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

NCT01889134 | Completed

• 2 other identifiers: GR-722/2009NN 402 309 536
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperparathyroidism

Keywords

primary hyperparathyroidism; RANKL; osteoprotegerin; bone mineral density; alendronate; parathyroidectomy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in osteoprotegerin/sRANKL ratio at month 12

  12 months

Secondary Outcomes (2)

• Changes from baseline in bone mineral density values at month 12

  12 months

• Change from baseline in PTH serum concentration at month 12

  12 months

Study Arms (3)

Alendronate

EXPERIMENTAL

Sedron (alendronate) 70 mg taken orally once a week for 12 months

Drug: Sedron (alendronate)

Parathyroidectomy

ACTIVE COMPARATOR

Selective parathyroidectomy

Procedure: Parathyroidectomy

Control group

NO INTERVENTION

No intervention

Interventions

Sedron (alendronate) DRUG

Also known as: Alendronate

Alendronate

Parathyroidectomy PROCEDURE

Parathyroidectomy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of primary hyperparathyroidism
• Subjects able and willing to comply with the requirements of the protocol

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University

Wroclaw, 50-367, Poland

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Alendronate; Parathyroidectomy

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jadwiga W Szymczak, PhD, MD

  Wroclaw Medical University (Poland)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

PL (1)