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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01222026
First Posted: October 18, 2010
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Martin Niederle, Medical University of Vienna
  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
Primary Hyperparathyroidism Osteopenia Osteoporosis Drug: Strontium Ranelate + Ca/Vitamin-D Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Martin Niederle, Medical University of Vienna:

Primary Outcome Measures:
  • Bone mineral density measurement of the Lumbar spine [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Bone mineral density of the femoral neck [ Time Frame: 1 year ]
  • Bone mineral density of the radius [ Time Frame: 1 year ]
  • Osteoprotegerin (OPG/OCIF) [ Time Frame: 1 year ]
  • RANKL (OPG-ligand) [ Time Frame: 1 year ]
  • cathepsin K (cat K) [ Time Frame: 1 year ]
  • ionised calcium (Ca++) [ Time Frame: 1 year ]
  • phosphate (PO4-) [ Time Frame: 1 year ]
  • alkaline phosphatase (AP) [ Time Frame: 1 year ]
  • bone-specific alkaline phosphatase (BAP) [ Time Frame: 1 year ]
  • osteocalcin (Oc) [ Time Frame: 1 year ]
  • parathyroid hormone (PTH) [ Time Frame: 1 year ]

Enrollment: 63
Study Start Date: September 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01222026


Locations
Austria
Medical University Vienna, General Hospital Vienna (AKH Wien)
Vienna, Austria, 1090
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

Responsible Party: Martin Niederle, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01222026     History of Changes
Other Study ID Numbers: EK Nr 214/2008
2008-001703-32 ( EudraCT Number )
First Submitted: October 15, 2010
First Posted: October 18, 2010
Last Update Posted: January 21, 2015
Last Verified: January 2015

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

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