Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Subjects With Hypoparathyroidism

Overview

About this study

This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara®).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. History of hypoparathyroidism
  2. Requirement for supplemental oral calcium treatment ≥ 1000 mg per day.
  3. Requirement for active vitamin D therapy at a dose of ≥ 0.25 mcg per day . (i.e., ≥ 0.25 mcg calcitriol or equivalent per day).
  4. Serum calcium levels within the laboratory normal range based on clinical chemistry lab results at Screening (central and/or local lab) and Treatment Period 1, Day -2 (central and/or local lab) or, if outside the normal range, considered as not significant by the Investigator.
  5. Urinary calcium excretion ≥200 mg (5mmol)/24h, based on a 24-hour collection prior to check-in to the CRC at Treatment Period 1, Day -2 (central and/or local lab).
  6. Serum magnesium level within the laboratory normal range at the screening examination or, if outside the normal range, considered as not significant by the Investigator.
  7. Serum thyroid function tests within normal laboratory limits at screening, or if outside of the normal range, considered as not clinically significant by the Investigator.
  8. Serum 25(OH) D level between the lower limit of normal and 1.5 fold the laboratory upper limit of normal at the first screening visit or, if outside the normal range, considered as not significant by the Investigator.
  9. Serum creatinine < 1.5 mg/dL (<133 micromol/L) AND creatinine clearance > 60 mL/ minute(>1.002mL/s).

Exclusion Criteria:

  1. Participation in any other investigational drug study within the last 3 months
  2. Use of any of the following prior to study drug administration:
    1. 14 days: thiazide diuretics
    2. 30 days: loop diuretics, lithium, , systemic corticosteroid
    3. 3 months: calcitonin, cinacalcet hydrochloride, rhPTH(1-84) or N-terminal PTH or PTH-related peptide fragments or analogs
    4. Females only; changes in hormone replacement therapy within 3 months
    5. 6 months: fluoride tablets, oral bisphosphonates, methotrexate growth hormone, digoxin; raloxifene or similar selective estrogen receptor modulators
    6. 12 months: intravenous bisphosphonates, drug or alcohol abuse
  3. History of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine (with exception of the condition under study), or neurologic system(s) or psychiatric disease as determined by the Investigator.
  4. Known history of hypoparathyroidism resulting from an activating mutation in the calcium sensing receptor (CaSR) gene or impaired responsiveness to PTH (pseudohypoparathyroidism).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Bart Clarke, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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