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Trial · Interventional

CompletedPhase 3Results postedRegistry data

HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

Overview

Status
Completed
Phase
Phase 3
Enrollment
62 participants (actual)
Sponsor
Columbia University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Dec 2009
Primary completion
26 Jun 2017
Completion
26 Jun 2017
First posted
13 Sept 2010 (estimated)
Last update posted
5 Jul 2024
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102012201420162018
  1. Ph 3

    HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

    NCT01199614

    Dec 2009 to 26 Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open-label study of PTH(1-84) treatment that seeks: 1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis. 3. To establish the safety of PTH(1-84) when administered for up to 12 years. 4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism post PTH administration. There will be one visit conducted every six months in the study offices of the principal investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local Quest Lab performed to ensure stability prior to Baseline.

Interventions

  • open-label PTH(1-84)Drug

Arms1

  • Experimental

    open-label PTH(1-84)

    open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Dose of Calcium Supplementation

    Time frame · Baseline, up to 4 years

    Registry description

    Serum and urinary calcium levels maintained by change in requirements for calcium supplementation.

Secondary outcomes(1)
  1. Percent Change in BMD by DXA

    Time frame · Baseline, up to 4 years

    Registry description

    Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DXA)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, up to 4 years

Change in Dose of Calcium Supplementation

GroupValue (percent change in dose)Spread
Open-label PTH(1-84)3743
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline, up to 4 years

Percent Change in BMD by DXA

GroupValue (percent change in BMD)Spread
Open-label PTH(1-84)5.59

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Open-label PTH(1-84)open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day0 / 6225 / 6227 / 62

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2010

7 results

Therapy of hypoparathyroidism with intact parathyroid hormone.

Rubin et al. 2010Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 85

PMID 20094706PMC2947814DOI 10.1007/s00198-009-1149-xPUB-20094706

Rights unknown7 results

More studies

7 studies on this page

PubMed tag: none · 2022

Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.

Ayodele et al. 2022Advances in therapycited by 10

PMID 36018496PMC9525348DOI 10.1007/s12325-022-02292-1PUB-36018496

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2015

PTH(1-84) replacement therapy for the treatment of hypoparathyroidism.

Cusano et al. 2015Expert review of endocrinology & metabolismcited by 20

PMID 25705243PMC4334142DOI 10.1586/17446651.2015.971755PUB-25705243

Rights unknown
Source link

Indexing hint: Clinical trial · 2014

PTH(1-84) is associated with improved quality of life in hypoparathyroidism through 5 years of therapy.

Cusano et al. 2014The Journal of clinical endocrinology and metabolismcited by 80

PMID 24978675PMC4184077DOI 10.1210/jc.2014-2267PUB-24978675

Rights unknown
Source link

Indexing hint: Clinical trial · 2013

Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.

Cusano et al. 2013The Journal of clinical endocrinology and metabolismcited by 77

PMID 23162103PMC3537109DOI 10.1210/jc.2012-2984PUB-23162103

Rights unknown
Source link

PubMed tag: none · 2013

The effect of PTH(1-84) on quality of life in hypoparathyroidism.

Cusano et al. 2013The Journal of clinical endocrinology and metabolismcited by 89

PMID 23596139PMC3667253DOI 10.1210/jc.2013-1239PUB-23596139

Rights unknown
Source link

Indexing hint: Clinical trial · 2011

PTH(1-84) administration reverses abnormal bone-remodeling dynamics and structure in hypoparathyroidism.

Rubin et al. 2011Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 97

PMID 21735476PMC4019384DOI 10.1002/jbmr.452PUB-21735476

Rights unknown
Source link

PubMed tag: none · 2010

Hypoparathyroidism: clinical features, skeletal microstructure and parathyroid hormone replacement.

Rubin et al. 2010Arquivos brasileiros de endocrinologia e metabologiacited by 36

PMID 20485912PMC3702727DOI 10.1590/s0004-27302010000200019PUB-20485912

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
For Returning Participants or participants graduating from one of the parent studies: Inclusion Criteria: * Must have participated in and concluded the CL1-11-040, PAR-C10-007 or PAR-C10-008 Study at any site in the continental United States * Must have participated in and concluded the Hypopara Study at Columbia University Exclusion Criteria: * failure to have completed either of the inclusionary studies For New Participants (20 anticipated): INCLUSION CRITERIA: 1. Signed and dated informed consent form (ICF) before any study-related procedures are performed. 2. Adult males or females 18 to 85 years of age. 3. History of hypoparathyroidism for ≥ 18 months, including evidence of hypocalcemia and concomitant serum intact PTH concentrations below the lower limit of normal within 12 months prior to Baseline. 4. Requirement for calcitriol ≥0.25 mcg per day per day prior to Baseline. 5. Requirement for supplemental oral calcium ≥ 1500 mg per day between supplemental and dietary sources. 6. Serum thyroid function tests within normal laboratory limits at screening for all subjects not receiving thyroid hormone replacement therapy. For patients on thyroid hormone replacement therapy, the dose must have been stable for at least 3 months prior to screening 7. serum creatinine \< 1.5 mg/dL on a single measurement prior to use of study drug 8. Physically capable of performing daily subcutaneous (SQ) self-injections, in the thigh, of study medication (or have designee perform injection). 9. Willingness and ability to comply with the protocol (prior to screening). 10. With regard to female patients: Women of childbearing potential must have a negative pregnancy test at Screening and agree to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing at every scheduled visit. EXCLUSION CRITERIA: Patients who have any of the following during the screening visit are not eligible for enrollment in this study: 1. Known history of hypoparathyroidism resulting from an activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism). If unknown, it shall be assumed to be not-present. 2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease, insulin-dependent diabetes mellitus (IDDM) or poorly controlled Type II diabetes mellitus (HbA1C \> 8%), 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, primary or secondary hyperparathyroidism, a history of parathyroid carcinoma, hypopituitarism, acromegaly, or multiple endocrine neoplasia types I and II. 3. To be eligible, patients with a history of thyroid cancer must be documented to be disease-free for a period of at least 5 years (or 2 years with evidence of follow up and a doctor's note of clearance). 4. Patients dependent on regular parenteral calcium infusions (e.g. calcium gluconate) to maintain calcium homeostasis. 5. Patients that have undergone gastric resection or have active peptic ulcer disease requiring medical therapy. 6. Use of prohibited medications such as, raloxifene hydrochloride, lithium, methotrexate, or systemic corticosteroids within the last 6 months. 7. Treatment with PTH-like drugs, including PTH(1-84), PTH(1-34) or other N terminal fragments or analogs of PTH or PTH-related protein within the last 6 months. 8. Other drugs known to influence calcium and bone metabolism, such as calcitonin, sodium fluoride, or cinacalcet hydrochloride within the last 6 months. 9. Use of oral bisphosphonates within the previous 6 months or IV bisphosphonate preparations within the previous 12 months prior to screening. 10. Seizure disorder/epilepsy and a history of a documented seizure within the previous 6 months. 11. In regard to participants between 18 and 21 years of age: Presence of open epiphyses as determined by x-ray. 12. Radiotherapy to the skeleton within 5 years. 13. Serum 25-hydroxyvitamin D levels greater than 1.5-fold the laboratory upper limit of normal. (i.e., \> 150 ng/mL) 14. Any disease or condition in the opinion of the Investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements. 15. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 6 months prior to screening for this study. 16. Pregnant or lactating women. 17. History of diagnosed drug or alcohol dependence within the previous 3 years. 18. Clinical history of renal calculi within the past 6 months. 19. Any condition that negatively affects gastrointestinal absorption, including but not limited to short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease. 20. Chronic/severe cardiac disease including but not limited to cardiac insufficiency, arrhythmias, bradycardia (resting heart rate \< 60 beats/minute), or hypotension (systolic and diastolic blood pressures \< 100 and 60 mmHg, respectively). 21. History of cerebrovascular accident (CVA) in the past 5 years or earlier, if there is residual impairment that would affect participation in the study.

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