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Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate

This study is currently recruiting participants.
Verified April 2010 by Medical University of Vienna
Sponsor:
Collaborator:
National Bank of Austria
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01222026
First received: October 15, 2010
Last updated: July 20, 2011
Last verified: April 2010
History of Changes
  Purpose

Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT.

Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.


Condition Intervention Phase
Cured Primary Hyperparathyroidism, Concommitant Osteopenia or Osteoporosis
 Drug: Strontium Ranelate + Ca/Vitamin-D
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Bone mineral density measurement of the Lumbar spine [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density of the femoral neck [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bone mineral density of the radius [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Osteoprotegerin (OPG/OCIF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • RANKL (OPG-ligand) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • cathepsin K (cat K) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • ionised calcium (Ca++) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • phosphate (PO4-) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • alkaline phosphatase (AP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • bone-specific alkaline phosphatase (BAP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • osteocalcin (Oc) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • parathyroid hormone (PTH) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strontium Ranelate
Receiving Strontium Ranelate + Ca/Vitamin-D
 Drug: Strontium Ranelate + Ca/Vitamin-D
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
Other Name: Protelos (r)
Placebo Comparator: Placebo
Receiving Placebo + Ca/Vitamin D
 Drug: Placebo
Placebo 1000mg Calcium 800 IE Vitamin-D

Detailed Description:

The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density.

After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate.

Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biochemically proven PHPT, PTX planned
  • osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]

Exclusion Criteria:

  • Premenopausal women
  • Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
  • Persisting or recurrent PHPT (postoperative hypercalcemia)
  • Four-gland hyperplasia
  • Multiple endocrine neoplasia (MEN) or hereditary PHPT
  • Familial hypocalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
  • Anamnestic pulmonal embolism or deep venous thrombosis
  • Blood coagulation disorder or coagulopathy
  • Phenylketonuria
  • Renal impairment (creatinine clearance <30ml/h)
  • Severe hepatic disorder
  • Severe systemic disorder
  • Thyroid dysfunction
  • Immobilisation
  • Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
  • Known allergy against any component of the study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222026

Contacts
Contact: Bruno Niederle, Prof, MD 0043 40400 6943 chir-endokrin@meduniwien.ac.at
Contact: Christian Scheuba, Prof, MD 0043 40400 6943 christian.scheuba@meduniwien.ac.at

Locations
Austria
Medical University Vienna, General Hospital Vienna (AKH Wien) Recruiting
Vienna, Austria, 1090
Contact: Bruno Niederle, Prof., MD.     0043 40400 6943     chir-endokrin@meduniwien.ac.at    
Contact: Christian Scheuba, Prof., MD     0043 40400 6943     christian.scheuba@meduniwien.ac.at    
Sub-Investigator: Reza Asari, MD            
Principal Investigator: Bruno Niederle, Prof., MD            
Sub-Investigator: Christian Scheuba, Prof, MD            
Sub-Investigator: Philipp Riss, MD            
Sub-Investigator: Martin B Niederle, MD            
Sub-Investigator: Christian Bieglmayer, Prof, MD            
Sub-Investigator: Katharina Kerschan-Schindl, Prof, MD            
Sub-Investigator: Peter Pietschmann, Prof, MD            
Sponsors and Collaborators
Medical University of Vienna
National Bank of Austria
Investigators
Principal Investigator: Bruno Niederle, Prof., MD Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Univ.-Prof. Dr. Bruno Niederle, Section of Endocrine Surgery, Department of General Surgery, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01222026     History of Changes
Other Study ID Numbers: EK Nr 214/2008, 2008-001703-32
Study First Received: October 15, 2010
Last Updated: July 20, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Primary Hyperparathyroidism
Osteopenia
Osteoporosis

Additional relevant MeSH terms:
Hyperparathyroidism
Bone Diseases, Metabolic
Osteoporosis
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases
Musculoskeletal Diseases
Strontium ranelate
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013