Use of NPSP558 in the Treatment of Hypoparathyroidism

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoparathyroidism

In brief

Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.

Key facts

Study ID

NCT00732615

Run by

Shire

People needed

124

Starts

2008-12-18

Expected to finish

2011-09-28

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet all of the following inclusion criteria can be enrolled and potentially randomized into this study:
• Adult males or females 18 to 85 years of age (prior to screening)
• History of hypoparathyroidism for ≥ 18 months
• Requirement for vitamin D metabolite/analog therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day prior to randomization. Requirement for supplemental oral calcium treatment ≥ 1000 mg per day over and above normal dietary calcium intake
• Serum thyroid function tests within normal laboratory limits at screening
• Serum magnesium levels within laboratory normal limits
• Serum 25-hydroxyvitamin D [25(OH)D] level ≤ 1.5-fold the laboratory upper limit of normal
• Creatinine clearance > 30 mL/min on two separate measurements OR creatinine clearance > 60 mL/min AND serum creatinine < 1.5 mg/dL
• With regard to female patients: women who are postmenopausal and women who are surgically sterilized can be enrolled. Women of childbearing potential must have a negative pregnancy test at Randomization and be willing to use two medically acceptable methods of contraception for the duration of the study.

You may not qualify if…

• Patients who have any of the following during the screening visit are not eligible for enrollment in this study:
• Known history of hypoparathyroidism resulting from an activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism)
• Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease, insulin dependent diabetes mellitus (IDDM) or poorly controlled Type II diabetes mellitus (HbA1C > 8%), severe and chronic cardiac, liver or renal disease, Cushing's syndrome, neuromuscular disease such as rheumatoid arthritis, myeloma, pancreatitis, malnutrition, rickets, recent prolonged immobility, active malignancy, primary or secondary hyperparathyroidism, a history of parathyroid carcinoma, hypopituitarism, acromegaly, or multiple endocrine neoplasia types I and II
• Patients with a history of thyroid cancer must be documented to be disease-free for a period of at least 5 years
• Patients dependent on regular parenteral calcium infusions (eg calcium gluconate) to maintain calcium homeostasis
• Patients that have undergone gastric resection or have active peptic ulcer disease requiring medical therapy
• Use of prohibited medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, estrogens and progestins for hormone replacement therapy,methotrexate, or systemic corticosteroids within respective prohibited periods
• Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34) or other N-terminal fragments or analogs of PTH or PTH-related protein within 6 months prior to screening
• Other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets, or cinacalcet hydrochloride within the prohibited period
• Use of oral bisphosphonates within the previous 6 months or IV bisphosphonate preparations within the previous 12 months prior to screening
• Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening
• Presence of open epiphyses
• Irradiation (radiotherapy) to the skeleton within 5 years
• Serum 25-hydroxyvitamin D levels greater than 1.5-fold the laboratory upper limit of normal
• Participation in any other investigational trial in which receipt of investigational drug or device occurred within 6 months prior to screening for this study
• Pregnant or lactating women
• History of diagnosed drug or alcohol dependence within the previous 3 years
• Clinical history of renal calculi within the past 12 months
• History of gout
• Disease processes that may adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease
• Chronic/severe cardiac disease including but not limited to cardiac insufficiency, arrhythmias, bradycardia (resting heart rate < 60 beats/minute), or hypotension (systolic and diastolic blood pressures < 100 and 60 mmHg, respectively)
• History of cerebrovascular accident (CVA).

Where it is running

• Mayo Clinic-Scottsdale — Scottsdale, Arizona, United States
• Advance Medical Research LLC — Lakewood, California, United States
• Diabetes Associates — Orange, California, United States
• University of California-San Francisco VA Medical Center — San Francisco, California, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Michigan Bone and Mineral Clinic PC — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• University Physicians Group — Staten Island, New York, United States
• Physicians East — Greenville, North Carolina, United States
• University of Cincinnati Bone Health and Osteoporosis Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cetero Research DGD Research Inc. — San Antonio, Texas, United States
• Hillcrest Family Health Center — Waco, Texas, United States
• The Vancouver Clinic — Vancouver, Washington, United States
• Chetre Hospitalier Universitaire de Liege — Liège, Belgium
• Heritage Medical Research Clinic — Calgary, Alberta, Canada
• Capital District Health Authority, QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• Oakville Bone Center — Oakville, Ontario, Canada
• Aarhus University Hospital — Aarhus, Denmark
• Odense University Hospital — Odense, Denmark

Full record on ClinicalTrials.gov

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