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Effects of PTH Replacement on Bone in Hypoparathyroidism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395538
First Posted: November 3, 2006
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
  Purpose

Hypoparathyroidism is a rare condition associated with a low level of parathyroid hormone (PTH) in the blood. Hypoparathyroidism can be genetic and show up in childhood, or it can occur later in life. If it occurs later, it is usually due to damage or removal of the parathyroid glands during neck surgery. PTH helps control the amount of calcium in blood, kidneys, and bones. Low levels of calcium in the blood can cause a person to feel sick. It can cause cramping or tingling in the hands, feet, or other parts of the body. A very low blood calcium can cause fainting or seizures.

The standard treatment for hypoparathyroidism is a form of vitamin D (calcitriol) and calcium supplements. Keeping normal blood levels of calcium can be difficult. Sometimes there is too much calcium in the urine even if the calcium levels in the blood are low. High calcium in the kidneys and urine can cause problems such as calcium deposits in the kidney (nephrocalcinosis) or kidney stones. High levels of calcium in the kidney may keep the kidney from functioning normally. Treatment with PTH will replace the hormone you are missing. Your disease may be better controlled on PTH than on calcium and calcitriol.

Researchers at the NIH have conducted prior studies to establish synthetic human parathyroid hormone 1-34 (HPTH) as a treatment for hypoparathyroidism. Other studies have shown that PTH may improve calcium levels in blood and urine. The primary purpose of this research study is to evaluate the effects of synthetic human parathyroid hormone 1-34 (HPTH) replacement therapy on bone in adults and teenagers with hypoparathyroidism.

The study takes 5 (Omega) years to complete and requires 12 inpatient visits to the National Institutes of Health Clinical Center in Bethesda, MD. The first visit will help the study team decide whether you are eligible. This visit will last 2 to 3 days. After taking calcium and calcitriol for 1 - 7 months you will return to the NIH Clinical Center for the baseline visit. The baseline visit is the visit that you will start your PTH; you will also undergo a bone biopsy during the visit. The baseline visit may last 7 to 10 days. You will then take PTH twice a day for 5 years. You will be asked to return to the NIH clinical center every 6 months for 10 follow-up visits. During one of the follow-up visits, you will have a second bone biopsy taken from the other hip. That second biopsy will be done after 1 year, 2 years, or 4 years of taking PTH; the researchers will assign the timing of the second biopsy randomly. You will be asked to go to your local laboratory for blood and urine tests between each follow up visit. At first the blood tests will occur at least once a week. Later, you will need to go to your local laboratory for blood tests at least once a month and urine tests once every 3 months. The local laboratory visits and follow-up visits at the NIH Clinical Center will help the study team determine whether the HPTH treatment is controlling your hypoparathyroidism.


Condition Intervention Phase
Hypoparathyroidism DiGeorge Syndrome Drug: PTH 1-34 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of PTH Replacement on Bone in Hypoparathyroidism

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):

Primary Outcome Measures:
  • Iliac crest bone biopsy [ Time Frame: Baseline and 1,2 or 4yrs ]

Secondary Outcome Measures:
  • Bone mineral density distribution [ Time Frame: Baseline and 1,2 or 4 yrs ]
  • Biochemical changes [ Time Frame: Every 6 months ]
  • 6-minute walk test [ Time Frame: Every 6 months ]
  • Questionnaires [ Time Frame: Every 6 months ]
  • CT Densitometry [ Time Frame: Annually ]
  • Renal US and CT [ Time Frame: Annually ]
  • DXA [ Time Frame: Every 6 months ]

Enrollment: 46
Study Start Date: October 30, 2006
Study Completion Date: October 4, 2017
Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Biopsy
Subjects are randomized to have the second bone biopsy done 1,2, or 4 years after the start of PTH.
Drug: PTH 1-34
Given twice daily by subcutaneous

  Show Detailed Description

  Eligibility

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 to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age eligibility at screening:

      1. Premeopausal women: aged 18 to 45 years,
      2. Postmenopausal women: aged greater than or equal to 53 years to 70 years and 5 years since last menses. For women without a uterus, subjects must have a clinical history of menopause for at least 5 years and an FSH greater than 30 U/L.
      3. Men: aged 18 to 70 years,
    2. Physician-diagnosed hypoparathyroidism of at least 1-year duration, confirmed by medical record review. The investigators will confirm the diagnosis during the screening visit at which time the subject must have an intact PTH < 30 pg/mL.

EXCLUSION CRITERIA:

  1. Moderate to severe hepatic disease defined as hepatic transaminases (ALT and AST) > 2 times the upper limit of normal
  2. Severe renal insufficiency defined as a calculated GFR < 25 mL/min/1.73 m(2), using the CKD-EPI equation(15).
  3. Allergy or intolerance to tetracycline antibiotics
  4. Pregnant or lactating or planning to become pregnant during the course of the study. (Women who are able to get pregnant must agree to use an effective form of birth control while in this study.).
  5. Perimenopausal defined by no menses for 6 months to 5 years and an FSH > 20 U/L at the screening and/or baseline visits..
  6. Chronic diseases that might affect mineral metabolism such as diabetes, celiac disease, Crohn s disease, Cushing s syndrome, or adrenal insufficiency
  7. Concurrent treatment with doses of thyroid hormone intended to suppress thyroid stimulating hormone below the assay s detection limit or persistent thyroid cancer
  8. History of a skeletal disease unrelated to hypoparathyroidism, such as osteoporosis or low bone density (defined as a DXA Z-Score < -2 in all subjects or T-score < -2 in subjects greater than or equal to 20 year old), osteosarcoma, Paget s disease, alkaline phosphatase > 1.5 times the upper limit of normal, or metastatic bone disease
  9. History of retinoblastoma or Li-Fraumeni syndrome
  10. History of treatment with bisphosphonates, calcitonin, tamoxifen, selective-estrogen receptor modulators, or directed skeletal irradiation
  11. Use of oral or intravenous corticosteroids or estrogen replacement therapy for more than 3 weeks within the last 6 months
  12. Use of depot medroxyprogesterone for contraception within the past 12 months
  13. Chronic inadequate biochemical control with conventional therapy and/or calcium infusion dependent
  14. Seizure disorder requiring antiepileptic medications
  15. Treatment with PTH for more than 2 weeks continuously at any time, prior to study entry
  16. Any cognitive impairment that limits the subject s ability to comply, independently or through the assistance of a legally authorized representative, with protocol procedures.
  17. Open epiphyses as determined by an X-ray of the hand and wrist in subjects < 21 years of age.
  Contacts and Locations
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): NCT00395538


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Rachel I Gafni, M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00395538     History of Changes
Other Study ID Numbers: 070016
07-D-0016
First Submitted: November 2, 2006
First Posted: November 3, 2006
Last Update Posted: October 19, 2017
Last Verified: March 14, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Parathyroid
Bone Biopsy
Calcium-Sensing Receptor
Bone Density
Bone Turnover
Hypoparathyroidism

Additional relevant MeSH terms:
Hypoparathyroidism
DiGeorge Syndrome
Parathyroid Diseases
Endocrine System Diseases
22q11 Deletion Syndrome
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Lymphatic Abnormalities
Lymphatic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn