Status:
COMPLETED
OPG/Soluble RANKL (sRANKL) and Bone Mineral Density in Primary Hyperparathyroidism
Lead Sponsor:
Wroclaw Medical University
Collaborating Sponsors:
Ministry of Science and Higher Education, Poland
Conditions:
Primary Hyperparathyroidism
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether osteoprotegerin and RANKL (receptor activator of nuclear factor-κB ligand) are involved in bone remodeling in patients with primary hyperparathyroidis...
Detailed Description
Study background and rationale Receptor activator of nuclear factor-κB (RANK), RANK ligand (RANKL) and its decoy receptor osteoprotegerin (OPG) play key roles in regulating bone turnover. They are in...
Eligibility Criteria
Inclusion
- Clinical diagnosis of primary hyperparathyroidism
- Subjects able and willing to comply with the requirements of the protocol
Exclusion
- Other diseases and medications known to interfere with bone or mineral metabolism, especially bisphosphonates used during the two-year period before this study
- Evidence of active malignancy
- Significant renal impairment as indicated by serum creatinine levels above the normalized range for age
- Significant hepatic dysfunction
- Malabsorption syndrome
- Active gastroduodenal ulcers
- Actual or planned pregnancy (in alendronate group females must not be planning to conceive during the two years following the study) or breast-feeding
- The lack of effective non-hormonal contraception in females with child-bearing capability (in alendronate group)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01889134
Start Date
January 1 2009
End Date
October 1 2012
Last Update
June 28 2013
Active Locations (1)
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1
Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University
Wroclaw, Poland, 50-367