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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
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

October 15, 2010
July 20, 2011
September 2010
September 2013   (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
Cured Primary Hyperparathyroidism, Concommitant Osteopenia or 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
  • 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.
 
Recruiting
60
September 2013
September 2013   (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: 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
Austria
 
NCT01222026
EK Nr 214/2008, 2008-001703-32
No
Univ.-Prof. Dr. Bruno Niederle, Section of Endocrine Surgery, Department of General Surgery, 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
April 2010

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