Status:
TERMINATED
Effects of PTH Replacement on Bone in Hypoparathyroidism
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Hypoparathyroidism
DiGeorge Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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....
Detailed Description
Objectives The primary objective of this study is to evaluate the skeletal effects of hormone replacement therapy with HPTH in hypoparathyroidism. Study Population This study will enroll up to 69 s...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age eligibility at screening:
- Premenopausal women: aged 18 to 45 years,
- 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.
- Men: aged 18 to 70 years,
- 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:
- Moderate to severe hepatic disease defined as hepatic transaminases (ALT and AST) \> 2 times the upper limit of normal
- Severe renal insufficiency defined as a calculated GFR \< 25 mL/min/1.73 m(2), using the CKD-EPI equation(15).
- Allergy or intolerance to tetracycline antibiotics
- 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.).
- Perimenopausal defined by no menses for 6 months to 5 years and an FSH \> 20 U/L at the screening and/or baseline visits..
- Chronic diseases that might affect mineral metabolism such as diabetes, celiac disease, Crohn s disease, Cushing s syndrome, or adrenal insufficiency
- Concurrent treatment with doses of thyroid hormone intended to suppress thyroid stimulating hormone below the assay s detection limit or persistent thyroid cancer
- 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
- History of retinoblastoma or Li-Fraumeni syndrome
- History of treatment with bisphosphonates, calcitonin, tamoxifen, selective-estrogen receptor modulators, or directed skeletal irradiation
- Use of oral or intravenous corticosteroids or estrogen replacement therapy for more than 3 weeks within the last 6 months
- Use of depot medroxyprogesterone for contraception within the past 12 months
- Chronic inadequate biochemical control with conventional therapy and/or calcium infusion dependent
- Seizure disorder requiring antiepileptic medications
- Treatment with PTH for more than 2 weeks continuously at any time, prior to study entry
- Any cognitive impairment that limits the subject s ability to comply, independently or through the assistance of a legally authorized representative, with protocol procedures.
- Open epiphyses as determined by an X-ray of the hand and wrist in subjects \< 21 years of age.
Exclusion
Key Trial Info
Start Date :
October 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00395538
Start Date
October 30 2006
End Date
October 4 2017
Last Update
August 28 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892