OPG/Soluble RANKL (sRANKL) and Bone Mineral Density in Primary Hyperparathyroidism

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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 hyperparathyroidism (PHPT), and whether alendronate may be useful in treatment of the patients with PHPT who are not treated with parathyroidectomy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wroclaw Medical University
• Collaborator: Ministry of Science and Higher Education, Poland
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• Clinical diagnosis of primary hyperparathyroidism

• Subjects able and willing to comply with the requirements of the protocol

Exclusion Criteria:

• 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)