Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: rhPTH(1-84)
Intervention description: Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is open to adults with hypoparathyroidism who complete the SHP634-101 study
      (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in
      adults with hypoparathyroidism who previously participated in the SHP634-101 study. All
      participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an
      injection.

      Patients who complete the SHP634-101 study will have the option to screen for this extension
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An understanding, ability, and willingness to fully comply with study procedures and
             restrictions

          -  Ability to voluntarily provide written, signed, and dated informed consent to
             participate in the study.

          -  Previously completed the SHP634-101 (NCT02781844) study, including the 30-day
             follow-up.

          -  Male or non-pregnant, non-lactating female subjects who agree to comply with
             applicable contraceptive requirements of the protocol or females of non-childbearing
             potential.

        Exclusion Criteria:

          -  Received investigational study drug, aside from that received in study SHP634-101
             (NCT02781844), within 3 months prior to the screening visit.

          -  Presence or 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, that in the opinion of the investigator, would make the subject unsuitable
             for this study.

          -  Received parathyroid hormone (PTH), PTH analog, or parathyroid hormone fragment 1-34
             [PTH(1-34)] treatment within the last 30 days from the screening visit.

          -  Subjects with a history of parathyroid hormone intolerance, based on investigator
             determination.

          -  Any disease that might affect calcium metabolism or calcium-phosphate homeostasis as
             determined by the investigator other than hypoparathyroidism, including but not
             limited to, active hyperthyroidism; poorly controlled insulin-dependent diabetes
             mellitus or type 2 diabetes mellitus; 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, bone metastases or a history of skeletal malignancies; primary or
             secondary hyperparathyroidism; a history of parathyroid carcinoma; hypopituitarism,
             acromegaly; or multiple endocrine neoplasia types 1 and 2 .

          -  Subjects who are at increased baseline risk for osteosarcoma such as subjects with
             Paget's disease of bone or unexplained elevations of alkaline phosphatase, young adult
             subjects with open epiphyses, subjects with hereditary disorders predisposing to
             osteosarcoma or subjects with a prior history of external beam or implant radiation
             therapy involving the skeleton.

          -  Use of the following medications prior to administration of investigational product
             within:

               1. 30 days-loop diuretics, lithium, systemic corticosteroids (medical judgment is
                  required by the investigator. Primarily high doses of systemic corticosteroids
                  [example (eg), prednisone] should be excluded. Stable doses of hydrocortisone
                  [eg, as treatment for Addison's disease] may be acceptable).

               2. 3 months-cinacalcet hydrochloride

               3. 6 months-fluoride tablets, oral bisphosphonates, methotrexate, growth hormone,
                  digoxin

               4. 12 months-intravenous bisphosphonates, drug or alcohol abuse, as determined by
                  the investigator

          -  Presence of any clinically significant results from laboratory tests, vital signs
             assessments, or electrocardiograms (ECG), that in the opinion of the investigator,
             would make the subject unsuitable for this study.

          -  Any medical condition or prior therapy that, in the opinion of the investigator, would
             make the subject unsuitable for this study.

          -  History of a clinically significant illness during the 4 weeks prior to dosing, that
             in the opinion of the investigator, would make the subject unsuitable for this study.

          -  History of any clinically significant surgery or procedure within 8 weeks of first
             dose, as determined by the investigator or expected to undergo a major surgical
             procedure during the trial.

          -  History of an allergic response(s) to PTH, PTH analogs, or PTH(1-34), or other
             clinically significant allergies, that in the opinion of the investigator, would make
             the subject unsuitable for this study.