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

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ClinicalTrials.gov Identifier: NCT02781844
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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® and in the EU as Natpar).

Condition or disease Intervention/treatment Phase
Hypoparathyroidism Drug: 25mcg rhPTH(1-84) Drug: 50mcg rhPTH(1-84) Drug: 100mcg rhPTH(1-84) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism
Actual Study Start Date : March 11, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: A/B or B/A
Participants will be randomized to either receive 25 microgram (mcg) rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 25mcg rhPTH(1-84) BID with no calcium for treatment period 2
Drug: 25mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3.
Other Name: PTH

Drug: 100mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
Other Name: PTH

Experimental: C/B or B/C
Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 2
Drug: 50mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4
Other Name: PTH

Drug: 100mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
Other Name: PTH

Experimental: D/E or E/D
Participants will be randomized to either receive 25mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 25mcg rhPTH(1-84) twice daily with calcium for treatment period 2
Drug: 25mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3.
Other Name: PTH

Drug: 100mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
Other Name: PTH

Experimental: F/E or E/F
Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with calcium for treatment period 2
Drug: 50mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4
Other Name: PTH

Drug: 100mcg rhPTH(1-84)
Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
Other Name: PTH




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30 minutes (m), 1, 1.5, 2, 4, 8, 12, 16 and 24 hours (h) post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The Cmax of rhPTH(1-84) will be assessed.

  2. Time of Maximum Concentration (Tmax) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The Tmax of rhPTH(1-84) will be assessed.

  3. Area Under the Concentration Curve in Plasma Over Time Interval From Time Zero to the Last Measurable Concentration (AUC0-t) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The AUC0-t of rhPTH(1-84) will be assessed.

  4. Area Under the Concentration Curve in Plasma Over Time Interval From Zero To Infinity (AUC0-inf) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The AUC0-inf of rhPTH(1-84) will be assessed.

  5. Area Under the Concentration Curve in Plasma Over Time Interval From Time Zero to 24 Hours Post the First Dose (AUC0-24h) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The AUC0-24h of rhPTH(1-84) will be assessed.

  6. Elimination Rate Constant (Kel) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The Kel of rhPTH(1-84) will be assessed.

  7. Apparent Clearance (CL/F) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The CL/F of rhPTH(1-84) will be assessed.

  8. Apparent Volume of Distribution (Vz/F) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The Vz/F of rhPTH(1-84) will be assessed.

  9. Elimination Half-Life (t1/2) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The t1/2 of rhPTH(1-84) will be assessed.

  10. Area Under the Concentration Curve in Plasma Over Time Interval From Time Zero to 24 Hours (AUC0-24h) of Serum Calcium After Intake of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The AUC0-24h of serum calcium multiple doses of rhPTH(1-84) will be assessed.

  11. Time to Maximum Effect (TEmax) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The TEmax of multiple doses of rhPTH(1-84) will be assessed.

  12. Maximum Effect (Emax) of rhPTH(1-84) [ Time Frame: QD Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12, 16 and 24 h post-dose BID Regimen: Pre-dose, 10, 20, 30m, 1, 1.5, 2, 4, 8, 12h, 12h 10m, 12h 20m, 12h 30m, 13h, 13h 30m, 14, 16, 20, 22, 24, 28, and 36 h post-dose ]
    The Emax of multiple doses of rhPTH(1-84) will be assessed.

  13. Renal Excretion [ Time Frame: QD Regimen: Pre-dose to 24h post-dose BID Regimen: Pre-dose to 36h post-dose ]
    Total amount of sodium, calcium, magnesium, citrate, phosphate, cyclic adenosine monophosphate (cAMP), and creatinine in each sample will be assessed.

  14. Renal Excretions Relative to the Total Amount of Creatinine Excreted [ Time Frame: QD Regimen: Pre-dose to 24h post-dose BID Regimen: Pre-dose to 36h post-dose ]
    Total amount of sodium, calcium, magnesium, citrate, cAMP, and phosphate excreted in each sample relative to the total amount of creatinine excreted will be assessed.

  15. Renal Clearance [ Time Frame: QD Regimen: Pre-dose to 24h post-dose BID Regimen: Pre-dose to 36h post-dose ]
    Renal clearance of sodium, calcium, magnesium, citrate, creatinine, and phosphate will be assessed.

  16. Fractional Excretion [ Time Frame: QD Regimen: Pre-dose to 24h post-dose BID Regimen: Pre-dose to 36h post-dose ]
    Fractional excretion of sodium, calcium, citrate, magnesium, and phosphate will be assessed.


Secondary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration up to 65 days ]
    An AE is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  2. Ability to voluntarily provide written, signed, and dated informed consent as applicable to participate in the study.
  3. Adult men or women aged greater than or equal (>=) 18 years at the time of consent. The date of participant signature of the informed consent is defined as the beginning of the Screening Period. The Screening Period for this study may encompass both the Administrative Screening Period (if needed) and the Clinical Screening Period. For purposes of this inclusion criterion, age will only be assessed at the time the informed consent is first signed by the study participant.
  4. History of hypoparathyroidism for >=12 months, post-diagnosis, inclusive of historical biochemical evidence of hypocalcemia with concomitant serum intact parathyroid hormone (PTH) concentrations below the lower limit of the laboratory normal range.
  5. Requirement for supplemental oral calcium treatment >=1000 milligrams (mg) elemental calcium per day.
  6. Requirement for therapy with active forms of vitamin D at a minimum dose of >=0.25 microgram (mcg) per day (that is, >=0.25 mcg calcitriol or equivalent per day).
  7. Serum calcium level within the laboratory normal reference range based on clinical chemistry lab results at the Clinical Screening Visit (based on central and/or local lab results) and Treatment Period 1, Day -2 (based on central and/or local lab results), or if outside of normal range, considered not clinically significant by the investigator.
  8. Urinary calcium excretion >=200mg (5 millimolar [mmol])/24 hour (h), based on a 24-hour collection, collected anytime during the Clinical Screening Period, but prior to check-in to the Clinical Research Center (CRC) at Treatment Period 1, Day -2 (based on central and/or local lab results).
  9. Serum magnesium level within the laboratory normal range at the Clinical Screening Visit or, if outside of normal range, considered not clinically significant by the investigator.
  10. Serum thyroid function tests within normal laboratory limits at the Clinical Screening Visit, or, if outside of normal range, considered as not clinically significant by the investigator.
  11. Serum 25-hydroxyvitamin D (25(OH)D) level between the lower limit of normal and 1.5-fold the laboratory upper limit of normal, or, if outside of this range, considered not clinically significant by the investigator, at the Clinical Screening Visit.
  12. Serum creatinine less than (<) 1.5 mg/ decilitre (dL) (<133 micromole [mmol]/ litre [L]) AND estimated creatinine clearance greater than (>) 60 millilitre (mL)/minute (>1.002mL/ Second [s]) at the Clinical Screening Visit, and serum creatinine <1.5 mg/dL (<133mmol/L) at Treatment Period 1, Day -2.
  13. Male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria:

  1. Participation in any other investigational drug study in which the last dose of investigational drug occurred within 3 months prior to Day 1 of Treatment Period 1 (or within 5 half-lives, if elimination half-life is greater than 18 days).
  2. 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 as determined by the investigator.
  3. Known history of hypoparathyroidism resulting from an activation mutation in the calcium sensing receptor (CaSR) gene or impaired responsiveness to PTH (pseudohypoparathyroidism).
  4. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis 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, as determined by the investigator.

5 . In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid hormone exposure levels ranging from 3 to 71 times the exposure levels in humans receiving a 100 mcg dose of rhPTH(1-84). Therefore, participant who are at increased baseline risk for osteosarcoma such as participant with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult participants with open epiphyses, participants with hereditary disorders predisposing to osteosarcoma or participant with a prior history of external beam or implant radiation therapy involving the skeleton are excluded.

6. Participants who have a known history of hypercalcemia during initiation of treatment with PTH, PTH analogues or fragments of PTH.

7. Participants who have a known history of hypocalcemia following abrupt withdrawal of treatment with PTH, PTH analogues or fragments of PTH.

8. Participant dependent on regular parenteral calcium infusions (example, calcium gluconate) to maintain calcium homeostasis within 3 months prior to enrollment, as determined by the investigator.

9. Use of the following medications prior to administration of investigational product within: 14 days- thiazide diuretics; 30 days - loop diuretics, lithium, systemic corticosteroids (medical judgment is required by the investigator. Primarily high doses of systemic corticosteroids [example, prednisone] should be excluded. Stable doses of hydrocortisone [example, as treatment for Addison's disease] may be acceptable); 3 months - calcitonin, cinacalcet hydrochloride, treatment with rhPTH(1-84) or N-terminal PTH or PTH-related peptide fragments or analogs; For females: changes in hormone replacement therapy within 3 months are excluded. Stable (>=3 months) hormone replacement therapy is acceptable; 6 months - fluoride tablets, oral bisphosphonates, methotrexate, growth hormone, digoxin, raloxifene or similar selective estrogen receptor modulators (SERMs); 12 months - intravenous bisphosphonates, drug or alcohol abuse, as determined by the investigator.

10. Presence of any clinically significant results from laboratory tests, vital signs assessments, or electrocardiograms (ECGs), as judged by the investigator.

11. Twelve-lead ECG values (average of triplicate readings) demonstrating QTc>450 millisecond (msec) (males) or >470 msec (females) at the Clinical Screening Visit and/or any time points up to and including predose of Day 1 (Period 1).

12. Any medical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for this study.

13. Positive test result for any of the following viral infections at the Clinical Screening Visit: Hepatitis B surface antigen; hepatitis C; human immunodeficiency virus (HIV) 14. Known significant bleeding diathesis that could preclude multiple venipunctures as determined by the investigator.

15. Participants who have donated a total of 100 mL to 499 mL of whole blood within 30 days prior to dosing, or participants who have donated a total of more than 499 mL of whole blood within 56 days prior to dosing.

16. A positive screen for drugs of abuse at the Clinical Screening Visit, and/or a positive screen for drugs of abuse and alcohol at check-in to the CRC at Treatment Period 1. Participants taking prescription medications that might be detected during the urine screen for drugs of abuse may be enrolled per the investigator's medical judgment.

17. History of a clinically significant illness during the 4 weeks prior to dosing (as determined by the investigator).

18. History of any clinically significant surgery or procedure within the past 8 weeks, as determined by the investigator.

19. History of an allergic response(s) to PTH or PTH analogs, or other clinically significant allergies, as determined by the investigator.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781844


Contacts
Contact: Shire Contact 1 866-842-5335 clinicaltransparency@shire.com

Locations
United States, California
Providence Clinical Research Recruiting
North Hollywood, California, United States, 91606
Contact: Site Contact    818-558-7555    tsligh@providenceclinical.com   
Principal Investigator: Teresa Sligh, MD         
United States, Illinois
University of Chicago Medical Center Withdrawn
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Contact    317-278-7826    mpeacock@iu.edu   
Principal Investigator: Munro Peacock, MD         
United States, Kentucky
University Of Kentucky School of Medicine Recruiting
Lexington, Kentucky, United States, 40536-0298
Contact: Site Contact    859-323-6652    kenneth.ain@UKY.edu   
Principal Investigator: Kenneth Ain, MD         
United States, Louisiana
Crescent City Clinical Research Center, LLC Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Contact    504-812-3366    jwisemd@gmail.com   
Principal Investigator: Jonathan Wise, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site contact    617-726-3966    mannstadt@mgh.harvard.edu   
Principal Investigator: Michael Mannstadt, MD         
United States, Minnesota
Mayo Clinic - PPDS Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Contact    507-266-4322    clarke.bart@mayo.edu   
Principal Investigator: Bart Clarke, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Site Contact    212-305-0066    mrr6@cumc.columbia.edu   
Principal Investigator: Mishaela Rubin, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43201
Contact: Site Contact    614-685-3341    steven.ing@osumc.edu   
Principal Investigator: Steven Ing, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Site Contact    215-955-1978    intekhab.ahmed@jefferson.edu   
Principal Investigator: Intekhab Ahmed, MD         
United States, Tennessee
New Orleans Center for Clinical Research (NOCCR) - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Site Contact    865-305-9100    wbsmd@noccr.com   
Principal Investigator: William Smith, MD         
Canada
CHU de Quebec-Universite Laval Recruiting
Quebec, Canada, G1V 4G2
Contact: Site Contact    (418) 525-4444 ext 48535    claudia.gagnon@crchudequebec.ulaval.ca;claudia.gagnon@fmed.ulaval.ca   
Principal Investigator: Claudia Gagnon, MD         
Denmark
Aarhus Universitetshospital Recruiting
Aarhus N, Central Jutland, Denmark, 8200
Contact: Site Contact    +4523329135    lars.rejnmark@rm.dk   
Principal Investigator: Lars Rejnmark, MD         
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Recruiting
Szeged, Csongrád, Hungary, 6720
Contact: Site Contact    +3662545186    takacs.robert@med.u-szeged.hu   
Principal Investigator: Robert Takacs, MD, PhD         
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Contact: Site Contact    +3612100278 ext 51520    takacs.istvan@med.semmelweis-univ.hu   
Principal Investigator: Istvan Takacs, MD, PhD         
Pécsi Tudományegyetem Recruiting
Pécs, Hungary, 7624
Contact: Site Contact    +3672536145    habon.tamas@pte.hu   
Principal Investigator: Tamas Habon, MD         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire

Additional Information:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02781844     History of Changes
Other Study ID Numbers: SHP634-101
2015-004757-40 ( EudraCT Number )
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Calcium, Dietary
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents