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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK069350 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Whereas much information is known about the properties of bone in primary hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The purpose of this research project is to test the hypothesis that the skeleton in hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and microarchitectural features. We will also test the hypothesis that the skeleton is dependent upon PTH for normal structure and function. Using non-invasive approaches as well as direct analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized. With each patient serving as his/her own control, we will determine how, to what extent, and in what ways the administration of PTH restores skeletal dynamics and structure to the hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH action on bone gained by our many years of studying PTH overexpression in primary hyperparathyroidism. This investigation may also provide insight into the means by which PTH helps to restore the skeleton when it is used to treat osteoporosis.
A detailed description of the methods used in this study include the following: direct analysis of bone itself. skeletal dynamics and structure such as dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH(1-84) | Experimental | 100mcg of PTH1-84 every other day, every day, or every three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTH | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Requirements for Calcium Supplementation | Serum and urinary calcium levels maintained by change in requirements for calcium supplementation | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in BMD From Baseline to 24 Months by DXA | Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA). | baseline versus 24 months |
| Trabecular Width | Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Bilezikian, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29972871 | Derived | Rubin MR, Zhou H, Cusano NE, Majeed R, Omeragic B, Gomez M, Nickolas TL, Dempster DW, Bilezikian JP. The Effects of Long-term Administration of rhPTH(1-84) in Hypoparathyroidism by Bone Histomorphometry. J Bone Miner Res. 2018 Nov;33(11):1931-1939. doi: 10.1002/jbmr.3543. Epub 2018 Aug 16. |
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The first 6 participants in the study were randomly assigned to PTH1-84 100mcg daily, 100mcg every other day, and 100mcg every three days as a pilot project to determine the correct dosing regimen.
68 subjects were enrolled from 05/12/2004 to 06/19/2014 at Columbia University Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | PTH1-84 | participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
hypoparathyroidism patients who signed Consent to participate in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | PTH1-84 | participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Requirements for Calcium Supplementation | Serum and urinary calcium levels maintained by change in requirements for calcium supplementation | Only the first 30 participants to complete 24 months in the study were analyzed | Posted | Mean | Standard Deviation | grams per day of calcium supplementation | 2 years |
|
|
earliest SAE report is 8/2/05 and latest SAE report is 6/19/09
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTH1-84 | participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection at bone biopsy site | Infections and infestations | MedDRA (10.0) | Systematic Assessment | secondary to participation in study but unrelated to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety/Irritabilty/Stress | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
Only 16 subjects received a bone biopsy, which is why many of the measurements were only analyzed in 16 subjects. In total, data was only analyzed for the first 30 subjects analyzed for data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P. Bilezikian MD | Columbia University Medical Center | 212-305-2663 | jpb2@columbia.edu |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| baseline versus two years |
| Trabecular Number | trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | baseline versus two years |
| Cortical Porosity | Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | baseline versus two years |
| Mineralizing Surface | Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | baseline versus one year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Percent Change in BMD From Baseline to 24 Months by DXA | Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA). | Only the first 30 participants who completed 24 months of the study were analyzed | Posted | Mean | Standard Deviation | percentage of change to BMD | baseline versus 24 months |
|
|
|
| Secondary | Trabecular Width | Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | Posted | Mean | Standard Deviation | micrometers | baseline versus two years |
|
|
|
| Secondary | Trabecular Number | trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | Posted | Mean | Standard Deviation | mm^-1 | baseline versus two years |
|
|
|
| Secondary | Cortical Porosity | Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment. | Posted | Mean | Standard Deviation | percentage of porosity | baseline versus two years |
|
|
|
| Secondary | Mineralizing Surface | Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed. | Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment. | Posted | Mean | Standard Deviation | percentage of surface | baseline versus one year |
|
|
|
| 15 |
| 68 |
| 68 |
| 68 |
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| Right Kidney mass | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment | unlikely to be related to study participation |
|
| Abdominal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | categorized as an SAE because it involved hospitalization. unrelated to study participation |
|
| pancreatitis, accute | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | not related to study participation |
|
| ampullary mass | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment | unrelated to study participation |
|
| anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | categorized as a Serious Adverse Event because it involved hospitalization. unrelated to study participation |
|
| angina | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment | categorized as an SAE because it involved hospitalization unlikely to be related to study participation |
|
| concussion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | concussion secondary to car accident categorized as an SAE because it involved hospitalization unrelated to study participation |
|
| damage to surgical site of recent hernia repair | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment | patient fell and damaged the surgical site of a recent hernia repair categorized as an SAE because it involved hospitalization unrelated to study participation |
|
| dehydration | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | patient hospitalized with dehydration unrelated to study participation |
|
| cyst removal | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | unrelated to study participation |
|
| symptomatic hypocalcemia | Endocrine disorders | MedDRA (10.0) | Systematic Assessment | though hypocalcemia is an anticipated syndrome of hypoparathyroidism, this event resulted in hospitalization unrelated to study participation |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | categorized as a SAE because it involved hospitalization unrelated to study participation |
|
| laryngeal spasm | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | categorized as an SAE because it involved hospitalization unrelated to study participation |
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| Fainted | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment | Due to GERD |
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| L Oophorectomy | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Elective Surgery | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Rash locations vary from patient to patient, areas reported were face and cheeks, arms and legs and coccyx areas. |
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| Bruising at injection site | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Chest Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cold/Flu Virus/Symptoms | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment | This adverse event refers to patients who had experienced either cold and flu virus's or symptoms |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Decrease in Urination | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Fatigue | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Headache/Migraine | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Temperature Sensitivity | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypercalcemia | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypertension | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Increased Urination | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal Irritability | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Weight Fluctuations | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Increased Thirst | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Confusion\Disorientation | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bone Fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Body Swelling | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cysts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Kidney Stone/Kidney Pain | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Opthalmological Irritability/Visual Impairment | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypocalcemic Symptoms | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|