessary. Finally, an important
precaution involves ensuring that injection sites are rotated daily to prevent local irritation and help
distribute the drug's absorption consistently. Properly disposing of needles and syringes is also
crucial for safety and hygiene, and patients should use a sharps container for disposal. Adherence to
these precautions can help ensure that the benefits of Teriparatide Acetate are realized while
minimizing any potential risks or side effects associated with treatment.\n\nCan Teriparatide Acetate be
used in conjunction with other osteoporosis treatments?\n\nTeriparatide Acetate can be a part of a
comprehensive osteoporosis treatment regimen, but its simultaneous use with other osteoporosis
medications requires careful consideration and professional medical supervision. There is a variety of
classes of drugs used to manage osteoporosis, including bisphosphonates, denosumab, selective estrogen
receptor modulators (SERMs), and hormone replacement therapies among others, each with its own
mechanisms of action aimed primarily at reducing bone resorption or promoting bone formation.
Teriparatide Acetate stands out as one of the few treatments that actively promote bone formation.
However, concurrent use of Teriparatide Acetate with antiresorptive agents (those that reduce bone
turnover, like bisphosphonates) is not usually recommended. This is because the primary mechanism of
action of antiresorptive agents is to slow down bone degradation, which might counteract or alter the
bone formation efficacy stimulated by Teriparatide Acetate. Clinical studies have yet to demonstrate a
clear advantage in combining these therapies, and it could potentially lead to adverse effects or
mitigate the desired bone-building properties of Teriparatide Acetate. That said, Teriparatide Acetate
is often sequenced with other osteoporosis treatments to maintain bone density gains. After completing a
cycle of Teriparatide Acetate (generally two years), transitioning to antiresorptive therapies like
bisphosphonates is common practice to sustain the bone mass improvements achieved during Teriparatide
Acetate therapy. This strategy can be particularly important for maximizing long-term bone health
benefits and minimizing fracture risks after the patient’s bone density has been built with Teriparatide
Acetate. In certain specific cases, Teriparatide Acetate might be prescribed along with calcium and
vitamin D supplements to ensure adequacy and enhance bone health, but, again, these should be managed
under healthcare supervision to avoid complications such as hypercalcemia. It's essential for patients
and healthcare providers to customize osteoporosis management plans based on the individual’s health
status, response to medication, and specific risk factors. Decision-making regarding the combination or
sequential use of osteoporosis treatments should always be driven by careful clinical assessment and the
ongoing monitoring of bone health markers. Always consulting with a healthcare provider will ensure the
most effective and safe use of Teriparatide Acetate as part of an osteoporosis treatment plan.\n\nIs
Teriparatide Acetate safe for long-term use?\n\nTeriparatide Acetate is generally not recommended for
long-term use due to safety and efficacy considerations that have been determined through extensive
clinical and preclinical studies. The standard duration of treatment with Teriparatide Acetate is capped
at two years over a patient’s lifetime. The two-year treatment duration is not only due to significant
gains in bone mineral density and fracture risk reduction during that period, but also due to safety
concerns that have emerged from long-term studies. Prolonged use beyond two years has not been
extensively studied in humans, raising questions about the safety and potential risks that might occur
with extended therapy. The major concern regarding long-term use of Teriparatide Acetate comes from
preclinical animal studies, where rats subjected to high doses over extended periods developed
osteosarcoma, a type of bone cancer. While these findings have not been observed in humans receiving
therapeutic doses, such outcomes have informed guidelines and precautions in clinical practice to limit
usage duration. Healthcare providers adhere to these guidelines to mitigate any theoretical risks while
optimizing patient outcomes. After completing the two-year course of Teriparatide Acetate, patients
often transition to other osteoporosis treatments that maintain bone density, such as bisphosphonates.
This complementary approach allows for continued management of osteoporosis and helps to preserve the
bone health gains achieved with Teriparatide Acetate. While research and clinical debate continue, the
consensus currently remains that the two-year limit provides a balance between maximizing therapeutic
benefits and minimizing potential risks. Additionally, within this two-year period, rigorous monitoring
and assessment are crucial to ensure that the treatment is both effective and safe. Regular follow-up
appointments with healthcare providers, comprehensive assessments of bone density, and the evaluation of
any emerging symptoms are essential components of responsible Teriparatide Acetate treatment. Patients
should always consult with their healthcare providers for personalized medical advice and to discuss any
concerns about treatment duration, benefits, and potential risks. This collaborative approach ensures a
tailored and effective strategy for managing osteoporosis in the safest way possible.\n