Last updated on October 2018

Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Hypoparathyroidism | Hypoparathyroidism
  • Age: Between 18 - 85 Years
  • Gender: Male or Female
  • Other:
    Subjects that are currently or previously enrolled in the core study (AAAE0544) and
    have maintained uninterrupted therapy with rhPTH(1-84) (transient interruptions of up
    to 1 month continuously off treatment may be allowed).
    Signed and dated informed consent form (ICF).
    Adult men and women 18 to 85 years of age.
    History of hypoparathyroidism for at least 12 months prior to rhPTH(1-84) treatment,
    defined by the requirement for supplemental calcium and/or active vitamin D to
    maintain serum calcium along with an undetectable or insufficient Parathyroid hormone
    (PTH) concentration.
    Able to perform daily subcutaneous self-injections of study medication (or have
    designee perform injection).
    Willingness and ability to understand and comply with the protocol. Women must agree
    to pregnancy testing and acceptable methods of contraception, as detailed in the
    protocol.

You may not be eligible for this study if the following are true:

  • The subject is treated or has been treated with any investigational drug, aside from
    rhPTH(1-84), within 30 days of consent.
    As assessed by the investigator, the subject has a safety or medical issue that
    contraindicates participation in the study.
    The subject and/or the subject's parent(s) or legally-authorized representative(s) is
    unable to understand the nature, scope, and possible consequences of the study.
    The subject is unable to comply with the protocol, eg, uncooperative with protocol
    chedule, refusal to agree to all of the study procedures, inability to return for
    evaluations, or is otherwise unlikely to complete the study, as determined by the
    investigator or the medical monitor.
    The subject is pregnant or lactating.
    Subjects who are at increased baseline risk for osteosarcoma such as subjects with
    Paget's disease of bone or unexplained elevations of alkaline phosphatase, subjects
    with hereditary disorders predisposing to osteosarcoma or subjects with a prior
    history of external beam or implant radiation therapy involving the skeleton.

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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