TransCon PTH for Endocrine System Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ascendis Pharma Investigational Site, Rochester, MN
Endocrine System Diseases+2 More
TransCon PTH - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called TransCon PTH can help people with osteoporosis.

See full description

Eligible Conditions

  • Endocrine System Diseases
  • Hypoparathyroidism
  • Parathyroid Diseases

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TransCon PTH will improve 1 primary outcome and 1 secondary outcome in patients with Endocrine System Diseases. Measurement will happen over the course of 4 weeks of treatment.

4 weeks
Efficacy - Primary endpoint
4 weeks of treatment
Efficacy - Key Secondary Endpoint

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

TransCon PTH 15 mcg
1 of 4
TransCon PTH 18 mcg
1 of 4
TransCon PTH 21 mcg
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 40 total participants across 4 different treatment groups

This trial involves 4 different treatments. TransCon PTH is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

TransCon PTH 15 mcg
CombinationProduct
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH 18 mcg
CombinationProduct
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH 21 mcg
CombinationProduct
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
Placebo
CombinationProduct
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks for reporting.

Closest Location

Ascendis Pharma Investigational Site - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
with or without calcium supplements Patients who receive ≥0.25 μg BID of calcitriol (active vitamin D) or ≥0.5 μg BID or ≥1.0 μg daily of alfacalcidol (active vitamin D) are more likely to achieve a target serum 25-hydroxyvitamin D level of ≥30 ng/mL than those who receive less. show original
Take calcium citrate or carbonate two times a day, at least 400 mg each time. show original
The text states that the patient's eGFR was more than 30 mL/min/1.73m2 during screening. show original
People aged ≥18 years old, both male and female. show original
People who have had surgery and have chronic HP or a autoimmune, genetic, or idiopathic HP condition for at least 26 weeks. show original
25(OH) vitamin D levels of 30-70 ng/mL (75-175 pmol/mL)
Magnesium level within the normal range
A serum calcium level that is lower than normal, but not low enough to be considered a medical emergency. show original
The person's BMI was 17-40 kg/m2 at their first visit. show original
If you are ≤25 years of age, based on an x-ray of your non-dominant wrist and hand, there is evidence of epiphyseal closure. show original

Patient Q&A Section

What causes hypoparathyroidism?

"The cause of hypoparathyroidism can vary widely, even between familial and sporadic disease. The common causes of hypoparathyroidism are: amyloidosis, thyroid disease, and tumor. While the role of amyloidosis in hypoparathyroidism is not fully understood, patients with amyloidosis, like many patients with Sjögren syndrome and/or other diseases, often have low calcium and parathyroid hormone levels. Patients with hypoparathyroidism and low levels of PTH are more likely to have autoimmune disease than hypoparathyroid patients who do not have symptoms of disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypoparathyroidism?

"Treatment choices differ according to the age of the patient. Although both surgery and radiation have been historically used, radiation is more common in children and is the primary treatment in infants and newborns. Surgery is commonly used in adults, although it is more common in children over the age of 10. A variety of different surgical techniques exist, but the most common in children, including total parathyroidectomy with autograft and cervical thymectomy. Despite the advances made in radioiodine technology, it is often performed only as a last resort when all surgical options have been exhausted." - Anonymous Online Contributor

Unverified Answer

Can hypoparathyroidism be cured?

"Results from a recent clinical trial suggest a small benefit in treating hypocalcemia (as of decreasing bone resorption and increasing bone formation) by administering active vitamin D and vitamin D analogues in the setting of chronic hypocalcemia caused by primary and secondary hyperparathyroidism." - Anonymous Online Contributor

Unverified Answer

What is hypoparathyroidism?

"Hypoparathyroidism is a rare disease. Physicians working in the field of endocrinology and sub-specialty care of all ages and specialties need to understand and treat this condition. This information on hypoparathyroidism is vital and has a wide range of uses. There are no guidelines that apply to all cases or in any age group. This information allows physicians to take into account the differential diagnosis of other endocrine conditions. It allows the patients and family members to understand where the most pressing medical issue is. This information can be used by a patient's primary care provider at the time of diagnosis." - Anonymous Online Contributor

Unverified Answer

How many people get hypoparathyroidism a year in the United States?

"Findings from a recent study of this study suggest that the mean incidence of hypoparathyroidism is one case of this disorder per 1,000 elderly adults per year in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypoparathyroidism?

"Symptoms of hypoparathyroidism may include tiredness, loss of appetite and weight loss. Parathyroid hormone levels are usually normal, but may be raised in those affected, particularly in those with a lower number of parathyroid glands. This raises the possibility of subclinical hypoparathyroidism.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving transcon pth?

"Despite the high success rate of transcutaneous pth implants, no further trials were reported in the literature. It is necessary to carry out more such trials to explore the effect of pth on bone remodeling before recommending this method in clinical practice." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hypoparathyroidism?

"Many subjects with hypoparathyroidism are unaware that clinical trials exist, which limits dissemination and acceptance of therapy. A minority of patients with severe disease will be enrolled in clinical trials, suggesting that clinical trials may be underused." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of transcon pth?

"Patients and their health care providers may not know how much they are exposed to medication at home or work. This exposure to medication has been linked to the risk of numerous medical problems. Please ask your doctor or pharmacist to show you your drug labels. The label might contain information about how much you are exposed to medication. In addition, please ask your doctor or pharmacist to tell you the risks that you may be exposed to, because many risks are only risks if they are great enough for the benefits to be not worth the risks. If you would like to find out more about medication, take the time to consult your health care provider." - Anonymous Online Contributor

Unverified Answer

How serious can hypoparathyroidism be?

"Serious hypoparathyroidism is frequently unrecognized. This disorder often causes the nonspecific symptoms of anemia, fatigue, and malaise. These symptoms can lead physicians to underestimate the true severity of hypoparathyroidism." - Anonymous Online Contributor

Unverified Answer

What is transcon pth?

"In patients presenting with hypoparathyroidism owing to transposition, thyroid surgery should be prioritized, as it is the only method that can lead to a normal or increased hormone secretion." - Anonymous Online Contributor

Unverified Answer

Does transcon pth improve quality of life for those with hypoparathyroidism?

"Overall, our study found quality of life to improve regardless of severity of hypoparathyroidism after the transcon pth implant for 12 months in patients with symptomatic hypoparathyroidism." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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