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

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ClinicalTrials.gov Identifier: NCT01889134
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Jadwiga Szymczak, Wroclaw Medical University

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

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Drug: Sedron (alendronate) Procedure: Parathyroidectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in osteoprotegerin/sRANKL ratio at month 12 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes from baseline in bone mineral density values at month 12 [ Time Frame: 12 months ]
  2. Change from baseline in PTH serum concentration at month 12 [ Time Frame: 12 months ]


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT01889134


Locations
Poland
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
Investigators
Principal Investigator: Jadwiga W Szymczak, PhD, MD Wroclaw Medical University, Poland

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 ( Other Grant/Funding Number: Ministry of Science and Higher Education, Poland )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by Jadwiga Szymczak, Wroclaw Medical University:
primary hyperparathyroidism
RANKL
osteoprotegerin
bone mineral density
alendronate
parathyroidectomy

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