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

This study has been completed.
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Jadwiga Szymczak, Wroclaw Medical University
ClinicalTrials.gov Identifier:
First received: June 21, 2013
Last updated: June 25, 2013
Last verified: June 2013
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.

Condition Intervention
Primary Hyperparathyroidism
Drug: Sedron (alendronate)
Procedure: Parathyroidectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Osteoprotegerin/sRANKL Ratio and Bone Mineral Density in Patients With Primary Hyperparathyroidism Treated With Parathyroidectomy or Alendronate

Resource links provided by NLM:

Further study details as provided by Wroclaw Medical University:

Primary Outcome Measures:
  • Change from baseline in osteoprotegerin/sRANKL ratio at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in bone mineral density values at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in PTH serum concentration at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate
Sedron (alendronate) 70 mg taken orally once a week for 12 months
Drug: Sedron (alendronate)
Other Name: Alendronate
Active Comparator: Parathyroidectomy
Selective parathyroidectomy
Procedure: Parathyroidectomy
No Intervention: Control group
No intervention

  Show Detailed Description


Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01889134

Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University
Wroclaw, Poland, 50-367
Sponsors and Collaborators
Wroclaw Medical University
Ministry of Science and Higher Education, Poland
Principal Investigator: Jadwiga W Szymczak, PhD, MD Wroclaw Medical University, Poland
  More Information

No publications provided

Responsible Party: Jadwiga Szymczak, assistant professor, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT01889134     History of Changes
Other Study ID Numbers: GR-722/2009  NN 402 309 536 
Study First Received: June 21, 2013
Last Updated: June 25, 2013
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Wroclaw Medical University:
primary hyperparathyroidism
bone mineral density

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Endocrine System Diseases
Parathyroid Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2016