BridgeMD
A study to test the effects and safety of palopegteriparatide in adolescents with long-term hypoparathyroidism
EU CTIS ID: 2025-523928-52-00
What this study is testing
To evaluate the efficacy of palopegteriparatide in adolescents with chronic hypoparathyroidism
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females, 12 to less than 18 years of age at the time of screening (defined as the date of signing informed consent).
- Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks. Diagnosis of hypoparathyroidism is established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels (Hypocalcemia is defined as a value below the reference range for normal at the performing laboratory. Inappropriately low serum PTH levels are defined as at or below the median value of the reference range for normal at the performing laboratory while the concomitant serum calcium is low. If specific lab results at the time of original diagnosis are not available, as historical diagnosis affirming these two components is adequate for inclusion).
- Prior to randomization, achieve normal levels of serum 25(OH) vitamin D and magnesium.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 prior to randomization utilizing the 2009 Schwartz equation: eGFR (mL/min/1.73m^2)= 36.5*((Height (cm))/(Serum Creatinine (µmol/L)))
- Body mass index (BMI) Z-score greater than -2 SDS and below + 3 SDS at Screening.
- Written, signed informed consent provided by parent(s) or legally acceptable representative(s) of the participant, and by the participant if in accordance to local health authority/ethics requirements. Assent from participant obtained in accordance with applicable regulatory requirements.
You likely can't join if
- Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia.
- Female participants who are pregnant, intend to become pregnant, or are lactating. Note: Acceptable, effective contraception is required for sexually active women of childbearing potential during the trial and for 2 weeks after the last dose of investigational product.
- Diagnosed drug or alcohol dependence within 3 years prior to Screening.
- Symptomatic or severe cardiac disease within 26 weeks prior to Screening including but not limited to congestive heart failure, symptomatic or severe valvular disease, myocardial infarction, severe or uncontrolled arrhythmias, bradycardia, symptomatic hypotension, abnormal systolic BP, or poorly controlled hypertension based on age and sex-specific reference ranges.
- Cerebrovascular accident within 5 years prior to Screening.
- Within 26 weeks prior to Screening: acute colic due to nephrolithiasis or acute gout. Note: Participants with asymptomatic renal stones are permitted.
See the full eligibility criteria
Who can join
- Males and females, 12 to less than 18 years of age at the time of screening (defined as the date of signing informed consent).
- Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks. Diagnosis of hypoparathyroidism is established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels (Hypocalcemia is defined as a value below the reference range for normal at the performing laboratory. Inappropriately low serum PTH levels are defined as at or below the median value of the reference range for normal at the performing laboratory while the concomitant serum calcium is low. If specific lab results at the time of original diagnosis are not available, as historical diagnosis affirming these two components is adequate for inclusion).
- Prior to randomization, achieve normal levels of serum 25(OH) vitamin D and magnesium.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 prior to randomization utilizing the 2009 Schwartz equation: eGFR (mL/min/1.73m^2)= 36.5*((Height (cm))/(Serum Creatinine (µmol/L)))
- Body mass index (BMI) Z-score greater than -2 SDS and below + 3 SDS at Screening.
- Written, signed informed consent provided by parent(s) or legally acceptable representative(s) of the participant, and by the participant if in accordance to local health authority/ethics requirements. Assent from participant obtained in accordance with applicable regulatory requirements.
- Written, signed informed consent provided by parent(s) or legally acceptable representative(s) of the participant, and by the participant if in accordance to local health authority/ethics requirements. Assent from participant obtained in accordance with applicable regulatory requirements.
What rules you out
- Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia.
- Female participants who are pregnant, intend to become pregnant, or are lactating. Note: Acceptable, effective contraception is required for sexually active women of childbearing potential during the trial and for 2 weeks after the last dose of investigational product.
- Diagnosed drug or alcohol dependence within 3 years prior to Screening.
- Symptomatic or severe cardiac disease within 26 weeks prior to Screening including but not limited to congestive heart failure, symptomatic or severe valvular disease, myocardial infarction, severe or uncontrolled arrhythmias, bradycardia, symptomatic hypotension, abnormal systolic BP, or poorly controlled hypertension based on age and sex-specific reference ranges.
- Cerebrovascular accident within 5 years prior to Screening.
- Within 26 weeks prior to Screening: acute colic due to nephrolithiasis or acute gout. Note: Participants with asymptomatic renal stones are permitted.
- Participation in any other interventional trial in which receipt of investigational product or device occurred within 8 weeks (or within 5.5 times the half-life of the investigational product) (whichever comes first) prior to Screening.
- Known allergy or sensitivity to PTH or any of the excipients [metacresol, mannitol, succinic acid, NaOH/(HCl)] of the investigational product.
- Any other reason that in the opinion of the investigator would prevent the participant from completing participation or following the trial schedule.
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than hypoparathyroidism, such as active hyperthyroidism; Paget disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C >9%, documented HbA1C result drawn within 12 weeks prior to Screening is acceptable); severe and chronic liver, or renal disease; Cushing syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; parathyroid carcinoma within 5 years prior to Screening; acromegaly; or multiple endocrine neoplasia types 1 and 2.
- Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy). Short course use of steroids (≤2 weeks/year) equivalent to prednisone ≤60 mg/day is permitted.
- Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1.
- Use of PTH-like drugs (whether commercially available or through participation in an investigational trial), including PTH(1-84), PTH(1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 4 weeks prior to Screening.
- Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets (>0.5 mg/day), strontium, or cinacalcet hydrochloride, within 12 weeks prior to Screening.
- Use of osteoporosis therapies known to influence calcium and bone metabolism, i.e., bisphosphonate (oral or intravenous [IV]), denosumab, raloxifene, or romosozumab therapies within 2 years prior to Screening.
- Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening.Note: History of seizures that occur in the setting of hypocalcemia is not exclusionary.
- Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.