A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
Condition: Chronic Hypoparathyroidism; Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: rhPTH(1-84)
Intervention description: Participants will receive 25, 50, 75, and 100 microgram (mcg) of rhPTH(1-84) subcutaneous injection to the thigh via a multidose pen injector device once daily for 36 months. The dose will be individualized based on Albumin-corrected Serum Calcium (ACSC) and 24-hour calcium urinary excretion to achieve a serum calcium level in the lower half of the normal range.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic
      administration of rhPTH(1-84) is a potential treatment option. The group of participants in
      the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism
      for up to 11 years. This study is designed to extend this experience and gain knowledge about
      how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a
      long-term duration.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants that are currently or previously enrolled in the core study (AAAE0544
             [NCT01199614]) and have maintained uninterrupted therapy with recombinant human
             parathyroid hormone (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 (SC) 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.

        Exclusion Criteria

          -  The participant 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 participant has any safety or medical issues that
             contraindicate participation in the study.

          -  The participant and/or the participant's parent(s) or legally-authorized
             representative(s) are unable to understand the nature, scope, and possible
             consequences of the study.

          -  The participant is unable to comply with the protocol, example, uncooperative with
             protocol schedule, 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 participant is pregnant or lactating.

          -  Participants who are at increased baseline risk for osteosarcoma such as participant
             with Paget's disease of bone or unexplained new elevations of alkaline phosphatase,
             participants with hereditary disorders predisposing to osteosarcoma or participants
             with a prior history of external beam or implant radiation therapy involving the
             skeleton.