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

This study has been completed.
Sponsor:
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Martin Niederle, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01222026
First received: October 15, 2010
Last updated: January 16, 2015
Last verified: January 2015

October 15, 2010
January 16, 2015
September 2010
December 2014   (final data collection date for primary outcome measure)
Bone mineral density measurement of the Lumbar spine [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01222026 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Primary Hyperparathyroidism
  • Osteopenia
  • Osteoporosis
  • Drug: Strontium Ranelate + Ca/Vitamin-D
    2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
    Other Name: Protelos (r)
  • Drug: Placebo
    Placebo 1000mg Calcium 800 IE Vitamin-D
    Other Name: Placebo
  • Active Comparator: Strontium Ranelate
    Receiving Strontium Ranelate + Ca/Vitamin-D
    Intervention: Drug: Strontium Ranelate + Ca/Vitamin-D
  • Placebo Comparator: Placebo
    Receiving Placebo + Ca/Vitamin D
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01222026
EK Nr 214/2008, 2008-001703-32
No
Martin Niederle, Medical University of Vienna
Medical University of Vienna
National Bank of Austria
Principal Investigator: Bruno Niederle, Prof., MD Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
Medical University of Vienna
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP