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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism; Osteoporosis; Osteopenia
• Intervention / Treatment: Drug: Strontium Ranelate + Ca/Vitamin-D; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Protelos (r)
Placebo Comparator: Placebo; Receiving Placebo + Ca/Vitamin D	Drug: Placebo; Placebo 1000mg Calcium 800 IE Vitamin-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone mineral density measurement of the Lumbar spine	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: National Bank of Austria
• Investigators: Principal Investigator: Bruno Niederle, Prof., MD, Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Osteoporosis; Osteopenia
• Additional Relevant MeSH Terms: Metabolic Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Parathyroid Diseases; Bone Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Strontium ranelate
• Other Study ID Numbers: EK Nr 214/2008; 2008-001703-32 (EudraCT Number)